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ABSTRACTS
Year : 2015  |  Volume : 47  |  Issue : 7  |  Page : 13-57
 

Oral Session Abstracts



Date of Web Publication11-Dec-2015

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How to cite this article:
. Oral Session Abstracts. Indian J Pharmacol 2015;47, Suppl S1:13-57

How to cite this URL:
. Oral Session Abstracts. Indian J Pharmacol [serial online] 2015 [cited 2020 Sep 26];47, Suppl S1:13-57. Available from: http://www.ijp-online.com/text.asp?2015/47/7/13/171569


AIN

AIN-1

In silico Insight into the Binding Interactions of Some Xanthone Derivatives for Anti-inflammatory Activity Targeting Prostaglandin Endoperoxide Synthase-2, their Synthesis and Biological Evaluation


Urvashee Gogoi, Aparoop Das, Satyasish Sandilya, Junmoni Kalita

Department of Pharmaceutical Sciences, Dibrugarh University, Dibrugar, Assam, India

Objectives: To design and synthesize novel 3,6-bis (3'-substituted propoxy) and 3,6-bis(5'-substituted pentyloxy) xanthone derivatives by molecular docking study and to evaluate their anti-inflammatory activity. Materials and Methods: The protein structure was downloaded from RCSB protein databank and the ligands were prepared using Chemdraw freeware. Discovery Studio version 2.5 was used for studying the binding interactions. Molinspiration Cheminformatics and OSIRIS property explorer were utilized online to predict the molecular properties and toxicities of the designed compounds. Fixed dose OECD guideline no. 423 (Annexure-2d) method of CPCSEA was adopted for toxicity studies. Anti-inflammatory activity evaluation was carried out using carrageenan-induced paw oedema model using a plethysmometer (IITCMR 520, IITC Life Sciences, USA) at an interval of ½, 1, 2, 3, 4 and 6 hours after administration of injection. The percentage anti-inflammatory activity was determined in comparison to a reference standard (Diclofenac, 10 mg/kg BW). Results: The in silico ligand binding interactions of compounds S3, S6, S14, S17 and S20 suggested approx. >30% higher binding energy values than the standard diclofenac (Binding energy-155.46 Kcal/mol). In vivo results showed significant reduction in the percentage of inflammation at a dose of 200 mg/kg BW for the same compounds. Conclusion: Molecular docking studies and the in-vivo results have shown significant anti-inflammatory activity in the synthesized 3,6-bis(3'-substituted propoxy) and 3,6-bis(5'-substituted pentyloxy)xanthone derivatives in comparision to the standard, diclofenac. The incorporation of primary and secondary nitrogens in the chemical structure is found to favour the anti-inflammatory potential of the synthesized compounds.

AIN-2

An Obserbvational Study Comparing the Efficacy and Tolerability of Trypsin, Bromelain, Rutoside and Zinc Combintion with Diclofenac Sodium in Patients Suffering from Osteoarthritis Knee Attending Orthopedic OPD, GGH, Anantapuramu


Riyaz N 1 , Santha K 1 , Anandbabu Naik 2

1 Department of Pharmacology, GMC, Anantpur, Andra Pradesh, India, 2 Department of Orthopedics, GGH, Anantpur, Andra Pradesh, India

Objectives: The objective of this study is to compare the efficacy and tolerability of systemic enzyme therapy-trypsin, bromelain, rutoside and zinc combination with diclofenac alone in the management of pain in osteoarthritis knee. Materials and Methods: A randomized observational comparative study to compare the efficacy and tolerability of systemic enzyme therapy versus diclofenac in patients attending orthopedic OPD with episodes of OA knee joint pain. A total of 50 patients with osteoarthritis knee were included in the study, who were divided into two groups of 25 each. One group received diclofenac alone and the other group received a combination of of trypsin, bromelain and rutoside with zinc. Both the groups were followed up for 6 weeks. The efficacy was determined by WOMAC scores, collected before and after the study period. Results: The results of the study are as follows. Within our 6 weeks of observation period, WOMAC scores clearly indicate that the systemic enzyme therapy is equally effective as diclofenac sodium in alleviating pain and reduction of edema. During the study period, both the drugs were well tolerated by both the study groups. Conclusion: Osteoarthritis is a common painful joint disease, which is effectively treated with NSAIDs, most commonly diclofenac; but carries the risk of gastric discomfort, gastric and duodenal ulcer and upper GI bleeding. Systemic enzyme therapy is superior in this aspect as they are free from these adverse effects.

AIN-3

Study of Anti-inflammatory and Analgesic Activity of Moghas (Stem Bark of Litsea glutinosa) in Albino Rats


Abdur Rauf 1 , Arshad Ali 2 , Aftab Ahmad 3 , Akhtar Siddiqui 4

1 Department of Ilmul Advia, AMU, Aligarh, Uttar Pradesh, India, 2 Takmeeluttib College, Lucknow, Uttar Pradesh, India, 3 Department of Ilmul Advia, Faculty of Medicine, Jamia Hamdard, New Delhi, India, 4 Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard, New Delhi, India

Objectives: In order to validate the claims of ancient Unani physicians a scientific study of anti-inflammatory and analgesic activity of a Unani drug "Moghas" identified as stem bark of Litsea glutinosa (Lour.) C.B. Rob. of family Lauraceae was performed because this drug has been using to treat various inflammatory disorders i.e., rheumatoid arthritis and gouty joints successfully in Unani medicine since long period of time. Materials and Methods: The powdered stem bark of Litsea glutinosa was extracted with ethanol and distilled water separately then the dried extract was subjected for investigation of anti-inflammatory and analgesic effects of the drug using carrageenan induced paw oedema test and analgesiometer on tail flick models respectively in albino rats. The aqueous and alcoholic extracts of test drug were used in low doses (900 mg/kg body wt and 1000 mg/kg body wt respectively) and high doses (1300 mg/kg body wt and 1400 mg/kg body wt respectively). The animals were divided into six animals each; the standard drug used was piroxicam 3 mg/kg body wt (orally). The data expressed as Mean ± SEM was analyzed by ANOVA followed by Dunnet, "t" test. Results: In the present study the aqueous and alcoholic extracts of Moghas at high doses exhibited significant (P < 0.01) antiinflammatory activity in carrageenan model in comparison to control group. The aqueous extract of test drug at high dose and alcoholic extract in both doses (low & high) exhibited a significant increase in the reaction time (P < 0.01) in comparison to control group. Conclusion: Based on the findings revealed during the study it was concluded that test drug comprises of different compounds responsible for decreasing the oedema and nociceptive stimuli, hence test drug Moghas possesses anti-inflammatory and analgesic activities.

ANS

ANS-1

Efficacy of Silodosin and Tamsulosin in Patients with Lower Ureteric Calculi in a Tertiary Care Hospital


Sha Naseeruddin, Suresh S Kendri, Imdad Ali

Vijayanagar Institute of Medical Sciences, Ballari, Karnataka, India

Objectives: This study was planned with an objective to compare the efficacy of silodosin and tamsulosin in terms of Stone Expulsion (SE) and Time to Stone Expulsion (TSE). Materials and Methods: A randomized open labeled study was designed to study the efficacy of Silodosin and Tamsulosin in lower ureteric calculi patients. Study population and sample size: This randomized control trial included 100 patients over 18 years of age with stone Size ≤10 mm in distal 1/3 of ureter. Patients were randomly assigned into two groups (A & B). Group A patients were given cap silodosin 8 mg, 1 daily up to 4 weeks while group B patients were given cap tamsulosin 0.4 mg, 1 daily up to 4 weeks. The primary endpoint was expulsion rate. A written informed consent was taken from all the patients. Expulsion time, drug side effects were secondary endpoints. Chi square test and Student t test were used to compare categorical and numerical variables respectively. Results: A stone expulsion rate of 88% (44 patients) was noted in group A and 68% (38 patients) in group B. Group A revealed a statistically significant advantage in term of stone expulsion rate (p = 0.016). Considering expulsion time in days group A showed statistically significant advantage (p = 0.00). Side effects like retrograde ejaculation was more in group A (p = 0.015) and hypotension was significant in group B (p = 0.05). Conclusion: Alpha blocker (Silodosin) is a safe and effective treatment modality for distal ureteral stones of appropriate size.

IMP

IMP-1

Evaluation of Prophylactic Anti-neoplastic Activity of Intra-peritoneal Xenogenic Placental Lysate in Comparison to Placebo in Chemical Induced Hepatocellular Carcinoma in c57bl/6 Mice


Saibal Das, Blessed Winston, Soosai Manickam, Deepak Francis, Margaret Shanthi, Sathya Subramani

Department of Anatomy, Physiology and Pharmacology, Christian Medical College, Vellore, Tamil Nadu, India

Objectives: Immuno-placental therapy has been proposed to prevent multiple cancers. This study was done to evaluate the prophylactic anti-neoplastic activity of xenogenic placental lysate in diethylnitrosamine-induced hepatocellular carcinoma in mice. Materials and Methods: One full-term human placenta was collected and sterile lysate was prepared following standard protocol. Total protein concentration was assessed by bicinchoninic acid assay. Male C57BL/6 mice (3 weeks age, 8-10 g b.w.) were used with 6 animals in each group and treated with: Group 1:20 μg placental lysate i.p. weekly for 3 weeks + diethylnitrosamine 75 mg/kg i.p. weekly from 3 rd to 7 th week; Group 2: equal volume of NaCl (placebo) i.p. weekly for 3 weeks + diethylnitrosamine as above; Group 3: no intervention (control). Mortality rates and changes in body weights were recorded. Histopathological examinations of liver and kidney and alpha-fetoprotein expressions in liver of each animal by immunohistochemistry were done at end. Wilcoxon signed rank test was done using 'R' program (3.1.0) and P < 0.05 was considered significant. Results: There was significant reduction in body weight at time of death in both Group 1 (P = 0.027) and 2 (P = 0.013) mice but not in Group 3 as compared to their body weights before administering diethylnitrosamine. Placental lysate significantly improved survival in Group 1 animals compared to Group 2 ones (P = 0.043). However, cancerous changes in liver were documented by histopathology and immunohistochemistry in both Group 1 and 2 mice but not in Group 3. Conclusion: Placental lysate has improved survival in comparison to placebo in C57BL/6 mice injected with hepatocellular carcinogen.

IMP-2

Effect of Acute and Chronic Ethanol on Behaviour and Ido (Indloeamine 2,3-dioxygenase) Activity in Mice


Arora D 1,2 , Hall S 1,2 , Grant G 1,2 , Mcfarland A 1,2 , Anoopkumar-Dukie S 1,2 , Perkins AV 2 , Davey AK 1,2

1 School of Pharmacy, Griffith University, Gold Coast, Australia, 2 Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia

Objectives: Alcohol use alters inflammatory cell responses and modulates immune responses. Excessive alcohol consumption is associated with increased susceptibility to infection. Binge drinking is becoming a global challenging issue in the younger generations. The aim of this study was to evaluate the neuro-immunomodulatory role of low-moderate and binge alcohol drinking models in mice. Materials and Methods: Male C57BL/6J mice were treated with water (control) or ethanol (5 g/kg and 1.5 g/kg, i.g.; 20% ethanol, w/v) for 1 day or daily for 10 days. Mice were then injected intraperitoneally with saline (control) or LPS (2 mg/kg) in saline 24 hours after the last dose of ethanol. Open field test, forced swimming test and tail suspension tests were performed to assess the baseline, ethanol and ethanol + LPS induced behavioural changes. HPLC methods were employed to measure the monoamine levels and kynurenine to tryptophan ratio used as a marker of IDO activity. Results: Low dose of ethanol produced anxiogenic behaviour in mice and the high dose animals showed a characteristic hangover effect after the blood alcohol levels declined. Both doses of ethanol modulated the LPS induced sickness behaviour, as well as the tryp/kyn ratio, indicating the activity of IDO. A single low dose of ethanol reduced the impact of depressive-like behaviour induced by LPS; however, chronic high dose administration had an opposite effect.

IMP-3

A Novel Epitope Prediction for Vaccine Designing Against Ebola Viral Envelope Proteins


Surabhi Johari, Manju Kanu

Centre for Bioinformatics Studies, Dibrugarh University, Dibrugarh, Assam, India

Objectives: Viral proteins of Ebola viruses belong to one of the best studied viruses; however no effective prevention against EBOV has been developed. Epitope-based vaccines provide a new strategy for prophylactic and therapeutic application of pathogen-specific immunity. A critical requirement of this strategy is the identification and selection of T-cell epitopes that act as vaccine targets. This study describes current methodologies for the selection process, with Ebola virus as a model system. Hence great challenge in the field of ebola virus research is to design universal vaccine. Materials and Methods: A combination of publicly available bioinformatics algorithms and computational tools are used to screen and select antigen sequences as potential T-cell epitopes of supertypes Human Leukocyte Antigen (HLA) alleles. MUSCLE and MOTIF tools were used to find out most conserved peptide sequences of viral proteins. Immunoinformatics tools were used for prediction of immunogenic peptides of viral proteins in zaire strains of Ebola virus. Putative epitopes for viral proteins (VP) were predicted from conserved peptide sequences of VP. Three tools NetCTL 1.2, BIMAS and Syfpeithi were used to predict the Class I putative epitopes while three tools, ProPred, IEDB-SMM-align and NetMHCII 2.2 were used to predict the class II putative epitopes. B cell epitopes were predicted by BCPREDS 1.0. Results: Immunogenic peptides were identified and selected manually by putative epitopes predicted from online tools individually for both MHC classes. Finally sequences of predicted peptides for both MHC classes were looked for common region which was selected as common immunogenic peptide. The immunogenic peptides were found for viral proteins of Ebola virus: epitopes FLESGAVKY, SSLAKHGEY. Conclusion: These predicted peptides could be promising candidates to be used as target for vaccine design.

IMP-4

Traditional Chinese Medicines Regulate Major Components of Immune Response


Xin Chen

State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao SAR, China

Objectives: Chemokines participate in leukocyte trafficking and homing as well as in immune responses. Dendritic cells (DCs) represent a heterogeneous population of professional antigen-presenting cells (APCs) that play a central role in the initiation and regulation of immune responses. CD4 + Foxp3 + regulatory T cells (Tregs) are crucial in the immune homeostasis and control a wide spectrum of immune response. We systemically investigated the effect of traditional Chinese medicine (TCM)-derived compounds on these major components of immune response. Materials and Methods: We have studied TCM as source of regulators of chemokine network, DCs and Tregs through in vitro and in vivo experiments. Results: Starting from multiple component herbal products, we have identified a number of biochemically defined chemokine/chemokine receptor antagonists, such as bile acid and shikonin. Triptolide (TPT) is a potent immunosuppressive compound isolated from an anti-inflammatory Chinese herbal medicine. We found that triptolide, a compound isolated from an anti-inflammatory herb, potently inhibited DC maturation and trafficking over a pharmacological concentration range. Our preliminary data showed that an immunosuppressive compound from TCM has in vivo activity to expand Tregs, probably by generating tolerogenic DCs. Conclusion: Our work suggests that TCM have the capacity to target various major components and check points of immune response, including chemokine and chemokine receptor network, DCs and Tregs. Further study may be helpful to elucidate the immunological basis for the clinical action of TCM, and may lead to the discovery of novel therapeutic agents from TCM for the treatment of major human diseases.

BHP

BHP-1

Impact of Adverse Drug Reactions on Quality of Life in Patients with Schizophrenia in a Tertiary Care Hospital, Assam


Neog P, Roy D

Department of Pharmacology, Silchar Medical College, Silchar, Assam, India

Objectives: (1) To detect the adverse drug reactions of antipsychotic drug in patients with schizophrenia in the department of psychiatry. (2) To assess the quality of life in those patients with schizophrenia. Materials and Methods: It is a prospective observational study. The ADRs of antipsychotic drugs used in schizophrenic patients is analyzed in the department of psychiatry. Patients, who are diagnosed as schizophrenia with antipsychotic medication irrespective of age and sex and above 18 years (excluding pregnant woman) are included. ADR's reported spontaneously by the patients and also detected by physician is recorded in the case record form. Quality of life is assessed with the help of SF-36 HRQOL and World Health Organization Quality of Life BREF (WHOQOL-Bref) questionnaire method and scoring system. Results: Up till now 22 schizophrenic patients is studied. Out of them 16 patients suffered from different kinds of ADRs. The quality of life is measured at initial visit and also after the occurrence of ADR. The final results of impact of QOL in those patients and statistical analysis will be shown at the time of presentation. Conclusion: From the above observations and results, till now we can conclude that ADRs are very much prevalent in schizophrenic patients. The final conclusion of the results will be provided at the time of presentation.

BHP-2

Ethanolic Extract of Centella Asiatica (L.) Supress Behavioral Abnormalities in Valproate-induced Autism


Sibi Ittiyavirah 1 , Gifty Jacob 1 , Krishnakumar IM 2 , Kannan R 1

1 Department of Pharmaceutical Sciences, Division of Neuropharmacology, Mahatma Gandhi University, Cheruvandoor Campus, Kottayam, Kerala, India, 2 Akay Flavors and Aromatics Pvt. Ltd., Ernakulam, Kerala, India

Objectives: Autism is a congenital neurological disorder characterized by impairment of socialization, abnormalities of communication, limited activity and curiosity. Pre and post natal exposure of teratogens like Valproic acid, Thalidomide, Ethyl alcohol etc could induce behavioral alterations similar to autism. In the present study we investigated the effect of ethanolic extract of Centella asiatica (EECA) on valproic acid induced autistic pups. Materials and Methods: Rat pups of both sex received a single dose of Valproic acid (VPA) 400 mg/kg/s.c. on 14 th post natal day (PND). Pups were observed for weight gain and negative geotaxis on PND13-19. Autistics pups were divided into 2 groups (A&B respectively). First group received EECA (300 mg/kg/p.o.) while, the second group received normal saline (0.9% p.o.) on PND 21-35 and group C acts as control group. Behavioral parameters such as locomotor, nociception, exploratory, anxiety and spatial memory were assessed on PND 31-40. The animals were sacrificed and anxiety related markers like serotonin, nitric oxide and reduced glutathione were estimated on 41 st day. Results: The VPA induced behavioral abnormality, hyperserotonemia and oxidative stress were reversed by treatment with EECA. Conclusion: It is concluded that EECA have neuroprotective, antianxiety and antioxidant activities and may be effective in countering behavioral abnormalities of autism.

BHP-3

Preclinical Evaluation of Tragia Plukenetii Plant Leaf Extracts for Nootropic Activity


Sree Vaishnavi, Eswar Tony, Sathish Kumar, Narendra Babu, Rama Rao

Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Predhesh, India

Objectives: To carry out the preclinical evaluation of benzene, chloroform and methanolic extracts of the leaves of Tragia plukenetii A.R. Smith for nootropic activity using exteroceptive aversive stimuli models. Materials and Methods: The preclinical evaluation of standardized benzene, chloroform and methanolic extracts of the leaves of Tragia plukenetii A.R. Smith for nootropic activity was carried by using the following exteroceptive aversive stimuli models: (a) spatial long term memory elevated plus maze, (b) working memory 8 arm radial maze, (c) spatial working memory Y maze, (d) learning, memory & reasoning hebb's William maze & labyrinth maze, e) ischemia induced amnesia rectangular maze. Results: Behavioral models for studying drugs or conditions that affect cognitive processes was standardized and evaluated by using leaf extracts of Tragi plukenetii A.R. Smith. The methanolic leaf extract of Tragia plukenetii A.R. Smith has shown significant nootropic activity (p < 0.05 against control and standard group) by all the employed exteroceptive aversive stimuli models due to the presence of flavonoids. Conclusion: Hence from the above study it can be concluded that phytocompounds from Tragia plukenetii A.R. Smith can be exploited as a therapeutic agent or adjuvant in existing therapy for the treatment.

BHP-4

Effect of Minocycline on Alcohol Withdrawal Anxiety in Rats


Maurya MR, Petare AU, Gajbhiye SV, Tripathi RK

Department of Pharmacology and Therapeutics, Seth GSMC and KEM Hospital, Parel, Mumbai, Maharashtra, India

Objectives: Evaluation of effect of minocycline on alcohol withdrawal anxiety in experimental model. Materials and Methods: Model of alcohol withdrawal anxiety was standardized in male Wistar rats. Alcohol was only fluid source administered through a forced drinking procedure of 22 days. Alcohol was given in gradually increasing concentration of 4% (Day 1-3), 8% (Day 4-6), 16% (Day 7-22). At the end of alcohol withdrawal animals will receive respective drugs 30 min prior to withdrawal of alcohol which include minocycline 7, 21, 35 mg/kg and diazepam 1 mg/kg. Variables were assessed using anxiety score, elevated plus maze (EPM) and two chambered box at baseline, 1 and 3 hour after alcohol withdrawal. Statistical test used were repeated measure ANOVA for within group and ANOVA for intergroup analysis with post hoc turkey's test. Results: Post induction of withdrawal symptoms in alcohol deprived animals anxiolytic activity of test compound was compared with diazepam. Total anxiety score at 3 hour was significantly lower in minocycline 35 mg/kg group compared to vehicle. In EPMrats treated with Minocycline (35 mg/kg) showed increase in time spent in openarms at 1 hr. However at 3 hr all doses of minocycline showed statistically significant increase compared to vehicle in a dose-dependent manner (p < 0.05). Highest dose tested (35 mg/kg) produced effect that was comparable to the standard drug diazepam. All doses of minocycline showed significant increase in the number of rears in open arm at 1 and 3 hr. In two chambered box latency to enter brightly lit chamber at 3 hrs was significantly increased in all the study groups compared to vehicle. Conclusion: Our results suggest that minocycline had some significant beneficial effects on alcohol withdrawal anxiety in rats and may be useful alternative to diazepam.

IND

IND-1

Investigation of Molecular Mechanism Involved in Reduced Adipogenesis, Steatosis and Lipotoxicity by Supplementation of Piperine in WNIN Obese Rats


Harishankar N, Sailaja P, Suresh P

National Centre for Laboratory Animal Sciences, National Institute of Nutrition, ICMR, Hyderabad, Telangana, India

Objectives: Obesity is considered as dreaded killer lifestyle disease and is a global health concern and associated with severe metabolic complications. There is an urgent need to identify breakthrough drugs with paradigm shifting in pharmaco dynamics for treating obesity. Piperine is one of the bioactive compounds isolated from Piper nigrum Lin. having health promoting properties. The present study is aimed to see the effect of piperine on WNIN obese rats. Materials and Methods: 36 obese rats of 35 days age were taken and randomly divided in to three groups. Group-I rats were fed with standard rodent chow, Group-II rats fed with 0.1% Piperine and Group-III fed 0.2% Piperine for a period of 8 weeks. Parameters like growth, food intake were monitored in all the three groups. Body composition analysis was carried out by total body electrical conductivity, serum lipid profile, and circulating levels of adiponectin, IL6 and TNF-α levels were estimated by ELISA kits. The experimental obese rats showed a significant decrease in their body weight and food intake compared to control and continued to be low till the end of the experiment. Results: The total body fat was significantly reduced and the lean body mass increased in experimental rats. Piperine supplementation decreased lipid accumulation and steatosis, which resulted from both decreased lipogenesis and increased fatty acid oxidation. It also inhibited adipogenesis possibly by reverting transcription factors PPARg and its target genes. The beneficial effects of Piperine can be attributed to the presence of rich phytochemicals and antioxidant. Conclusion: The present study indicates the therapeutic potential of piperine in treating obesity, hyperlipidemia and associated dietary obesity disorders.

IND-2

A Study of the Hypolipidemic and Antioxidant Activities of Whole Plant Extracts of Ipomoea Aquatica Forsk. in Experimentally Induced Hyperlipidemia in Rabbits


Aziz Sahid, Gohain Kalpana

Department of Pharmacology, Assam Medical College, Dibrugarh, Assam, India

Objectives: The aim of the study has been to investigate the possible hypolipidemic and antioxidant properties of the whole plant extract of Ipomoea aquatica in experimentally induced hyperlipidemia in rabbits. Materials and Methods: Ethanolic extract of the whole plant of I. aquatica (EEWPIA) was prepared by percolation method. The extract was evaluated for hypolipidemic and antioxidant activities using 400 mg/kg body weight per day in a high fat diet induced hyperlipidemia in rabbits. The results were analyzed using one way analysis of variance (ANOVA) followed by Bonferroni's multiple comparison test and compared to the normal control, experimental control and the standard drug (atorvastatin 2.1 mg/kg body weight per day) groups. The results were expressed as mean ± standard error of mean (SEM). Values with p < 0.05 were considered significant. Results: Oral administration of EEWPIA in the test group showed significant reduction in the serum levels of total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and significant increase in the high density lipoprotein cholesterol (HDL-C) when compared to the experimental control group. There were also significantly elevated catalase and superoxide dismutase (SOD) activities and significantly lower malondialdehyde (MDA) levels in the test group compared to the experimental group. Similar results were also found in the standard drug group. Conclusion: The results of our experiment demonstrated that EEWPIA possess significant antihyperlipidemic and antioxidant activities and hence could be a potential source of medication as adjuvant to the existing therapy for treatment of dyslipidemia.

IND-3

Anti-diabetic Activity of Modified Shilajatvadi Lauha in Streptozotocin Nicotinamide Induced Diabetic Rats


Singh TR 1 , Gupta LN 2 , Kumar N 2 , Kumar V 3

1 Department of Rasashastra and Bhaishajya Kalpana Including Drug Research, Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India, 2 Department of Rasa Shastra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 3 Department of Pharmaceutics, Neuropharmacology Research Laboratory, Indian Institute of Technology, Banaras Hindu University, Varanasi, Uttar Pradesh, India

Objectives: To assess the effect of Shilajatvadi Lauha processed with Berberis aristata D.C. (Modified Shilajatvadi Lauha/MSL) on blood glucose and plasma insulin level in streptozotocin (STZ)-nicotinamide induced diabetic rats. Materials and Methods: Type 2 diabetes in rats was induced with STZ-nicotinamide. MSL (10, 30 and 100 mg/kg) and glibenclamide (10 mg/kg) were orally administered once daily to diabetic rats for 14 days. After 14 days treatment, fasting blood glucose and plasma insulin level were assayed. Results: MSL significantly lowered the blood glucose and increases insulin level, which was comparable to the standard anti-diabetic drug, glibenclamide. Conclusion: Modified Shilajatvadi Lauha possesses significant anti-diabetic activity in Streptozotocin-nicotinamide induced diabetic rats. The results are encouraging and can be studies further to evaluate exact mechanism of action to develop a novel molecule that will benefit the ailing.

IND-4

Comparative Study of Antidiabetic, Antihyperlipidaemic and Antioxidant Activities Between the Ethanolic Extracts of Roots and Leaves of Erythrina Stricta Roxb. in Streptozotocin-nicotinamide Induced Type 2 Diabetic Rats


Kurmi P, Das S

Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Assam, India

Objectives: The present study was carried out to evaluate and compare the antidiabetic, antihyperlipidaemic and antioxidant activities of ethanolic extract of roots and leaves of Erythrina stricta Roxb. and also to explore the probable mechanism of the antidiabetic action of Erythrina stricta Roxb. in streptozotocin-nicotinamide induced type 2 diabetic rats. Materials and Methods: A single intraperitoneal injection of streptozocin 60 mg/kg 15 minutes after intraperitoneal injection of nicotinamide 110 mg/kg was injected in rats to induce type 2 diabetes mellitus. Rats with blood glucose level >250 mg/dl was considered diabetic and taken in the experiment. Oral administration of the ethanolic extract of roots (EERESR) and leaves (EELESR) were administered per orally for at the dose of 500 mg/kg for 14 days. Blood glucose, serum insulin, serum lipid profile and antioxidant parameters were evaluated at the 1 st and 15 th day of the experiment. The effect of the EERESR and EELESR on intestinal glucose absorption was evaluated on rats. Results: Streptozocin-nicotinamide induce type 2 diabetic rats showed significant hyperglycaemia with alteration of serum insulin, lipid profile and antioxidant (malondehyde, catalase and superoxide dismutase) levels. On treatment with test drugs EERESR, EELESR and standard drug glibenclamide there was significant fall in blood glucose level, serum lipid profile and antioxidant variables and also rise in serum insulin level. EERESR and EELESR showed inhibitory activity on intestinal glucose absorption. Among the two test drugs EERESR has shown more antidiabetic, antihyperlipidaemic and antioxidant activity compared to EELESR. Conclusion : It can be concluded that the both roots and leaves of Erythrina stricta Roxb. are having antidiabetic, antihyperlipidaemic and antioxidant activities. EERESR having more prominent antidiabetic, antihyperlipidaemic and antioxidant effect. It can be a potential source of newer antidiabetic drug which needs further investigation.

IND-5

Pharmacological Potential of Pinus wallichiana and Pinus gerardiana from Indian Himalayas for Osteoporosis in Female Rats


Aditi Sharma, Rohit Goyal

School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives: Pinus species are abundantly found in higher areas of Indian Himalayan region and traditionally being used for treating bone fragility and fractures. The present investigation was designed to explore the anti-osteoporotic potential of Pinus wallichiana and Pinus gerardiana in female rats. Materials and Methods: Female wistar rats (220-260 g) were divided into 7 groups. Rats were anaesthetized with chloral hydrate (300 mg/kg, i.p) and ovaries were removed bilaterally resulting in post-menopausal syndrome. In sham treated rats, animals were exposed to only surgical procedures. Group 2 serve as an overiectomized control. Group 3 was administered raloxifene (1 mg/kg, p.o). The other groups were treated with extract of Pinus wallichiana and Pinus gerardiana (100 & 200 mg/kg, p.o.) for 90 days from the 15 th day of overiectomy. Biomechanical (three point bending of tibia, femoral neck load testing, compression of fourth lumbar vertebra), biochemical (alkaline phosphatase, calcium, inorganic phosphorus, estradiol) and histopathological parameters (femur) were also determined. Results: The findings assessed on the basis of biochemical, biomechanical and histopathological parameters that Pinus wallichiana and Pinus gerardiana possess anti-osteoporotic activity as extract leads in an increase biomechanical strength, higher osteoblastic activity and minimal osteoclastic activity, which in turn prevents osteoporosis. HPLC analysis of hydroalcoholic extracts shows established unbound gallic acid and quercetin. Conclusion : The results from the present study suggest the preventive effect of Pinus wallichiana and Pinus gerardiana in osteoporosis.

IND-6

Comparative Study of Antidiabetic, Antihyperlipidaemic and Antioxidant Activities Between the Ethanolic Extracts of Roots and Leaves of Erythrina stricta Roxb. in Streptozotocin Induced Type 1 Diabetic Rats


Soleman Khan, Swarnamoni Das

Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Assam, India

Objectives: The present study was carried out to evaluate and compare the antidiabetic, antihyperlipidaemic and antioxidant activities of ethanolic extract of roots and leaves of Erythrina stricta Roxb. and also to explore the probable mechanism of the antidiabetic action of Erythrina stricta Roxb. in streptozotocin induced type1 diabetic rats. Materials and Methods: Type 1 diabetes will be induced in rats by injecting freshly prepared streptozotocin in 0.1 mol/L citrate buffer solution (pH 4.5) intraperitoneally with a single dose of 60 mg/kg. Ethanolic extract of roots (EERESR) and leaves (EELESR) were administered per orally at the dose of 500 mg/kg for 14 days. Blood glucose, serum insulin, serum lipid profile and antioxidant parameters were evaluated at the 1 st and 15 th day of the experiment. The effect of the EERESR and EELESR on intestinal glucose absorption was evaluated on rats. Results: Streptozotocin induced type 1 diabetic rats showed significant hyperglycaemia with alteration of serum insulin, lipid profile and antioxidant (malondehyde, catalase and superoxide dismutase) levels. On treatment with test drugs EERESR, EELESR and standard drug insulin, there was significant fall in blood glucose, increase serum insulin level, and changes in serum lipid profile and antioxidant variables. EERESR and EELESR showed inhibitory activity on intestinal glucose absorption. EERESR has shown more antidiabetic, antihyperlipidaemic and antioxidant activity compared to EELESR. Conclusion: It can be concluded that the both roots and leaves of Erythrina stricta Roxb. are having antidiabetic, antihyperlipidaemic and antioxidant activities. EERESR having more prominent antidiabetic, antihyperlipidaemic and antioxidant effect. It can be a potential source of newer antidiabetic drug which needs further investigation.

IND-7

Pharmacological Assays as Tool for Quality Control of Herbal Drugs


Shital Giramkar 1 , Supriya Bhalerao 1 , Soumya Koppikar 1 ,

Manasi Deshpande 2 , Omkar Kulkarni 3

1 Interactive Research School for Health Affairs, BVDU, Pune, Maharashtra, India, 2 College of Ayurved, BVDU, Pune, Maharashtra, India, 3 Vishwanand Kendra-Centre for Integrative Medicines and Research, Pune, Maharashtra, India

Objectives: Herbal drugs are gaining an increasing attention in recent years due to their safety, long history of use & natural availability. However, their quality poses a great challenge. This issue is more pronounced in case of rare, endangered and threatened plants like (NJ). Material and Methods: In the present study, we employed pharmacological assays to compare and thereby standardize rhizomes of three plant species generally used under the name of Jatamansi viz. Nardostachys jatamansi DC, Tagar (Valeriana wallichii Jones Syn.) and Kushtha (Saussurea lappa C.B. Clarke). We performed anti-oxidant activity (using total phenol, flavanoid content, DPPH free radical scavenging activity, ferric reducing potential & anti-lipid peroxidation), acetyl cholinesterase inhibitory activity and toxicity on primary cultured neuronal cells using standard protocols on hydro-alchoholic extracts of the 3 rhizomes. Results: We observed comparable phenolic content in Jatamansi & Tagar while the lowest content was found in Kushtha (1.92 mg/gm dry mass of GAE). Flavanoid content was found higher in Tagar (1.7 mg/gm dry mass of quercetin). DPPH scavenging activity & anti lipid peroxidation activity were found higher in Tagar indicating better free radical scavenging potential. The ferric reducing potential of all 3 extracts was comparable, though N. Jatamansi showed slightly higher activity. Kushtha demonstrated lowest acetyl cholinesterase inhibitory activity at all studied concentrations as compared to other 2 plants. Tagar showed cell toxicity at 80 μg/ml, whereas Jatamansi was found non-toxic even at 160 μg/ml. Conclusion: The differences in the activities adequately highlight that pharmacological assays can prove a tool for herbal drugs standardisation along with microscopic and physicochemical characteristics.

IND-8

To Evaluate the Efficacy of Carica papaya Leaf Extract on Platelet Count in Dengue Induced Thrombocytopenia: A Randomized Controlled Trial


Dharani S 1 , CR Jayanthi 1 , Raveendra KR 2

1 Department of Pharmacology, Bangalore Medical College &Research Institute, Bangalore, 2 Department of Medicine, Bangalore Medical College &Research Institute, Bangalore, India

Objectives: Dengue, a mosquito borne viral disease has become a growing threat to public. India, with an annual average incidence of 20,474 cases and 132 dengue-related deaths, is one among the hyperendemic countries. It is characterized by fever, rash, haemoconcentration and thrombocytopenia. A significant number of patients succumb during the thrombocytopenic period. Of late, Carica papaya leaf extract (CPLE) which can significantly increase the platelet count is being studied extensively in trials, the results of which have been encouraging. To evaluate the efficacy of CPLE in dengue induced thrombocytopenia. Materials and Methods: After obtaining IEC approval and written informed consent, 40 subjects diagnosed to have dengue and positive for NS1 antigen were enrolled in this study. Both the test and control arms (n = 20) received the standard treatment for dengue. Test group, in addition received CPLE 1100 mg thrice daily for 5 days. Platelets were monitored daily and outcome was measured on day 2 and day 5 from baseline. The patients were followed up for a total period of 2 weeks for any adverse effects. Results: The mean increase in platelet count from baseline was 6900 ± 5780/mm 3 and 20450 ± 14940/mm 3 on day 2 and 23200 ± 10561/mm 3 and 59700 ± 28977/mm 3 on day 5 in the control and test groups respectively. It was statistically more in the CPLE group as compared to the control group on both day 2 (p < 0.001) and day 5 (p < 0.0001) with no significant adverse effects. Conclusion: CPLE may be an effective treatment option in dengue induced thrombocytopenia as it significantly increased the platelet count with good patient tolerability.

IND-9

In-vitro Anticataract Activity of Ethanolic Extract of Whole Plant of Ipomea aquatica Frosk on Goat Lens


Borah Jyoti, Das Swarnomoni

Depatment of Pharmacology, Assam Medical College, Dibrugarh, Assam, India

Objectives: To study the in-vitro anticataract activity of ethanolic extract of whole plant of Ipomea aquatica Frosk (EEIA) on goat lens. Materials and Methods: Ethanolic extract of whole plant of Ipomea aquatica Frosk (EEIA) was prepared by percolation method. Artificial aqueous humour was prepared and 32% Penicillin G and 250% Streptomycin were added to it. Goat lens were divided into 6 groups with 5 lenses in each group. They were incubated in artificial aqueous humour for 72 hrs at room temperature with 5.5 mM glucose (negative control group), 55 mM glucose (cataractogenesis group), Enalapril 5 ng/ml (standard drug group), and EEIA (1 mg/kg, 1.5 mg/kg, 2 mg/kg). After 72 hrs incubation visual evaluation was done by placing the lens on a graph paper and counting the numbers of squares visible through it as a measure of lens opacity. Then 10% w/v lens homogenate were prepared in Tris buffer containing EDTA and used for estimating catalase activity, MDA by TBA method, SOD and total protein by Lowry's method. Results: Lens treated with the EEIA at concentrations of 1.5 mg/kg and 2 mg/kg showed significantly (p < 0.05) decreased opacity and decreased tissue MDA level, increased catalase and SOD activities and increased total protein and water soluble protein levels respectively compared to the positive control. Conclusion: The present study showed that EEIA has anticataract activity which can be attributed to its antioxidant properties.

IND-10

In-vitro Anticataract Activity of Ethanolic Extract of Shoots of Bambusa balcooa on Goat Lens


Dey Sanjoy, Das Swarnamoni

Departmen of Pharmacology, Assam Medical College, Dibrugarh, Assam, India

Objectives: To study the in-vitro anticataract activity of ethanolic extract of shoots of Bambusa balcooa (EESBB) on goat lens. Materials and Methods: Ethanolic extract of shoots of Bambusa balcooa (EESBB) was prepared by Percolation method. Goat lenses were made in 6 groups with 5 lenses in each group. Artificial aqueous humor was prepared and 32% Penicillin G and 250% Streptomycin were added to it. They were incubated in artificial aqueous humor for 72 hrs at room temperature with 5.5 mM glucose (negative control group), 55 mm glucose (cataractogenesis group), enalapril (standard drug group) and 3 dosage of EESBB (1 mg/kg, 1.5 mg/kg, 2 mg/kg) with 55 mm glucose (test drug groups). Opacification of lens was assessed by counting the number of clear squares when placed over a graph paper. Parameters studied were catalase and superoxide dismutase (SOD) activities, tissue Malondialdehyde (MDA) and total and water soluble protein in the lens homogenate. Results: Glucose induced opacification of lens was started 10-12 hours post incubation & was completely opacified in 72 hrs. Lens treated with the EESBB at concentrations of 1.5 mg and 2 mg showed significantly (p < 0.05) decreased opacity and decreased tissue MDA level, increased catalase and SOD activities and increased total protein and water soluble protein levels respectively compared to the positive control. Conclusion: Hence the study suggested that EESBB possesses significant anticataract activity which can be attributed to its antioxidant property.

IND-11

Cardioprotective Effects of Crataegus oxycantha and its Mechanism


Harshul Parikh 1 , Tripathi CB 2 , Upadhyay MG 1 , Vaghela PD 1 , Goyal RK 3

1 Shantilal Shah Pharmacy College, M.K. Bhavnagar University, Bhavnagar, Gujarat, India, 2 Department of Pharmacology, Government Medical College, Bhavnagar, Gujarat, India, 3 VClinBio Labs, Shri Ramachandra Medical Centre, Shri Ramachandra University, Chennai, Tamil Nadu, India

Objectives: Crataegus oxycantha has been traditionally used as cardiotonic to treat the early stages of congestive heart failure and angina pectoris, however, till date very few authentic investigational studies addressing its cardioprotective use. We aimed to study cardioprotective effect of C. oxycantha and to elucidate its possible mechanism. Materials and Methods: The extract of C. oxycantha was evaluated for its cardiprotective effects and possible mechanism of action in isoproterenol (ISO) induced myocardial toxicity by assessing serum and tissue biochemical parameters. Results: The pretreatment with C. oxycantha significantly prevented the increase in serum Cardiac troponin I (cTnI), Creatine kinase-MB (CK-MB), Lactate dehydrogenase (LDH), Glutamate oxalotransaminase (SGOT), Glutamate pyruvate transaminase (SGPT) and Uric acid in Isoproterenol (ISO) (100 mg/kg) injected rats. The pretreatment with C. oxycantha in ISO treated animals produced significant decrease in LPO and significant increase in endogenous antioxidants SOD, catalase and reduced glutathione in myocardial tissue. The C. oxycantha extract significantly inhibited Na + -K + ATPase enzyme present in heart homogenate by virtue of presence of ursolic acid as evidenced by HPTLC analysis of C. oxycantha extract, which may be the possible mechanism of cardiotonic activity of C. oxycantha. Conclusion: Crataegus oxycantha may be viewed as potentially cardiotonic, cardioprotective and anti-oxidant.

IND-12

A Comparative Study of Hepatoprotective Effect of Curcumin with N-acetyl Cysteine and their Simultaneous Administration in Acetaminophen Induced Hepatotoxicity


Potey AV, Chauthankar SA, Bhide SS, Tadavi FM

Department of Pharmacology and Therapeutics, Seth GSMC and KEM Hospital, Parel, Mumbai, Maharashtra, India

Objectives: Hepatotoxicity is the most serious fatal complication of acetaminophen overdose. N-acetyl cysteine is the only antidote for this condition. Curcumin has known hepatoprotection for acetaminophen induced hepatotoxicity in animal studies. To compare the hepatoprotective efficacy of curcumin with N-acetyl cysteine and their simultaneous administration in a standardised model of acetaminophen induced hepatotoxicity in Wistar rats. Materials and Methods: 60 Wistar rats were divided into 10 groups with drugs administered orally normal control, vehicle control, disease control, standard control, curcumin at 300, 600 and 900 mg/kg doses in each group, N-acetyl cysteine (NAC) 150 mg/kg and curcumin 300 mg/kg, NAC 300 mg/kg and curcumin 600 mg/kg and NAC 200 mg/kg (intra-peritoneally) and curcumin 300 combination groups. Liver function tests, tissue oxidative markers and histopathology of liver tissue were analysed and compared in the groups. Results: No significant variation between the NAC300, C600, C900, NAC150 + C300, NAC300 + C600 and NAC200 + C300 groups in the serum functional liver enzyme levels and liver tissue reduced glutathione levels. Among the standard control (263.75 + 5.22 μmol/gm), C600 (205.54 + 6.66 μmol/gm), C900 (198.1 + 5.09 μmol/gm), NAC150 + C300 (274.11 + 7.05 μmol/gm), NAC300 + C600 (248.29 + 14.74 μmol/gm) and NAC200 + C300 (212.68 + 7.58 μmol/gm), the significantly lower values of mean liver malonaldialdehyde levels were found in the C600 and C900 groups. Conclusion: Doses of curcumin and N-acetyl cysteine for hepatoprotection in acetaminophen induced hepatotoxicity, can be halved for administration when used in combination. Combination of N-acetyl cysteine and curcumin shows hepatoprotection by increasing liver GSH levels. Tissue histology is well preserved with use of curcumin or combination of curcumin and N-acetyl cysteine in hepatotoxic rats than N-acetyl cysteine used alone.

IND-13

Investigation on Seeds of Annona muricata L. for Potential Antioxidant and Anticancer Activity


Behzad Mohaddesi 1 , Ashvin Dudhrejiya 2 , Sheth NR 1 , Vadalia J 1

1 Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India, 2 B.K. Mody Government Pharmacy College, Rajkot, Gujarat, India

Objectives: The current problem in modern lifestyle is rise of different disorders such as cancer in most of industrialized and developing country worldwide. With this concern, the role of reverse pharmacology is to help the ethno pharmacological knowledge on natural products and discover the new therapeutic agents for treatment and control of such conditions. Hence, the aim of this study was to find out the potential medicinal value from the seeds of Annona muricata the important medicinal plant of annonaceae family. Materials and Methods: Proper phytochemical study performed on the seeds of A. muricata, different extracts optioned and subjected to anti oxidant tests. SRB assay performed on crud and purified extracts on different human colon cancer cell lines and compared with of adriamycin (doxorubicin) a known standard drug to find out the active compounds. Results: The investigation proof the potential anti oxidant activity of the seeds of A. muricata, growth inhibition of 50% (GI 50 ), drug concentration resulting in total growth inhibition (TGI) and lethal concentration 50% (LC 50 ) calculated and seeds showed significant activity on extracts and the fractions with GI 50 of <15 on the cell lines which shows the strong anti cancer activity. Conclusion: To find out the new anti cancer agents from natural products, in vitro anti oxidant tests and cytotoxicity studies are important as an initial step on drug discovery process. In this study all the tests indicate the high medicinal value of the seeds of A. muricata, that can be utilize from its edible fruit for different medicinal use, also prevention and control of cancer.

IND-14

Aqueous extract of Ganoderma lucidum prevent transvascular leakage in rat lung and hypothermia following hypobaric hypoxia exposure


Tulsawani R, Manickam M, Suryakumar G, Kaur N

Department of Biochemical Sciences (DBCS), Defense Institute of Physiology and Allied Sciences, DRDO, Ministry of Defense, Government of India, Lucknow Road, Timarpur, Delhi, India

Objectives: To evaluate protective -efficacy of aqueous extract of Ganoderma lucidum against hypoxia induced transvascular leakage and hypothermia in experimental animals. Materials and Methods: Rats were exposed to hypobaric hypoxia (25000 fts) for 6 h in the presence or absence of aqueous extract of Ganoderma lucidum for transvascular leakage studies and in separate study; rats were restrained and exposed in a Cold-Hypoxia-Restrain decompression chamber maintained at 5°C to an altitude of 15000 fts for studying adaptogenic activity. A rectal probe was inserted 2 cm past the rectum and retained there with the help of adhesive plaster. After exposure period, rat lung and muscles were excised and homogenized for measuring tissue MDA, ROS, GSH, GPx and SOD levels; and NFκB, TNFα, IL6 and Nrf2 expressions. Results: The rat lungs exposed to hypoxia showed more retention of water in comparison to the control groups and treatment of rats with extract prevented such changes induced following hypobaric hypoxia exposure. Further, sodium fluorescein dye leakage was found to be elevated significantly in rat lung which was observed to be reduced in extract treated rats. In another preliminary study, administration of extract at dose 100 mg/kg was effective in providing resistance to C-H-R induced hypothermia (T rec 23°C) by 19.5 % however extract could not fasten recovery from post hypoxic hypothermia in these animals. Further, elaborate studies are required to understand the observed facts on extract induced resistance on hypothermia in detail before confirming its adaptogenic potential. Extract treatment prevented changes in oxidative stress markers (MDA, ROS, GSH, GPx and SOD); de-activated inflammatory response and revealed higher expressions of Nrf2 in rat lung and muscles indicating its strong anti-oxidant potential of extract. Conclusions: Overall, aqueous extract of Ganoderma lucidum treatment prevented hypoxia induced transvascular leakage by inducing strong antioxidant response via activation Nrf2 mediated pathways and resistance to hypothermia.

IND-15

A study of the hypolipidemic and antioxidative activities of shoots of Bambusa balcooa roxb. in experimentally induced hyperlipidemia in rabbits


Gogoi Dipankar Mall, Deori Chinmoyee

Department of Pharmacology, Assam Medical College, Dibrugarh, Assam, India

Objectives: The aim of the study was to evaluate the potential hypolipidemic and antioxidative properties of the extract of Bambusa Balcooa shoots in experimentally induced hyperlipidemia in rabbits. Materials and Methods: Ethanolic extract of Bambusa balcooa shoots (EEBBS) was prepared by percolation method. The extract was evaluated for hypolipidemic and antioxidative activities using 400mg/kg body weight per day in a high fat diet induced hyperlipidemia in rabbits. The results were analyzed using one way analysis of variance (ANOVA) followed by Bonferroni's multiple comparison test and compared to the normal control, experimental control and the standard drug groups.Atorvastatin at a dose of 2.1mg/kg body weight per day was administeres to the standaqrd group.The results were expressed as Mean ± Standard Error of Mean (SEM). Values with p<0.05 were considered significant. Results: Oral administration of EEBBS, the test group showed significant reduction in the serum levels of total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and significant increase in the high density lipoprotein cholesterol (HDL-C) when compared to the experimental control group. The test group also exhibited significantly elevated catalase and Superoxide dismutase (SOD) activities and significantly lower malondialdehyde (MDA) levels as compared to the experimental group. Similar results were also found in the standard drug group. Conclusion: The results of demonstrated that EEBBS possess significant antihyperlipidemic and antioxidant activities and hence could be a potential source of medication as adjuvant to the existing therapy for treatment of dyslipidemia.

IND-16

Antilithic activity of some herbal extracts on urinary type struvite crystals


Chauhan CK 1 , Joshi MJ 2 , Vaidya ADB 3

1 Government Science College, Gandhinagar, Gujarat, India, 2 Department of Physics,Crystal Growth Laboratory, Saurashtra University, Rajkot, Gujarat, India, 3 Kasturba Health Society, ICMR Advanced Center for Reverse Pharmacology in Traditional Medicine, Mumbai, Maharashtra, India

Objectives: Struvite, (NH 4 )MgPO 4 .6(H 2 O), calculi can grow rapidly forming "staghorn-calculi", a more painful urological disorder with life-threatening complications. Epidemiological studies report its frequency of occurrence between 25 % and 38 %. Though, the surgical and ESWL management is popular, the medical prevention of recurrent struvite calculi is desirable and the need is to discover such drugs, which can inhibit struvite growth, in addition to high success rates, excellent safety profile and low side effect profile. Materials and Methods: In vitro growth- inhibition of struvite using herbal extracts of Boerhaavia diffusa Linn, Commiphora wightii and Rotula aquatica Lour. was studied by single diffusion gel growth technique. An aqueous solution of ammonium dihydrogen phosphate of 0.5 M concentration was mixed with the sodium metasilicate solution of specific gravity of 1.05 in appropriate amount to set the pH value 7.0. After the gelation took place, 20 mL supernatant solutions of pure 1.0 M magnesium acetate (control solution), and 1.0 M magnesium acetate prepared with 0.5% and 1.0% concentrations of the each of the herbal extracts were poured on the set gels in test tubes. Results: The number of grown struvite crystals and their dimensions, total mass, total volume and growth rate decreased with the increasing concentrations of each herbal extract. The enhancement of dissolution rate and fragmentation of crystals were also noticed. Conclusions: All herbal extracts are having antilithic activity and proved as potent inhibitors for struvite crystals. These results are important from the reverse pharmacology point of view.

CEL

CEL-1

Inhibition by Tadalafil of Contractility of Isolated Nonpregnant Human Myometrium


Sumalya Sen, Saibal Das, Blessed Winston, Abraham Peedicayil, Jacob Peedicayil

Christian Medical College, Vellore, Tamil Nadu, India

Objectives: It is well established that tadalafil inhibits phosphodiesterase-5 (PDE-5) leading to increased cellular levels of cGMP. Tadalafil has been shown to relax various isolated smooth muscles. However, its effect on human myometrium has not been determined. Hence, the study was conducted to determine whether tadalafil inhibits the potassium chloride (KCl)-induced contractility of isolated non-pregnant human myometrium, and if so, to study the probable mechanism of action involved. Materials and Methods: Myometrial tissue was obtained from 11 patients who underwent hysterectomy. The effect of tadalafil on 55 mM KCl induced contractility of isolated non-pregnant human myometrium was studied using a physiograph. The ability of the specific calcium-sensitive potassium (BKCa) channel blocker iberiotoxin (100 nM) to reverse the inhibitory effect of 40 μM tadalafil on KCl induced myometrial contractility was also studied. The percent inhibition caused by tadalafil with and without the iberiotoxin was calculated and statistically analyzed using the Wilcoxon signed-rank test in 'R' program (3.1.1). Results: Tadalafil produced a statistically significant inhibition of KCl induced myometrial contractility. The inhibition of 40 μM tadalafil on myometrial contractility was totally and significantly reversed by the concurrent administration of iberiotoxin. Conclusion: These results suggest that tadalafil inhibits the contractility of isolated non-pregnant human myometrium. The results also suggest that tadalafil does so by opening BKCa channels. Hence tadalafil could possibly be evaluated for use as a uterine relaxant for the management of clinical conditions like preterm labor that require myometrial relaxation.

CEL-2

In vitro Cytotoxic Activity of DNA of E. Coli and Celecoxib


Pracheta Sengupta, Gaurang B Shah, Palak Shah

Department of Pharmacology, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India

Objectives: Determination of anti-cancer activity of TLR-9 agonist (E. coli's DNA) and COX-2 inhibitor (celecoxib) alone and in combination with paclitaxal, cisplatin and vinblastine. Materials and Methods: IC 50 value of each compound was determined using MTT Assay. The anti-cancer activity was determined for both the cell lines when IC 30 of standard drugs was co-incubated with IC 20 of E. coli's DNA and celecoxib. Results: IC 50 values obtained for A549 cell lines were E. coli's DNA (8.9 μg/ml); Celecoxib (96.91 μM) and for Hep G 2 cell lines, E. coli's DNA (7.5 μg/ml); Celecoxib (129.68 μM). Cytotoxicity is significantly higher when standard compounds were given in combination with E. coli's DNA, but showed reduced effect when combined with celecoxib. Drugs when co-incubated with E. coli's DNA and celecoxib, the cytotoxicity were lower than that of the individual drugs. Conclusion: E. coli's DNA showed cytotoxic effect alone as well as in combination with the other cytotoxic drugs mediated probably through TLR-9 pathway. Celecoxib showed cytotoxic effect when given alone, but reduces the effect of other agents.

NEU

NEU-1

Hypertension a Risk Factor for Memory Impairment: Protection by ACE Inhibition


Rakesh Shukla

Department of Pharmacology, Council for Scientific and Insdustrial Research, Lucknow, Uttar Pradesh, India

Clinical observations have indicated a positive correlation between cognitive decline and hypertension. We have demonstrated that hypertension renders the brain susceptible to memory impairment due to chronic neuroinflammation induced by repeated Lipopolysaccharide (LPS) administration (25 μg, ICV) on day 1, 4, 7 and 10 in spontaneously hypertensive rats (SHRs) but not in normotensive wistar rats (NWRs). We also showed that control SHRs exhibited exaggerated angiotensin converting enzyme (ACE) activity and expression, increased neuroinflammation, oxidative stress and β-secretases (BACE) expression without Aβ1-42 deposition in the brain. Chronic neuroinflammation induced by LPS further amplified the ROS generation and expression of BACE, Aβ1-42 deposition and memory impairment along with endothelial dysfunction, CBF reduction and increased RAGE expression and ERK1/2 activation in SHRs. In addition, we showed that perindopril (ACE inhibitor), at non-antihypertensive dose (0.1 mg/kg, p.o. x 15 days) prevented memory impairment by reducing oxidative stress, endothelial dysfunction, RAGE activation and amyloidogenesis in SHRs. This shows that central angiotensin system influences memory independent of the blood pressure modulating effect. Thus, we propose that ACE inhibitors might be useful as a therapeutic strategy to enhance neuroprotection particularly in reference to memory dysfunction in hypertensive subjects.

NEU-2

A Comparitive Study on Efficacy of Zotepine and Quetiapine in Psychotic Patients in Government Hospital for Mental Care, Visakhapatnam


Venkata Subba Reddy Avula 1 , Gayatri Chavala 2 , Shovan Padhy 1 , Mahesh Reddy Avula 3 , Sudha J 1

1 Department of Pharmacology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India, 2 Department of Clinical Pharmacology and Therapeutics, NIMS, Hyderabad, Andhra Pradesh, India, 3 Department of Veterinary Pharmacology, NTR College of Veterinary Science, Gannavaram, Andhra Pradesh, India

Objectives: Zotepine is an antipsychotic agent and primary use of zotepine is for treatment for schizophrenia and as anti-maniac agent in patients with acute bipolar mania. Zotepine is claimed to be effective for positive and negative symptoms compared to quetiapine. The present study examined the efficacy of zotepine versus quetiapine. To assess the efficacy of zotepine versus quetiapine as an anti-psychotic agent. Materials and Methods: After getting IEC approval, Patients were selected randomly and informed consent taken from patients. This was a prospective, randomized, comparative study conducted for a period of 6 months. 90 patients were included in the study. 45 patients were prescribed zotepine and other 45 patients were prescribed quetiapine. Assessment of improvement in symptoms and adverse effects like sedation, extra pyramidal symptoms, weight gain were obtained using efficacy parameters at starting of study and during follow up visits which were scheduled every two weeks and at the end of the study. Efficacy parameters include PANSS scale, Young`s mania rating scale (YMRS) and Simpson angus neurologic rating scale (SANRS). A "p" value < 0.05 was considered significant. Results: The results obtained were tabulated and data was analyzed using SPSS version 11.5. Descriptive statistics were used for analysis. Using PANSS the group with zotepine has shown improvement in symptoms two months earlier when compared to the group with quetiapine. Remission rates occurred earlier with zotepine. YMRS improved 1 ½ week earlier in patients with zotepine. Zotepine has better efficacy when compared to quetiapine in treatment of psychotic disorders. Sedation was more with zotepine whereas EPS and weight gain are less with zotepine when compared to quetiapine. Conclusion: From this our objective that "zotepine has a good treatment efficacy compared to quetiapine in treatment of psychotic disorders" is proved.

NEU-3

Neuroprotective Potential of Selective and Nonselective COX-2 Inhibitors Against Ischemic Stroke Induced Complications


Varun Gupta, Vaibhav Gaur, Anil Kumar

Division of Pharmacology, University Institute of Pharmaceutical Sciences, UGC Center of Advanced Study, Panjab University, Chandigarh, India

Objectives: The aim of the present study was to investigate the effects of celecoxib (a selective cyclo-oxygenase-2 (COX-2) inhibitor), nimesulide (a preferential COX-2 inhibitor), and ibuprofen (a nonselective COX-2 inhibitor) against bilateral common carotid artery occlusion (BCCAO)-induced memory dysfunction, neuroinflammation and oxidative damage. Materials and Methods: Male Wistar rats (250-300 g) were exposed to bilateral common carotid artery occlusion (BCCAO) for 30 minutes, followed by 24-hour reperfusion. All drugs were administered for 7 days prior to BCCAO which was done on day 8. Various neurobehavioral parameters followed by biochemical studies were done and inflammatory markers were assessed. Results: BCCAO significantly shortened the fall-of time in the hanging wire experimental test and delayed transfer latency in the plus-maze performance task. Besides significant alterations in glutathione defense (i.e., glutathione S-transferase and redox ratio), increased acetylcholinesterase activity and pro-inflammatory marker (tumor necrosis factor alpha TNF-α) in the hippocampus was seen. Seven days of treatment with celecoxib (3 and 10 mg/kg, p.o.), nimesulide (10 mg/kg, p.o.) and ibuprofen (30 mg/kg, p.o.) significantly improved behavioral alterations & glutathione defense, and also attenuated acetylcholinesterase activity & TNF-α levels, as compared to control (i.e. ischemia reperfusion) group. Conclusion: The present study highlights the neuroprotective effect of celecoxib and nimesulide against ischemic stroke induced memory dysfunction, neuroinflammation and oxidative damage.

NEU-4

Omega-3 Fatty Acids Versus 5-hydroxytryptophan as Add on Therapy in Patients with Depression: A Comparative Study


Sahoo JP 1 , Singh Jarnail 1 , Khurana H 2 , Singh P 2

1 Department of Pharmacology, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 2 Department of Psychiatry Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India

Objectives: To evaluate the efficacy and safety of omega-3 fatty acids versus 5-hydroxytryptophan as add on to sertraline in patients with depressive illness. Materials and Methods: A prospective, open label, randomized, parallel group study was conducted on 90 treatment naïve depressive patients (18-65 years age). They were divided into 3 groups (n = 30). Group I: Sertraline 50 mg, Group II: Sertraline 50 mg plus omega-3 fatty acids 1 gm, Group III: Sertraline 50 mg plus 5-hydroxytryptophan 100 mg. Subjects were evaluated at weeks 0, 4 and 8 using Hamilton's Depression Rating Scale (HDRS), Beck's Depression Inventory (BDI) and Clinical Global Impression (CGI). Data were analyzed using repeated measures ANOVA (SPSS version 20.0). Post hoc analysis was also done. Results: Out of 90 patients, 42 were male and 48 were female. Mean age of all patients was 33.78 ± 8.34 years. Baseline parameters in patients of all groups were comparable. Addition of omega-3 fatty acids to sertraline showed significant reduction in HDRS, BDI and CGI scores (p value < 0.05) as compared to 5-hydroxytryptophan. All the three drugs were generally well tolerated with mild adverse effects, eg. nausea, vomiting, GI upset, headache, alteration of taste, sedation, drowsiness, palpitation, etc. Conclusion: Omega-3 fatty acids as add on to sertraline produces significant anti-depressant effects in depressive patients than 5-hydroxytryptophan.

NEU-5

Possible Involvement of Caveolin-1 in Progression of Alzheimer's Disease Through Activation of β-secretase in ICV-STZ Rat Model


Arnav Gautam, Ankita Gupta, Rohit Goyal

School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives: The present study was designed to investigate the role of caveolin-1 in progression of Alzheimer's type of dementia using intracerebroventricular streptozotocin (ICV-STZ) model in Wistar rats, possibly through dysregulation of Aβ. Materials and Methods: Male Wistar albino rats (220-260 g), n = 8 were clustered in six different groups: Normal, Sham, STZ control, daidzein (0.2 mg/kg, s.c.), daidzein (0.6 mg/kg s.c.) and minoxidil (0.45 mg/kg, i.p.). ICV-STZ was administered on first day of the protocol, low and high doses of daidzein were administered daily and minoxidil was administered on alternative days for 28 days. Impairments in cognition, memory consolidation and retention were assessed using morris water maze, elevated plus maze and balance beam test. The biochemical estimations for oxidative stress i.e. lipid peroxidation and glutathione were made in rat brain homogenate on final day of protocol. Statistical analysis was carried out using Graph Pad Prism 5. Results: ICV-STZ treated animals exhibited memory deficits in morris water maze, elevated plus maze and balance beam. Administration of low and high doses of daidzein produced significant restoration of memory dysfunctions. Minoxidil however caused moderate impairment in memory functions. Biochemical estimations of thiobarbituric acid reactive substances and glutathione levels in brain revealed a similar trend. Conclusion: The findings of the present study revealed that caveolin plays pivotal role in progression of Alzheimer's type of dementia in ICV-STZ treated animals. This may resemble the clinical conditions of AD resulting from chronic misfolding and aggregation of Aβ.

NEU-6

A Double Blind Randomized Placebo Controlled Study of Mirtazapine 7.5 mg Once Daily in Patients of Major Depressive Disorders on Escitalopram 10 mg Daily


Mallikarjuna Rao I, Usha Kiran Prayaga, Dharma Rao Uppada, Siva Prasad KV, Ramachandra Rao E

Department of Pharmacology, RMC, Kakinada, Andhra Pradesh, India

Objectives: Depression is ranked as the 4 th leading cause of disease burden globally. Escitalopram belongs to the class selective serotonin reuptake inhibitors (SSRIs), which is being widely used as first line therapy for all types of depression. Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA). It increases the release of both noradrenaline and serotonin by acting as an antagonist at central pre-synaptic alpha (2) receptors. Monotherapy with Mirtazapine is not proved to be to evaluate the efficacy and safety of low dose mirtazapine as add on therapy among Major Depressive Disorder (MDD) patients who are on escitalopram monotherapy. Materials and Methods: This is a prospective, double blinded, comparative, randomized, placebo controlled, parallel group study. In this study 22 participants received oral form of mirtazapine 7.5 mg + Escitalopram 10 mg and 23 received Escitalopram 10 mg + placebo. Participants were evaluated at baseline, 1 st , 2 nd , 4 th and 6 th week. Results: Both groups attained remission at 4 th week but there is significant difference between the two groups at 4 th and 6 th week. On Hamilton Depression Rating Scale (HDRS), P value is 0.02 and on Montgomery and Asberg depression rating scale (MADRS) it is < 0.001 at 4 th week whereas at 6 th week it is highly significant with P value < 0.001 on both HDRS and MADRS scales. Conclusion: Adding low dose mirtazapine has shown better efficacy in getting remission earlier, and improvement in sleep pattern compared with escitalopram monotherapy in MDD patients.

NEU-7

Role of Neurokinin Type 1 Receptor in Nociception at the Periphery and the Spinal Level in the Rat


Subrata Basu Ray, Reeta KH

Department of Anatomy and Pharmacology, All India Institute of Medical Sciences, New Delhi, India

Objectives: Noxious stimuli result in the release of substance P (SP) from the central terminals of the dorsal root ganglia neurons. SP binds predominantly to the neurokinin type 1 receptor and sensitizes the dorsal horn neurons in the spinal cord. SP is also released from the peripheral terminals leading to neurogenic inflammation. However, their individual contribution at the central and peripheral levels to postincisional nociception has not been delineated as yet. Materials and Methods: Sprague-Dawley rats were administered a selective NK1 receptor antagonist (L760735; 3-100 mcg) by preemptive intrathecal (i.t.) route. Nociception (guarding pain, mechanical allodynia and thermal hyperalgesia) following hind paw incision was evaluated. Based upon the results, the 30 mcg dose was selected for further study. This was administered intrawound (i.w.) and also by a combination of both i.t. and i.w. routes. In this part, the i.t. drug treatment was either preemptive or postemptive. Expression of SP in the spinal cord and the periphery was examined by immunohistochemistry, western blot and ELISA respectively. Results: Preemptive i.t. administration significantly attenuated pain behavior, particularly guarding. Guarding, which likely represents pain-at-rest, was alone decreased after i.w. drug treatment. Combined drug administration further attenuated postincisional nociception, more so after postemptive treatment. Expression of SP in the spinal cord decreased post-incision but increased in the paw tissue. Conclusion : In conclusion, SP acting through NK1r appears to be an important mediator of nociception, more so at the spinal level. These findings could have clinical relevance in postoperative pain.

NEU-8

Possible Role of Hedgehog-gli Signaling In-vivo in Neurodegeneration Induced by 3-Itropropanoic Acid


Anchal, Gargi, Rohit Goyal

School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives: Neurodegeneration is the term used for progressive loss in function and structure of neurons, including neuronal death in various disorders like Alzheimer's, Parkinson's etc. Hedgehog Gli paracrine signaling plays important role in cell proliferation and differentiation during development of embryo. N-(4-Hydroxy phenenthyl)-2-chlorobenzamide (SUBMS-004), a hedgehog agonist was reported to increase the expression of cyclin D1 and Gli protein in-vitro. Materials and Methods: Neuronal revival activity of the Hedgehog agonist at dose levels 5 and 10 mg/kg body weight was evaluated in 3-NP treated rats. Wistar rats (180-220 g) were divided into 4 groups (n = 5). Saline treatment was given to the control group and 3-NP (10 mg/kg i.p.) was administered to 3-NP control group animals for 7 days. Test drugs: SUBMS 004 (low and high doses) was given to the different test groups. Behavioral assessments were done using morris water maze, elevated plus maze and balance beam models. On the day of completion of experimental protocol, the animals were sacrificed; brain was isolated and homogenized for further biochemical determinations like malondialdehyde, nitric oxide and glutathione. m-RNA expression levels were also determined. Results: Administration of 3-NP showed significant increase in behavioral assessments, and decrease in scores in motor coordination test, as compared to control untreated rats. SUBMS-004 significantly restored the effects caused due to 3-NP. The similar results have been observed in tissue biochemical estimations. Conclusion: In present study, SUBMS004 (a Hedgehog agonist) enhanced cellular proliferation, maintained tissue repair process, as evidenced by the restoration of learning memory and coordination in rats.

NEU-9

Effect of Polyherbal Extract on the Alcohol Deprivation Effects Following Long Term Voluntary Alcohol Consumption in Rats


Lalit sharma 1 , Girdharilal Gupta 2

1 Jaypee University of Information Technology, Waknaghat, Solan, Himachal Pradesh, India, 2 Department of Pharmacology, SPPSPTM, SVKM'S NMIMS University, Mumbai, Maharashtra, India

Objectives: Alcohol abuse is a major problem worldwide and it affects people economy and health. Alcohol withdrawal syndrome is a group of disorders that appear after chronic alcohol intake. The present investigation was designed to explore the effect of a polyherbal extract in alcohol deprivation effects following long term voluntary alcohol consumption in rats. Materials and Methods: Polyherbal extract was prepared using hydroalcoholic extracts of Centella asiatica, Bacopa monnieri, Hypericum perforatum, Withania somnifera, Oscimum sanctum and Camellia sinensis in the ratio of (2:2:1:2: 2:1), respectively. Young healthy male Wistar rats (200-240 g) were allowed to voluntary intake of ethanol (day 1:4.5%v/v, day 2:7.5%v/v, day 3-15: 9%v/v) for 15 days. The behavioral assessments were done using elevated plus maze, light-dark model, tail suspension test, forced swim test and actophotometer on 16 th , 17 th & 18 th day and peak ethanol withdrawal symptoms were measured. The vehicle, polyherbal extract (20, 50 & 100 mg/kg, p.o.) and standard drug diazepam (2 mg/kg, i.p) were administered on peak withdrawal symptoms. Biochemical parameters like SGPT, SGOT, GGT and serum alkaline phosphatase were also determined. Results: Polyherbal extract showed significant protective effect in alcohol withdrawal anxiety, depression and seizures at all the doses 20, 50 & 100 mg/kg. Biochemical parameters studies also showed that polyherbal extract decreased the elevated levels of SGPT and SGOT and also maintained the levels of GGT and serum alkaline phosphatase. Conclusion : The results from the present study suggest the potential use of polyherbal extract in alcohol deprivation effects.

NEU-10

Evaluation of Effect of Flunarizine on Memory Function by Using Step Down Passive Avoidance Test in Albino Rats


Vinod Shinde, Radha Yegnanarayan, Khyati Doshi, Akhil Agarwal

Smt. Kashibai Navale Medical College and General Hospital, Narhe, Pune, Maharashtra, India

Objectives: Aim of the study was to evaluate effect of flunarizine on memory by using step down passive avoidance test in albino rats. Materials and Methods: The study approved by Institutional Animal Ethics Committee was conducted using 24 adult albino rats (n = 6 in each group). Effect of normal saline (0.1 ml/100 g), fluoxetine (10 mg/kg, intraperitoneally [ip]), and flunarizine (2 and 10 mg/kg, ip) on memory retrieval in rats was evaluated by using Step down passive avoidance test described by Vignisse et al. One day prior to conducting the test, each rat was trained to stay on central shock free zone platform (SFZ) for at least 90s. For this animals were applied shock of 15s every time when the rat stepped down placing all the paws on the grid floor. On the consecutive day retention of the memory was tested thirty minutes after administration of all test drugs. Step down latency (SDL) and number of mistakes was observed for a period of 5 min in all rats individually. The data was analyzed by one-way analysis of variance (ANOVA) and Student's t-test and P < 0.05 was considered significant. Results: Mean Step down latency was significantly increased in fluoxetine (10 mg/kg, i.p) group as compared to the normal saline (P < 0.05). SDL was increased in flunarizine (10 mg/kg, i.p) group but it was not statistically significant (P > 0.05). Number of mistakes were reduced in both fluoxetine and flunarizine (10 mg/kg, i.p) group and was statistically significant when compared to vehicle treated group. Conclusion: The results of the present study indicate beneficial effects of flunarizine in memory retrieval.

NEU-11

Neuroleptic Malignant Syndrome: A Rare Case Presentation


Baikan Saiteja Yadav, Vasudha Bakshi, Samyuktha Bharadwaj, Parbir Kumar Roy

School of Pharmacy, Anurag Group of Institutions, Ghatkesar, Hyderabad, Telangana, India

Objectives: Identification, analysis and management of patient with neuroleptic malignant syndrome. Mr. ABC a 68 yr old male patient presented with the complaints of shortness of breath and multiple episodes of coffee ground vomiting and cough since 3 to 4 days. History of disoriented and irritable presentation for 20 days and was on a psychiatric therapy (RIVAMER, ADVENTA, QUETIPINE) more than 7 years. Cns Motor System - drowsy, unresponsiveness, unaroussable. Patient is previously diagnosed with diabetes mellitus 2/hypertension/coronary artery disease with suggestive plan of percutanious transluminal coronary angioplasty/old cerebro vascular arrest right thalamus bleed with intravenous extension, esophagitis with duodenal ulcer/hiatial hernia/chronic kidney disease. Patient is suspected to be diagnosed with NMS based on the symptoms, investigations and lab reports. NMS is a neurological disorder most often caused be adverse reaction to neuroleptic or antipsychotic drugs. Patient is positive with symptoms of the NMS with high muscle rigidity, fever, autonomic instability, cognitive changes and increased plasma creatinine phosphokinase with 653 U/L which is much higher than normal (55-170 U/L). Results: Patient is kept under observation and treatment for associated co morbidities along with bromocreptin and baclofen for NMS is being carried and the therapy for NMS has shown mild improvement in sensorium and rigidity. Conclusion: Management of NMS a rare ADR of psychiatric therapy in a co-morbid patient is evaluated and the response of syndrome to the therapy is studied.

NEU-12

Anticonvulsnat Activity of Novel Synthesized 4-oxo-2-phenylquinazoline-3-(4h) Derivatives


Nimisha Jain, Swadesh Nayak, Prashant Vishwakarma, Pradeep Kumar Singour

Department of Pharmaceutical Chemistry, Computational and Synthetic Chemistry Division, VNS Institute of Pharmacy, Neelbud, Bhopal, Madhya Pradesh, India

Objectives: Epilepsy is a chronic and often progressive disorder characterized by recurrent transient attacks which are caused by an abnormal discharge of cerebral neurons. The objective of study was to investigate the novel molecules as anticonvulsants by synthesis of some 4-Oxo-2-Phenylquinazoline-3-(4H) derivatives. Materials and Methods: Total eight compounds were synthesized; anticonvulsant activities of synthesized 4-oxo-2-phenylquinazoline-3-(4H) derivatives have been performed by using standard maximal electroshock (MES) and subcutaneous pentylenetetrazole (scPTZ) induced seizure model in wistar rats. The animals were divided into 10 different groups and each groups having 6 animals. Phenytoin was used as reference drug. Rotarod apparatus was used for the determination of neurotoxicity. Results: The structures of the compound have been confirmed by spectral analysis. The majority of the compounds were found active in the anticonvulsant screening, out of these compounds N-(4-hydroxybenzylidene)-4-oxo-2-phenylquinazoline-3(4H)-carboxamide and N-(4-hydroxybenzylidene)-4-oxo-2-phenylquinazoline-3(4H)-carbothioamide possess potent anticonvulsant activity. Not one of the selected compounds demonstrated any sign of neurotoxicity. Conclusion: In this study, a new series of quinazolinone derivatives were synthesized and their anticonvulsant activity was determined. The proposed work is to effort towards the development and identification of novel molecules as anticonvulsant agents by synthesis of some novel quinazolinone derivatives with improved biological activity.

NEU-13

Evaluation and Comparison of the Cognition and Memory Enhancing Effect of Citalopram and Venlafaxine in Experimental Animals


Bidyut Banerjee, Babul Kr Bezbaruah

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objectives: To compare and evaluate the cognition and memory enhancing effect of citalopram and venlafaxine in experimental animals. Materials and Methods: The experiment was conducted in swiss albino mice. The animals were divided in five groups and Morris water maze was used. Cognition was impaired with scopolamine and piracetam was taken as the standard drug. The drugs were administered intra peritoneally. Escape latency and time spent in target quadrant was noted. Acetylcholinesterase level and GSH levels in the brain was estimated using spectrophotometer. The data was analyzed using graph pad prism 5.01 software. Results: The mean escape latency in the venlafaxine group on the 4 th day of training was 58.292 ± 1.713 and in the citalopram group was 60.792 ± 1.823. The time spent in target quadrant on day 15 and 18 in the venlafaxine group was 60.000 ± 1.065 and 58.167 ± 1.214 and in the citalopram group was 60.208 ± 1.011 and 56.583 ± 1.145 respectively. The AChE level in the venlafaxine and citalopram group was 147.214 ± 1.145 and 150.763 ± 1.512 and brain GSH levels were 27.543 ± 11,923 and 24.124 ± 1.123 respectively. Both the groups had significant increase in the time spent in target quadrant and decreased AChE levels in brain and increased GSH levels when compared to the cognition control group. Conclusion: This study shows that although both venlafaxine and citalopram improves memory and cognition but venlafaxine is superior to citalopram in this aspect.

NEU-14

(+)-Catechin is Protective Against Pentylenetetrazole-induced Seizures and Seizure-induced Cognitive Impairment in Rats


Reeta KH, Sunil Kumar, Prabhakar P, Gupta YK

Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India

Objectives: To evaluate the effect of (+)-catechin, a type of natural phenol and antioxidant, against pentylenetetrazole (PTZ)-induced seizures and seizure-induced cognitive impairment in rats. Materials and Methods: The study was approved by the Institutional Animal Ethics Committee, AIIMS, New Delhi. Male Wistar rats (200-225 g) were randomly divided into six groups: Control; PTZ; three doses of (+)-catechin (15, 30 and 60 mg/kg once a day, p.o); valproate (300 mg/kg, i.p) which was used a standard. Normal saline was given as vehicle. Drugs/vehicle was administered for 28 days. PTZ (60 mg/kg, i.p.) was administered on day 28. Cognitive impairment was assessed using a battery of behavioral tests - Morris water maze (MWM), elevated plus maze (EPM) and passive avoidance (PAT) tests. Results: Pre-treatment with (+)-catechin delayed the onset of myoclonic jerks as well as generalized tonic clonic seizures (GTCS), however it was significant only at the 60 mg/kg dose. The duration of GTCS was also decreased with (+)-catechin pretreatment. PTZ caused significant cognitive impairment as shown by increase in the latency to enter and decrease in the time spent in the target quadrant in MWM test; significant increase in retention transfer latency in EPM as well as significant decrease in the retention latency in PAT as compared to the control group. These changes in the behavioral paradigm were prevented by pretreatment with (+)-catechin (60 mg/kg). Conclusion: This study shows that (+)-catechin is protective against PTZ-induced seizures and seizure-induced cognitive impairment in rats.

NEU-15

Neurophrmacological Evaluation of Methanolic Extract of Lagenaria Siceraria (Molina) Standley Fruits


Rakesh Prajapati 1 , Sachin Parmar 2

1 Bhagwan Mahavir College of Pharmacy, Surat, Gujarat, India, 2 Department of Pharmaceutical Sciences, Saurashtra University, Rajkot, Gujarat, India

Objectives: The purpose of the study was to evaluate the neuropharmacological activities of methanolic extract of Lagenaria siceraria (Molina) Standley fruits (MLSF) using several experimental (animal behavioral) models. Materials and Methods: Adult Wistar albino rats were subjected to behavior despair and elevated plus maze (EPM) tests. Thiopental-induced sedation and rotarod tests were conducted on Swiss albino mice. Results: The effects of MLSF on anxiety, depression, thiopental-induced sleeping time, and rotarod performance were evaluated. The anxiolytic activity of MLSF (100, 200 and 400 mg/kg) per os (p.o.) was characterized by increased time spent and number of entries in open arms in the EPM paradigm as compared to control group (p < 0.001). The MLSF (50, 100, and 200 mg/kg, p.o.) showed dose-dependent significant reduction in duration of immobility (p < 0.01) in behavior despair test. The MLSF at the doses 50 and 100 mg/kg, i.p. was found to produce a significant reduction in motor coordination (p < 0.001) and prolongation of thiopental-induced sleeping time (p < 0.001). The phytochemical screening revealed the presence of flavonoids, saponins and sterols in fruits. Conclusions: The results of the study for the first time show that the plant possesses anxiolytic, antidepressant and sedative like activities confirming the traditional claims. Future research should focus on the isolation and identification of the phytoconstituents responsible for activities of LS.

NEU-16

Evaluation of Neuroprotective Activity of Piper Nigrum Reperfusion Induced Oxidative Stress


Pravin Tirgar, Patel Milan Narayanbhai, Desai TR

School of Pharmacy, RK University, Rajkot, Gujarat, India

Objectives: Stroke is a life-threatening disease characterized by rapidly developing clinical signs of focal or global ischemia. It is the third leading cause of death. It causes two lakhs death each year and are major cause of disability. A number of flavonoids have beenshown to attenuate the cerebral ischemic reperfusion injury in animal models. Piperine, a flavonoid of Piper nigrum, possesses multiple pharmacological properties. This study aimed to investigate whether Piper nigrum modulated the cerebral injury induced by bilateral common carotid artery occlusion (BCCAO) in rat. Materials and Methods: In the present study, number of parameters were estimated including glutathione (GSH), catalase (CAT), superoxide dismutase (SOD), lipid peroxidation (LPO), brain protein and calcium level in brain homogenate as markers to assess the severity of oxidative stress and subsequent protection by P. nigrum. Histopathology studies and cerebral infarction area were used to assess the protection against ischemic/reperfusion induced oxidative stress in P. Nigrum treated groups and quercetin. Results: In our study, there was significant increase in levels of SOD, CAT, GSH and brain protein while decreased level of LPO and calcium in P. nigrum and quercetin treated groups, which confirm the protection against brain damage. Study revealed that protection by P. Nigrum was slightly lower compared to quercetin. Conclusion: From these results we conclude that P. nigrum may have potent neuroprotective action against the global cerebral ischemic/reperfusion induced oxidative damage in brain.

NEU-17

Modulation of Dopamine D2 Signalling in Alcohol Induced Neuropathic Pain in Rats


Jyotsna, Shusheela Kumari, Rohit Goyal

Department of Pharmacology, School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives: Neuropathic pain is due to desensitization of neurons experienced as an unpleasant sensory response initiated in peripheral and central nervous system. Alcohol consumption is attributed with sensitisation of senory and motor neurons. Dopaminergic dysfunctiong has also been demonstrated in painful clinical conditions. The present study was designed to investigate the possible modulation of dopamine D2 signalling in alcohol induced neuropathic condition in rats. Materials and Methods: Wistar albino rats of either sex (180-220 g, n = 6) were employed in present study. Rats were pair fed with isocaloric liquid diets containing 30% of ethanol for 4 weeks. Chronic alcohol administration was reported to induce increased pain perception. Two weeks prior to initiating the experiment, rats were adapted to the liquid diet containing ethanol (upto 37% of caloric content) followed by daily drug treatment of metoclopramide, d2 receptor antagonist (1.25-2.5 mg/kg) and bromocriptine, d2 receptor agonist (2.5 mg/kg). The periodic assessment of neuropathic pain was carried out using hot plate, hot immersion and cold allodynia tests. Results: Chronic alcohol consumption caused activation of D2 signalling resulting increased pain perception characterized by decreased nociceptive threshold. Conclusion: The significant changes in oxidative stress and nitric oxide levels signifying damage of nerve fibres and release of inflammatory mediators respectively were also reported.

NEU-18

To Evaluate and Compare the Antiepileptic Effect of Calcium Channel Blockers and Their Ability to Potentiate the Antiepileptic Effect of Phenytoin in Rats


Vijayalaxmi Uppin, Wali RS, Naikawadi AA

Deparment of Phamrmacology, Shri B.M. Patil Medical College, BLDE University, Vijayapur, Karnataka, India

Objectives: To study the effect of calcium channel blockers (CCBs) nifedipine and verapamil on maximal electroshock (MES)-induced convulsions and also to evaluate their effect in combination with Phenytoin. Materials and Methods: For this study, male Wistar rats were used. Effects of nifedipine (5 mg/kg), verapamil (20 mg/kg) alone and in combination with phenytoin (25 mg/kg) were studied in MES model. Abolition of hind limb tonic extension and reduction of duration of tonic extension was considered as the index for antiepileptic activity in MES. Percentage protection was calculated and statistical analysis was carried out using t-test and ANOVA test. Results: Verapamil, nifedipine and produced significant antiepileptic effect alone. Verapamil and nifedipine potentiated the antiepileptic effect of phenytoin sodium. Conclusion: Dose of phenytoin sodium can be reduced in epileptic patients receiving verapamil or nifedipine for some other clinical conditions. Verapamil and nifedipine can also be used alone in the treatment of generalized tonic-clonic seizures. However, its further confirmation to establish clinical utility of calcium channel blockers.

CHM

CHM-1

Haematological Changes Due to Cancer Chemotherapy in Oncology Department of a Tertiary Care Teaching Hospital: A 6 Months Assessment


Lahon J 1,2 , Purnima Devi 1,2 , Wahlang JB 1,2 , Brahma KR 1,2 , Kumar R 1,2 , Nongkynrih BS 1,2

1 Department of Pharmacology, NEIGRIHMS, Mawdiangdiang, Shillong, Meghalaya, India, 2 Department of Oncology, NEIGRIHMS, Mawdiangdiang, Shillong, Meghalaya, India

Objectives: To find out the pattern of haematological changes due to cancer chemotherapy in oncology department, NEIGRIHMS. Materials and Methods: It is a hospital based prospective observational ongoing study to monitor adverse drug reactions (ADRs) associated with different drugs used in cancer chemotherapy in oncology department of NEIGRIHMS hospital. The study was started after obtaining due permission from the Institutional Ethics Committee, NEIGRIHMS. In this study we tried to highlight the cases presenting with haematological changes associated with chemotherapy within the first 6 months study period. Results: A total of 67 patients coming to the oncology department of NEIGRIHMS for chemotherapy have been taken and observed for possible adverse drug reactions (ADRs). The collected reports have been analyzed for haematological changes for causal association with the suspected drug/drugs. Other parameters like demographic profile of the patients and drug details have been also worked out. Out of these 67 cases, 21 cases (31%) presented with haematological changes suspected due to cancer chemotherapy. The pattern of the haematological changes includes anaemia, leucopenia, neutropenia, lymphopenia and others as observed during various chemotherapy cycles. The suspected drugs in most occasions were cisplatin, oxaliplatin, 5-FU, cyclophosphamide, doxorubicin, vincristine. The patients were managed by GM-CSF and other supportive measures. Conclusion: Haematological changes are one of the commonest and dreaded ADRs encountered during cancer chemotherapy. Timely and efficient management of these ADRs is beneficial to the patients and add to the success of the ongoing chemotherapy regimen.

CHM-2

Cisplatin Resistance Reversal by Disulfiram and Caffeine


Ashish Kadia, Gaurang Shah

Department of Pharmacology and Clinical Pharmacy, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar, Gujarat, India

Objectives: To study the effect of disulfiram and caffeine on cisplatin efficacy on normal and senescent A549 cells. Materials and Methods: A549 cell line was exposed to sub-IC 50 concentrations of cisplatin (1.66-16.66 μM) in increasing order to develop senescent cells (A549-R). The A549 and A549-R cells were exposed to different concentrations of cisplatin (0.83-50 μM) and disulfiram (0.067-0.202 μM) and their cytotoxic effects were measured using MTT assay. Both of cell types were pre-treated with caffeine (515 μM), disulfiram (0.101 μM) or both followed by cisplatin exposure. The cytotoxic effect in each case was determined and compared. Results: IC 50 of cisplatin and disulfiram on A549 cells were 15.14 μM and 0.101 μM respectively. The same in A549-R cells were 30.09 μM and 0.183 μM respectively. IC 50 of cisplatin in disulfiram (0.101 μM) pre-treated A549 and A549-R cells were 1.43 μM and 2.44 μM respectively. Similarly IC 50 of cisplatin in caffeine (515 μM) pre-treated normal and A549-R cells were 4.30 μM and 2.53 μM respectively. Pre-treatment with both disulfiram and caffeine followed by cisplatin treatment resulted into an IC 50 of 1.43 μM and 1.13 μM in A549 and A549-R cells respectively. Conclusion: Pre-treatment of disulfiram enhanced cytotoxicity and improved efficacy of cisplatin in both A549 and A549-R cells. Addition of caffeine in same resulted into further enhancement of cytotoxicity in A549-R but not in A549 cells.

CHM-3

Evaluation of Chemopreventive and Chemotherapeutic Effect of Berberine in Den Induced HCC in Partially Hepatectomized Rats


Manash Pr Borgohain 1 , Ahmed S 1 , Bolshette N 2 , Lahkar M 1

1 Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Guwahati, Assam, India, 2 Department of Biotechnology, National Institute of Pharmaceutical Education and Research, Guwahati, Assam, India

Objectives: Hepatocellular carcinoma (HCC) is the major form of primary malignancy of liver. The present study was designed to investigate the chemopreventive effect of berberine on diethyl nitrosamine (DEN) induced HCC after partial heaptectomy in rats promoted by 2-AAF. Materials and Methods: In injury promoted DEN model, the classical IKKβ-dependent NF-κB signaling pathway has been shown to play a crucial role in liver inflammatory responses by controlling the expression of an array of growth factors and cytokines. IL-6 exerts many of its effect via activation of STAT-3, an important transcription factor found to be involved in liver tumorigenesis. Results: Berberine effectively down-regulates hepatocyte (Kuffer cell) IL-6 and STAT-3 expressions by inhibiting NF-ƙB signaling pathway. In addition, it suppresses oxidative and nitrosative stress produced by DEN on rat hepatocytes. Furthermore, it also down-regulates hepatic expression of carcinoembrionic antigen (CEA), gamma-glutamyl transferase (GGT) and alpha fetoprotein (AFP). Conclusion: Inhibition of hepatocyte expression of TGF-α and c-myc in pre-treated group suggests chemopreventive effect of berberine against DEN induced hepatocarcinogenesis.

CHM-4

A Prospective Study of the Impact of Microbiological Cultures on Antibiotic Prescribing Pattern in a Tertiary Care Hospital


Vachhani PK, Singh AP

Department of Pharmacology, P.D.U. Govternment Medical College, Rajkot, Gujarat, India

Objectives: This study was undertaken to assess the impact of microbiological culture results on antibiotic prescribing pattern. Materials and Methods: This prospective observational study was conducted on 400 patients of either sex and any age with positive microbiological culture results. Empirical antibiotic therapy details were recorded and change in empirical antibiotic therapy after positive culture results was also recorded. Assessment of sensitivity resistance pattern of microorganisms was also done. Results: In the study, male: female ratio was 1.01:1. Majority of patients i.e. 94 (24.50%) were in 46 years to 60 years of age group. Definitive antibiotic therapy was initiated in 103 patients (25.75%) out of 400 patients. Highest number of change in antibiotic therapy was done in UTI (63.95%) and septicemia (32.61%) cases. Klebsiella (34.25%), E. coli (32%) and Staphylococcus aureus Scientific Name Search  (14.75%) were commonly isolated microorganisms. Cephalosporins (77.75%) and aminoglycosides (47%) were commonly used in empirical antibiotic therapy while nitrofurantoin (47.57%) and penicillins (22.33%) were commonly used in definitive antibiotic therapy. Definitive antibiotic therapy is associated with reduced duration of hospital stay as compared to empirical antibiotic therapy (p < 0.0001). Conclusion: Antibiotic prescribing is infrequently influenced by microbiological culture results. Adjustment of the antimicrobial therapy according to microbiological culture results can decrease the duration of hospital stay as well as can decrease the spread of antimicrobial resistance.

CHM-5

Evaluation of Antitumor and Anti-angiogenic Potential of Spondias Pinnata (L.f) Kurz Leaves


Nishitha Chandran KS, Litty Joseph, Srinivasan KK, Jyoti Harindran

Department of Pharmaceutical Sciences, Mahatma Gandhi University, Cheruvandoor Campus, Kottayam, Kerala, India

Objectives: Cancer is one of the most dreaded disease in which one or more cells in the body lose their normal growth-controlling mechanisms and continue to grow, causing the death of the host. Tumor survival and propagation dependent on angiogenesis. The use of inhibitors of angiogenesis can serve as promising agents in the treatment of cancer. Natural products are being used for treating various diseases without the risk of side effects. The major objective of the present study is to evaluate the anti tumor and antiangiogenic effect and to establish a possible mechanism of action of Spondias pinnata (L.f) Kurz leaves. Materials and Methods: The in vitro cytotoxic and antiproliferative activity of fractions of Spondias pinnata were done by Trypan blue dye exclusion method in EAC cells and MTTassay in MCF7 cells. Antitumor activity evaluated by treating the EAC induced liquid and solid tumor by the sample. RTPCR analysis used to reveal the effect of fraction on gene expression in tumor sample. Results: Ethylacetate fraction exhibited maximum cytotoxicity in EAC cells and MCF7 cells compared to aqueous fraction. Ascites tumor growth in Swiss albino mice inhibited by the ethylacetate fraction dose of 400 mg/kg, by increasing the life span and improving the haematological values. Fraction inhibits the growth of solid tumor confirmed by gene expression method. Expresion of VEGF, angiogenic factor in the tumor sample inhibited by ethylacetate fraction. Conclusion: Cytotoxic activity and tumor suppression in induced mice revealed the anticancer activity of the ethylacetate fraction of Spondias pinnata. Inhibition of the solid tumor growth and VEGF expression proves the antiangiogenic activity of the fraction.

CHM-6

Pattern of Adverse Drug Reactions of Antiretroviral Therapy in HIV Patients at a Tertiary Care Hospital


Prashant Maheshwari 1 , Pooja Agrawal 2 , Ambrish Gupta 1 , Priyadarshi BP 2 , Virendra Kushwaha 1 , Arpita singh 1

1 Department of Pharmacology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India, 2 Department of Internal Medicine, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India

Objectives: To study the pattern of ADRs occurring due to ART in HIV/AIDS patients. Materials and Methods: A prospective observational study was conducted over a period of one year at ART Centre, GSVM Medical College Kanpur. All HIV positive patients attending O.P.D. who encountered ADRs were enrolled in our study irrespective to their age and sex. Data was collected using ADR reporting form issued by Indian Pharmacopoeia Commission. Causality assessment was done by using Naranjo's Probability Scale. Modified Hartwig severity scale was used to evaluate severity, WHO criteria for seriousness and guidelines of council for international organizations of medical sciences to decide the predictability of ADRs. Results : Duringthe study period a total of 75 patients encountered ADRs due to ART. Among them 53.4% were male and 46.6% were female. Most common regimen responsible for ADRs was zidovudine/lamivudine/nevirapine (57.3%) followed by zidovudine/lamivudine/efavirenz (20%). Most common ADR was anemia (53%) followed by rash (12.3%). Causality assessment showed that most of ADRs were possible (72.8%) followed byprobable (27.2%). Maximum ADRswere foundmild (56.7%) followed by moderate (37%), severe (6%) on severity scale. Majority ofthe ADRs (81.5%) were non serious and most (95%) were predictable. Conclusion : Myriad ADRs are associated with ART. Most common ADR associated with ART was anemia in our study and most common regimen responsible was zidovudine/lamivudine/nevirapine. So this regimen should be given with caution with the direction that these patients should be monitored for haematological abnormalities especially anemia.

CHM-7

Clinical and Biochemical Evaluation of Adverse Drug Reaction of Chemoradiation on Oral Cavity and Oropharynx Cancer Patients in a Tertiary Care Hospital of Assam


Das Monami, Das Swarnamoni

Department of Pharmacology, Assam Medical College, Dibrugarh, Assam, India

Objectives: To assess the occurrence of ADR on chemoradiation in oral cavity and oropharynx cancer patients and to assess their casual relationship. To assess cisplatin and carboplatin induced changes in biochemical parameters. Materials and Methods : A prospective observational study was carried out for a period of 8 months from January 2015 to August 2015, after getting approval from human ethical committee, among the indoor patients who received chemoradiation in the Department of Radiotherapy, Assam Medical College and Hospital. The patients were followed up to track for ADR and changes in haematological parameters following chemoradiation. Results : Out of total 64 patients, 58 consented to participate in the study, while 51 patients completed the treatment. All the patients had developed one or more ADRs. Causality assessment revealed 87% of ADRs to be probable and 13% to be possible according to WHO Uppsala Monitoring Centre causality assessment scale. The ADRs that commonly occurred were alopecia, nausea, vomiting, anorexia, rise of temperature, peripheral tingling sensation, and tinnitus. Haematological parameters showed decrease in haemoglobin level, total leucocyte count, neutrophil count and platelet count after treatment. Renal function assessment showed rise in blood urea and serum creatinine with cisplatin and carboplatin, and returned to the baseline on 2 nd follow up. Conclusion: Cancer of oral cavity and oropharynx remains on the rise inspite of different health related awareness programmes. Our study focuses on the possible ADR of chemoradiation and thereby the need for better anticancer agents having better efficacy with fewer side effects.

PKN

PKN-1

Comparison of Isoniazid and Rifampicin Exposure Between Intermittent and Daily Anti-tubercular Regimen, in Children with Tuberculosis: An Interim Analysis


Jaya Ranjalkar 1 , Binu Susan Mathew 1 , Valsan Philip Verghese 2 , Anuradha Bose 2 , Winsley Rose 2 , Dulari Gupta 2 , Denise Fleming H 1

1 Department of Pharmacology and Clinical Pharmacology, Christian Medical College, Vellore, Tamil Nadu, India, 2 Department of Paediatrics, Christian Medical College, Vellore, Tamil Nadu, India

Objectives: This study compared the exposure of isoniazid and rifampicin in children receiving either intermittent or daily antitubercular regimen (ATT). Materials and Methods: Children aged 2 to 16 years initiated on either daily or intermittent (thrice weekly) ATT were recruited. Towards the end of intensive phase, blood specimens were collected pre-dose, followed by 0.5 hrs, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 4 hrs and 6 hrs post-dose. The concentrations of isoniazid and rifampicin were analysed using validated LC-MS/MS and HPLC assays, respectively. Results were analysed using non parametric methods with R-version 3.1.2. Results: The median dose (mg/kg) for isoniazid was 10.13 versus 8.10*, C 0 (μg/ml) was 0 versus 0.15* (p = 0.0009) and C max (μg/ml), C 2 (μg/ml), C 6 (μg/ml) were 6.8, 5.1 and 2.01 versus 6.86, 5.54 and 2.18* respectively. Median AUC 0-6hrs (mg.hr/L) was 22.18 versus 24.55*. The median dose (mg/kg) for rifampicin was 10.26 versus 10.77*, C 0 (μg/ml) was 0 versus 0.01* and the C max (μg/ml), C 2 (μg/ml), C 6 (μg/ml) were 6.19, 4.3, 1.01 versus 5.59, 4.4, 1.68* respectively. Median AUC 0-6hrs (mg.hr/L) was 16.87 versus 16.51*. All patients (except 2) had isoniazid C max above 3 μg/ml (recommended range: 3-6 μg/ml)**. 84% of the patients had rifampicin C max less than recommended range (8-24 μg/ml)**. C max correlated with AUC 0-6hrs in both regimens (r 2 = 0.889 and 0.97 for isoniazid; r 2 = 0.89 and 0.98 for rifampicin*. However, only 20% of the patients had C max at 2 hrs for both isoniazid and rifampicin. Conclusion: 84% of the patients had a C max rifampicin <8 μg/ml. The C max and AUC 0-6 h was not different for both drugs between daily and intermittent regimen.

PKN-2

Effect of Gymnema sylvestre on the Pharmacokinetics of Sitagliptin Phosphate in Type 2 Diabetes Mellitus


Bhutkar Shraddha, Lokegaonkar Dhanashree, Dhande Swati R, Kadam Vilasrao J

Bharati Vidyapeeth's College of Pharmacy, Belapur, Navi Mumbai, Maharashtra, India

Objectives: Practising complementary and alternative medicinal therapy has become a boom worldwide. There is a dearth in communication between the doctors and the patients regarding the concomitant use of complementary medicines like ayurvedic churnas, health tonics and other drugs of natural origin with allopathic drugs. This usage might magnify or oppose the effect of synthetic drug leading to interactions. The use of herbals along with allopathic treatment is inevitable in treatment of chronic diabetes which might lead to interaction. The present study was undertaken to evaluate pharmacokinetic interaction between commonly used herb Gymnema sylvestre and allopathic drug sitagliptin phosphate in streptozotocin and high fat diet-induced type II diabetes mellitus in rat model. Materials and Methods: Female Sprague Dawley rats were grouped into following groups. Group 1: Vehicle Control, Group 2: Disease Control, Group 3: sitagliptin phosphate (20 mg/kg), Group 4: Gymnema sylvestre (400 mg/kg), Group 5: sitagliptin phosphate (20 mg/kg) and Gymnema sylvestre (400 mg/kg). After giving proper treatment to the rats, blood samples were withdrawn at 0 th , 2 nd , 4 th , 8 th and 12 th hours on first day of treatment with sitagliptin phosphate and combination of sitagliptin phosphate with Gymnema sylvestre in order to check alteration in absorption parameter by determining the change in area under curve (AUC) of sitagliptin. Sitagliptin was extracted using a newly developed and validated HPTLC method. Results and Conclusion: It was found that AUC of STG gradually decreased in the presence of Gymnema sylvestre at given dose. Further studies need to be carried out at various other doses to evaluate possible interactions.

CLP

CLP-1

Evaluation of Hand Written and Computerized Out-patient Prescription in Urban Part of Central Gujarat


Anuradha Joshi 1 , Jatin Buch 2 , Nitin Kothari 3 , Nishal Shah 1

1 Department of Pharmacology, Pramukh Swami Medical College, Karamsad, Gujarat, India, 2 Gujarat Medical Education and Research Society Medical College, Gandhinagar Civil Hospital Campus, Gandhinagar, Gujarat, India, 3 Department of Pharmacology, Pacific Medical College and Hospital, Udaipur, Rajasthan, India

Objectives : To evaluate frequency and type of prescription errors in outpatient prescriptions and find whether prescription writing abides with WHO standards of prescription writing. Materials and Methods: A cross-sectional observational study was conducted at Anand city. Total 749 (549 handwritten and 200 computerised) prescriptions were collected from local pharmacy stores over a period of 6 months. Prescriptions were analysed for errors in standard information, according to WHO guide to good prescribing. Descriptive analysis was performed to estimate frequency and types of errors and expressed as total number of errors and percentage. Results: Abundant omission errors were identified in handwritten prescriptions e.g. OPD number was mentioned in 6.19%, patient's age was mentioned in 25.50%, gender in 17.30%, address in 0.73% and weight of patient mentioned in 11.29%, while in drug items only 2.97% drugs were prescribed by generic name. Route and Dosage form was mentioned in 77.35%-78.15%, dose mentioned in 47.25%, unit in 13.91%, regimens were mentioned in 72.93% while signa in 62.35%. Total 4384 errors out of 549 handwritten prescriptions and 501 errors out of 200 computerized prescriptions were found in clinicians and patient details. While in drug item details, total number of errors identified were 5015 and 621 in handwritten and computerized prescriptions respectively. Conclusion: As compared to handwritten prescriptions, computerized prescriptions appeared to be associated with relatively lower rates of error. Since out-patient prescription errors are abundant and often occult in handwritten prescriptions, prescribers need to adapt themselves to computerised prescription order entry in their daily practice.

CLP-2

An Evaluation of Adverse Drug Reactions Monitoring at a Pharmacovigilance Unit in Tertiary Care Hospital


Komal Halkai, Venkata Rao, Devika

Objectives: Evaluation of the incidence and the patterns of ADRs from the reports collected from various clinical departments of this hospital. Materials and Methods : A prospective hospital-based study over a period of six months (January 2015-june 2015) was carried out by the Department of Pharmacology under PvPI in Kamineni Institute of Medical Sciences. The ADRs of in-patient and outpatient were recorded. The data were subjected to descriptive analysis. The study plan included analysis and assessment of the clinical pattern, spectrum of ADRs reported based on causality, severity, preventability factors. Results : A total of 100 patients were included in study. Out of which 58% (34.81 ± 6.43) were females and 42% (35.47 ± 7.23) males. The most common drug group causing ADRs was antimicrobials (51%), followed by NSAID's (20%). The dermatological reactions (43%) were more, followed by gastrointestinal system (31%) and CNS (18%). Majority of ADR's were reported from OBG department (27%) followed by orthopaedics (24%). 87% of ADRs were non-serious, 13% were serious but recovered. As per WHO causality assessment 77% ADRs were probable and 23% possible. Conclusion : The clinical spectrum of ADRs ranged from the more common mild reactions such as skin rashes, itching, nausea, and vomiting to moderately severe reactions prolonging the hospital stay. The predominant causative drugs were antimicrobials, non-steroidal anti-inflammatory drugs. The majority of ADRs were probable/likely in causality assessment, moderate in severity and probably preventable. ADRs contribute to increased morbidity and mortality in patients; thereby pose a huge burden on the society.

CLP-3

Randomized Controlled Trial of Rectal Misoprostal and Intramuscular Oxytocin in the Prevention of PPH


Savitha A 1 , Sarita H 2 , Kashinath Gumma 1

1 Department of Pharmacology, BRIMS, Bidar, Karnataka, India, 2 Department of Obstetrics and Gynaecology, BRIMS, Bidar, Karnataka, India

Objectives: PPH accounts for merely 23% of maternal mortality in developing countries. Misoprostol is a uterotonic agent and is a PGE analogue commonly used in management of PPH. Oxytocin is another uterotonic agent which is now been introduced as intramuscularly effective agent to prevent PPH. This study aims to compare rectal misoprostol with intramuscular oxytocin in reducing blood loss in third stage of labor to prevent PPH. To compare the clinical effect of rectal misoprostol with intramuscular oxytocin in prevention of PPH. Materials and Methods: A randomized study was conducted over duration of 3 months, at department of OBG BRIMS, Bidar. Patients with singleton pregnancy with the history of one previous LSCS and opting for elective LSCS were included in the study. Patients with contraindications for use of either misoprostol or oxytocin, such as pre eclampsia, cardiac disease and asthma or grand multipara were excluded from the study. Immediately after spinal anaesthesia rectal misoprostol was given while oxytocin was administered after delivery of the baby. Incidence of PPH and amount of blood loss was observed and compared. Results: The difference in both the groups with regard to mean amount of blood loss, mean duration of the third stage of labor, and mean amount of fall in hemoglobin level was not statistically significant as P value was > 0.05. The incidence of PPH and the need for additional oxytocic are slightly more in the misoprostol group. The incidence of shivering and pyrexia was more in the misoprostol group, but not so disturbing so as to lead to disuse of this drug. Conclusion: Oral misoprostol, though not a replacement of parenterally administered oxytocin, can be used safely in all deliveries for the prevention of postpartum hemorrhage, especially in non-institutional deliveries and in places of low resource settings.

CLP-4

Adverse Drug Reaction Monitoring in a Tertiary Care Teaching Hospital


Drupad HS, Nagabushan H

Department of Pharmacology, Mandya Institute of Medical Sciences, Karnataka, India

Objectives: To assess and analyse adverse drug reactions (ADRs) according to reporting and presentation. To describe causality and severity analysis. Materials and Methods: After taking approval from the institutional ethical committee study was undertaken over a period of one year. A prospective observational study was conducted to monitor the ADRs in all the clinical departments and emergency units of the hospital. The ADRs forms were distributed to all the departments and informed all the staff members to report any suspected adverse drug reactions. ADRs were monitored both actively and passively. Reported forms were collected by active surveillance and Causality assessment was done by pharmacologist using Naranjo's & WHO scale and severity by Hartwig's scale respectively. Results: Total 85 ADRs were reported over a period of year. Most of the ADRs were reported from the ART centers 70.6%. There were 14.1% from department of Obstetrics and Gynecology and 9.4% cases from department of Medicine. The most common system involved in ADR was hematological system about 29.4% of overall reaction followed by 24.7% dermatological. Zidovudine induced anemia was the most common ADR. Causality assessed using Naranjo's scale showed that most of reported ADRs were probable 49.4%, 27.1% were doubtful and 23.5% were possible. Conclusion: Study showed that there was under reporting of ADRs. Most of the cases were reported from ART center. There is a need to improve awareness among the clinicians to emphasize their role in voluntary reporting of ADRs, on generating quality reports, critically monitor the ADRs so as to prevent them further.

CLP-5

Potential Drug-Drug Interactions in Critically Ill Patients in a Tertiary Care Hospital: A Prospective Study


Manjeeta Gupta, Aparna Chincholkar, Ranjit Wagh, Madhav Mautalik

Department of Pharmacology, MIMER Medical College, Talegaon Dabhade, Pune, Maharashtra, India

Objectives: To study the prevalence of potential drug-drug interactions (DDI), their severity, clinical significance, and their association with patient characteristics in Intensive Care Unit (ICU) at a tertiary care hospital. Materials and Methods: A prospective, observational study was conducted for a period of 3 months (July-September 2014) to assess the potential DDI using Medscape Drug Checker Software and Lexi-Comp, Inc. Version: 2.7.5. Drug interact android mobile application. Results: A total of 180 patients were included in the study with a prevalence of 77.78% potential DDI, majority of which were suffering from cardiovascular conditions (30%). In those with hospital stay more than five days, 65.73% had potential DDI. There were 229 potentially interacting drug pairs with corticosteroids, aspirin, beta blockers, and diuretics being commonly involved in potential drug interactions. A total of 2336 interactions were observed with an occurrence rate of 3.08 DDI per patient. Severity was moderate in 64.63%, pharmacodynamic mechanism in 72.49%, and 60.26% had risk rating category C. Conclusion: The present study showed high concomitant administration of potentially interacting drugs. The prevalence confirmed the association of duration of hospital stay and polypharmacy. Vigilant prescribing approach is needed to prevent hazardous outcomes of potential DDI.

CLP-6

Cost Evaluation of Pharmacotherapy in Patients with Diabetic Nephropathy Attending Nephrology Department in a Tertiary Care Hospital


Josephine Valsa Jose 1 , Padmini Devi 1 , Renuka Satish 2

1 Department of Pharmacology, St. John's Medical College, Bengaluru, Karnataka, India, 2 Department of Nephrology, St. John's Medical College Hospital, Bengaluru, Karnataka, India

Objectives: To evaluate the cost of pharmacotherapy and its determinants in diabetic nephropathy (DN) in Nephrology department of a tertiary care hospital. Material and Methods: Prospective observational study was conducted among adult patients visiting Nephrology OPD (March-July 2015). Data on demography, investigations, medications, direct cost (dialysis, investigations, medical consultation charges, drugs, AV fistula charges, and cost of travel) and indirect costs (transportation, lost wages) were analyzed. We used Chi-squared test for categorical variables and multivariate linear regression analysis to identify determinants of cost of pharmacotherapy and total cost. Results: Out of 100 patients, 50% of the patients were >60 years; 75% were male. Hypertension (97%) was the commonest comorbidity. 60% belonged to stage 5 DN. 59% were on dialysis. Mean no. of drugs per patient is 7.60 ± 2.44. The total monthly cost per patient amounted to INR 24,203.27 with total direct cost of INR 21,013.90 (87%) and indirect cost of INR 3189.30 (13%). The monthly cost of dialysis and pharmacotherapy per patient were INR 9060.00 (37%) and INR 2535.98 (11%) respectively. Monthly cost of dialysis (Std β coeff 0.655, p = 0.000), pharmacotherapy (βcoeff 0.350 p = 0.000), no. of comorbidities (β coeff 0.021, p = 0.020), were predictors of total cost. Total no of drugs (β coeff 0.346, p = 0.000) and stage of DN (β coeff 0.259, p = 0.003) were determinants of cost of pharmacotherapy. Conclusion: The cost of treatment of DN was substantial. Cost of pharmacotherapy was an important predictor of total cost. Stage of DN and total no of drugs prescribed were determinants of cost of pharmacotherapy.

CLP-7

An Evaluation of Drug Promotional Literatures Published in Scientific Medical Journals


Vachhani PM, Solanki MN, Desai MK

Department of Pharmacology, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India

Objectives: Evaluation of ethical standards of published drug promotional literatures (DPLs) in different Indian and non-Indian scientific medical Journals and its comparison regarding compliance to World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) guidelines. Materials and Methods : A cross-sectional, observational study was carried out at B.J. Medical College, Ahmedabad. DPLs published in Indian and non-Indian scientific medical journals available at central library of B.J. Medical College during the period of 6 months were collected according to selection criteria. DPLs were evaluated and compared for compliance to ethical standards for drug promotion laid by WHO and IFPMA. Data were analyzed using fisher's exact test. Results: Out of total 178 DPLs, 103 were from Indian journals and 75 were from non-Indian journals. When compared regarding compliance to all the eleven ethical criteria of WHO, no significant difference was found between DPLs published in Indian and non-Indian journals. However, information regarding dosage regimen (P: 0.0096), ADRs (P: 0.0028), warnings (P: 0.0104) and major drug interactions (P: <0.0001) was significantly less in DPLs of Indian journals as compared to non-Indian journals. DPLs fulfilling all the five IFPMA criteria were significantly more in non-Indian journals (88%) as compared to Indian journals (39%) (P < 0.0001). Conclusion: Noncompliance to ethical standards was found more common in DPLs of Indian journals as compared with non-Indian journals. Thus strict implementation of regulatory measures regarding DPLs published in Indian medical journals is recommended.

CLP-8

Profile of Metabolic Disorder, Administered Corrective Therapy and Their Relation to Disease Profile in Benign Prostatic Hyperplasia


Vikrant Panwar, Alok Singh, Dwivedi US, Pandey DL

Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India

Objectives: Benign prostatic hyperplasia (BPH) is highly prevalent in older men. Despite the high prevalence, its pathogenesis is not well understood. An increasing number of reports have suggested a possible relationship between BPH and several metabolic disturbances, known commonly as Metabolic Syndrome (MetS). In this study we tried to find out the relation between metabolic syndrome and benign prostatic hyperplasia and the effect of therapies of metabolic syndrome on prostatic profile. Materials and Methods : 93 patients of BPH were enrolled in the study & divided in three groups on the basis of metabolic syndrome and its therapies. All the patients were given alpha blocker treatment. Data of metabolic parameters (FBS, Lipid Profile, waist circumference) and prostatic parameters (prostate volume, PSA, IPSS, Uroflowmetry) were collected in all three groups at baseline, 3 months and 6 months follow up thereafter to compare the profiles with appropriate statistical analysis. Results: At the outset patients with untreated metabolic syndrome had worst prostate profile as compared to without MetS or MetS with treatment. In the follow up, metabolic therapies along with alpha blocker proved superior to alpha blocker alone in metabolic syndrome patients. Conclusion: These findings indicate positive co-relation between MetS and worsening of BPH pathology. Metabolic Syndrome must be diagnosed and treated in patients of BPH. It may be even worthwhile to address metabolic disturbances that fall short of metabolic syndrome definition.

CLP-9

Comparative Study of Vecuronium Bromide With Rocuronium for Evaluating the Changes in Mean Arterial Blood Pressure and Heart Rate in Patients Undergoing Surgeries


Goggy Pappy George, Alen Mathew

Department of Pharmacology, KVG Medical College and Hospital, Sullia, Dakshina Kannada, Karnataka, India

Objectives: The aim of this study was to compare the change in blood pressure and heart rate using vecuronium versus rocuronium for maintenance in patients undergoing surgical procedures. Materials and Methods: 100 patients were randomly divided into 2 groups. All patients were induced with 5 mg.kg -1 of thiopentone sodium and intubation conditions were achieved with 1.5 mg.kg -1 of suxamethonium, using a well lubricated cuffed endotracheal tube of appropriate size. When the patient started to breathe spontaneously, they were administered either 0.6 mg.kg -1 of rocuronium (Group A) or 0.1 mg.kg -1 of vecuronium (Group B). Hemodynamic parameters (heart rate and mean arterial pressure) were monitored before administering the drug; at 1, 5, 10, 15 and 20 minutes after the drug and at the end of the surgery. Results: The heart rate increased significantly at one minute and five minutes after administration of rocuronium (83.76 ± 10.37 and 86.8 ± 9.98) unlike vecuronium. But it gradually declined towards normal and change in heart rate with either drug was not significant beyond 10 minutes. The mean arterial pressure decreased significantly at one minute after administration of rocuronium (96.68 ± 7.57) which later showed a gradual increasing trend when compared to vecuronium which had no statistically significant change at any time. Conclusion: For short surgical procedures rocuronium is a good alternative to vecuronium, as the drug is reasonably cardio stable, produces excellent intubation conditions, has shorter duration of action and shows minimal cumulative effect.

CLP-10

To Study the Pattern of Suspected Adverse Drug Reactions in Patients Coming to the Department of Dermatology in Gauhati Medical College and Hospital, Guwahati, Assam


Binita Singha 1 , Ajoy Borah 1 , Mangala Lahkar 1 , Ratan Lihite 2

1 Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India, 2 ADR Monitoring Centre, Gauhati Medical College, Guwahati, Assam, India

Objectives: To study the pattern of suspected adverse drug reactions in patients coming to the department of dermatology in Gauhati medical college and hospital, Guwahati, Assam. Materials and Methods: Cross-sectional study. The Suspected adverse drug reactions reported from the department of Dermatology in the spontaneous ADR reporting form were analysed in this study over a period of one year. Results: A total of 513 cases of reported ADRs were analyzed. The highest number of ADRs were reported in the Age group 21-40 years with female preponderance. Erythematous maculopapular lesions were the most common ADR and maximum cases of ADRs were observed with steroids. Most cases were found to be probable (Causality assessment), of mild severity and were probably preventable. Conclusion: The study showed that a number of drugs cause dermatological ADRs. These ADRs vary in their appearance, duration, causality, severity, and preventability.

CLP-11

Comparison of the Efficacy of Diazepam and Gabapentin Premedication on Preoperative Anxiety in Cataract Surgery Patients


Derly John, Gagandeep Kwatra, Dinesh Badyal K, Nitin Batra

Department of Pharmacology, Christian Medical College and Hospital, Ludhiana, Punjab, India

Objectives: To compare the efficacy of diazepam and gabapentin premedication on preoperative anxiety in patients undergoing cataract surgery. Materials and Methods: 120 patients undergoing cataract surgery under peribulbar block were enrolled and randomly divided into two groups of 60 patients each. Group A received diazepam 10 mg orally and group B received gabapentin 600 mg orally, 2 hours prior to the surgery. Preoperative anxiety was assessed at baseline and 2 hours after administration of the drug using 'The Amsterdam Preoperative Anxiety and Information Scale' (APAIS). Mean values were compared and p < 0.05 was considered statistically significant. Results: The mean baseline preoperative anxiety was 17.50 + 1.79 and 17.83 + 1.70 in group A and B respectively and was comparable (p = 0.239). In group A, the mean preoperative anxiety score decreased to 14.60 + 1.96 from the baseline score (p < 0.001) whereas in group B, the mean preoperative anxiety score decreased to 10.57 + 2.05 from an initial score of 17.83 + 1.70 (p < 0.001). On comparing the two groups, group B showed a greater reduction in preoperative anxiety scores than group A, 2 hours after the drug administration. This difference was statistically significant (p < 0.001). Conclusion: Both oral diazepam and gabapentin as a premedication before cataract surgery reduce preoperative anxiety significantly. However, the reduction in preoperative anxiety is significantly more with oral gabapentin than diazepam.

CLP-12

Drug Utilization Pattern in the Female Reproductive Tract Infections in a Tertiary Care Hospital


Ameena Khatoon Koralli, Kokila BN, Vijayaraghavan S

Department of Pharmacology, KVG Medical College, Sullia, Dakshina Kannada, Karnataka, India

Objectives: To analyze the trend and pattern of drug prescriptions for Female Reproductive Tract Infections (FRTIs) in a tertiary care teaching hospital. Materials and Methods: A prospective observational study was carried out for a period of 18 months. 397 prescriptions were collected from Gynaecology department in K.V.G Medical College Hospital, Sullia. Data pertaining to the types of FRTIs, investigations, antimicrobials and adjunctive medications prescribed were recorded in a specially designed proforma. Results: The mean (±SD) age of patients was 35.33 ± 8.6 years. The average number of Antimicrobials per prescription was 3.1 ± 1.25. Polytherapy was observed in 92.7% of the prescriptions. Among the infections reported the most common was Pelvic Inflammatory Disease (PID) (52.9%) followed by cervicitis (13.1%), vaginitis (13.1%), vulvitis (10.6%) and endometritis (6.3%). In a total of 397 patients, culture and sensitivity tests were performed in 148 patients and micro-organism isolates were seen in 129 cases. The notable microbes isolated were Coagulase Negative Staphylococcus aureus (23.6%), candida (18.3%), bacterial vaginosis (16.3%) and E. coli (11.5%). Among antimicobials, anti-parasitic agents (34.3%) were most commonly prescribed, followed by cephalosporins (29.5%), anti-fungals (11.7%), tetracyclines (11.5%), aminoglycosides (7.4%), fluoroquinolones (4%) and others (1.6%). The first 5 AMAs forms DU90% segment. In the adjunctive therapy, analgesics (23.2%), Gastoprotective agents (22.7%), nutrients (19.2%), anti-emetics (14.3%), and anti-histamines (8.8%) were prescribed. There was significant association observed between the nature of disease and type of treatment. Conclusion: This study shows that the particular FRTIs referred herein, at this hospital, were treated in accordance with standard practice guidelines.

CLP-13

To Study the Relationship Between Blood Glucose and Serum Lipids in Patients with Dyslipidemia Receiving Atorvastatin


Gauri Hari Kasabe, Smita Anand Tiwari, Balasaheb Baburao Ghongane

Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India

Objectives: This study was done to assess effect of Atorvastatin 10 mg on blood glucose level, serum lipid levels and interrelationship amongst these parameters. Materials and Methods: This prospective study was conducted in a tertiary care hospital. Diabetic group (n = 30) and non-diabetic group (n = 30) receiving Atorvastatin were studied for their blood glucose (fasting and post-prandial) and serum lipids (LDL, HDL, TG, TC, LDL/HDL, VLDL). Blood tests were done at baseline and were repeated at 3 and 6 months. Data was analyzed using graph pad prism 6 software. Results: The diabetic group showed significant increase at 6 months in blood glucose level (fasting and post-prandial) from baseline (p < 0.0021 and 0.0054). Whereas non-diabetic did not show such changes (p = 0.5158). Serum lipids (LDL, TG, TC, VLDL) significantly decreased (p < 0.0001) while HDL levels increased (p = 0.0391 and 0.0007) in both the groups at 6 months. Also LDL/HDL levels decreased significantly (p = 0.0380 and < 0.0001). The diabetic group showed negative insignificant correlation (r = -0.203, p = 0.282) whereas non-diabetic group show positive insignificant Correlation (r = 0.042, p = 0.827) between blood glucose and total cholesterol levels. Conclusion: Atorvastatin causes significant rise in blood glucose (fasting and post-prandial) only in diabetic patients. However, significant improvement in lipid profile was noted in both groups. In diabetic group fall in total cholesterol level is correlated with rise in blood sugar but in non-diabetic group rise in total cholesterol level is correlated with rise in blood sugar, even though not statistically significant in both groups. This needs to be further explored with larger sample size.

CLP-14

A Prospective Noninterventional Study to Compare Safety and Efficacy of Brimolol (Timolol + Brimonidine) and Timolol on Intra-ocular Pressure in Newly Diagnosed Primary Open Angle Glaucoma (poag) Patients in a Tertiary Care Hospital


Akhil agrawal

Objectives: To evaluate efficacy of Timolol and Brimolol by evaluating intra ocular pressure and also study their effect on cornea, conjunctiva and tear glands. Materials and Methods: This is a prospective study which includes 60 cases of newly diagnosed POAG from ophthalmology inpatients divided into 2 groups: 1-Timolol and 2-Brimolol (Brimonidine + Timolol). A baseline clinical examination of the patient will be done at enrolment with each group of patient administered with the topical anti-glaucoma drugs followed up once in 15 days. The allocation of the patients in group 1 will be as per the clinician while in group 2; it will be according to simple randomization. The efficacy of the drug will be tested based on IOT measurement by Non-contact tonometer, slit lamp examination and fundoscopy at interval of 15 days. The safety of anti-glaucoma drug will be tested on the basis of ADR check list; fundoscopy and slit lamp examination with emphasis on central corneal thickness and tear film break up time. Results: The mean reduction in IOP in group 1 and 2 are 2.7 and 7.9 mmHg at 15 days and 6 & 11 mmHg at 30 days respectively. The frequency of ADR in group 1 are 36% & 40% respectively with the most frequent ADR in group 1 as burning of eyes (50%) & in group 2 as dryness (22%). The effect of brimolol on schirmer test II was clinically significant with a mean difference e of 4.33 mmHg. The frequency of patients missing ophthalmic doses were 60% &48% and the frequency of patients quitting treatment was 9% & 14% in group 1& 2 respectively with monetary reason as the most common cause. The most frequent cause of missing ophthalmic doses was ADR (30%) in group 1 while in group 2; it was monetary reason (43%) predominantly in lower class. The GQR-15 score was 35 & 30.5 in group 1 & 2 respectively. Conclusion: Twice daily fixed brimolol provides superior IOP lowering to timolol monotherapy but it is less well tolerated and quite costly for the patients. Brimolol substantially reduces tear gland secretion while timolol shows no such effect.

CLP-15

Drug Utilization Pattern in Respiratory Tract Infections in a Tertiary Care Hospital in Karnataka


Pal Paramita 1 , Bhattacharyya D 1 , Herle M 2 , Vijayaraghavan S 2 , Kokila BN 2 , Sen S 1

1 Department of Pharmacology, IIMSAR Medical College and Hospital, Haldia, West Bengal, India, 2 Department of Pharmacology, KVG Medical College and Hospital, Sullia, Dakshina Kannada, Karnataka, India

Objectives: Respiratory tract infections are common clinical problems in the general population. Antimicrobials are the mainstay in the management and irrational use of them may increase resistance to bacteria and the total cost of treatment. To evaluate the pattern of drug prescriptions for respiratory tract infections in Medicine and Pediatric departments of a rural teaching hospital. Materials and Methods: Over a period of 18 months, 603 medical case records of respiratory tract infections were collected. The drugs prescribed, their dose and duration of treatment were recorded. DU 90% was calculated. Results: The mean (±SEM) age of the patients was 38.55 ± 0.9 years and there were 349 (57.87%) men and 254 (42.12%) women. The most commonly occurring respiratory disease was acute rhinitis (42.78%), while the least common was atypical pneumonia (0.49%). Microbial culture and sensitivity was done in 195 patients and Klebsiella pneumonia (9.74%) was the most common and Enterococcus (1.02%), Streptococcus pneumonia (1.02%) were the least common organisms. Penicillins (35.77%), cephalosporins (28.31%), antitubercular drugs (12.46%), macrolides (8.53%), aminoglycosides (4.20%) and fluoroquinolones (4.06%) constituted DU 90%. Monotherapy was advocated in 41.95% and polytherapy in 27.36% of patients. The average number of antimicrobials prescribed per prescription was 1.22 ± 0.05. Two thirds (67.56%) of the prescribed drugs were from the national list of essential medicines 2011 (NLEM). Conclusion: Penicillins and cephalosporins were the commonly used antibiotics for respiratory tract infections among patients in the hospital. Two thirds of the prescribed drugs were essential medicines. Prescription of antimicrobials was rational and in consensus with standard guidelines.

CLP-16

A Prospective Study of the Pattern of Drugs Used in Primary Dysmenorrhoea in King George Hospital, Visakhapatnam


Rachana M, Sudha J, Ratna Kumari B, Sheena M, Madan Kumar A, Sirisha

Department of Pharmacology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India

Objectives: To study the pattern of drug use in primary dysmennorhoea in King George Hospital, Visakhapatnam. Materials and Methods: After taking permission from the institutional ethics committee, this study was carried out in Obstetrics and Gynecology OPD in KGH Visakhapatnam, for 4 months among 100 patients with primary dysmenorrhoea. The analysis was done for the pattern of drug use, prescribing frequency of individual drug, to evaluate association between severity of dysmenorrhoea and prescription pattern and adequacy of prescription details. Results: Mefenamic acid and dicyclomine combination was frequently (75%) prescribed, followed by mefenamic acid alone (18%), and Diclofenac (7%). Although majorities (43%) of the patients with severe dysmenorrhoea were prescribed mefenamic acid with dicyclomine combination, the severity of dysmenorrhoea did not influence the prescription pattern and choice of drug (p > 0.05). Conclusion: In our present study, NSAIDS and their combination with antispasmodics were prescribed more frequently irrespective of severity of pain.

CLP-17

A Comparative Study of Ondansetron and Metoclopromide for Prevention of Nausea and Vomiting Following Elective lscs Under Spinal Anesthesia


Tamboli Tushar, Pundarikaksha HP, Narendra Babu MC

Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India

Objectives: To study the comparative efficacy of Ondansetron and Metoclopromide in prevention of PONV in patients undergoing elective LSCS under spinal anesthesia . Materials and Methods: 100 subjects with ASA I & II undergoing elective LSCS under spinal anesthesia with 0.5% hyperbaric bupivacaine were allocated into two groups of 50 each. Group A received Ondansetron 4 mg IV and Group B Metoclopromide 10 mg IV, just before induction of anesthesia. The postoperative nausea was assessed by VAS (0-10) and vomiting by number of episodes, recorded at 2 hr, 6 hr and 24 hr following surgery. Data was analyzed using Mann Whitney U test and Chi Square test, and descriptive statistics was used wherever necessary. Results: Higher incidence of postoperative nausea was observed with metoclopromide group than ondansetron at 2 hr (p = 0.02) and 6 hr (p = 0.014) which was statistically significant, but the scores at 24 hr were similar. However, there was no statistically significant difference in episodes of vomiting in between the groups at 2 hr, 6 hr and 24 hr. Need for a rescue antiemetic was lesser in ondansetron group (p = 0.026) as compared to metoclopromide group. Conclusion: Prophylactic use of ondansetron is more effective than metoclopromide in prevention of PONV following elective LSCS under spinal anesthesia.

CLP-18

A Pilot Study on Identification of Biomarkers for Early Detection, Prevention and Treatment of Pregnancy Induced Hypertension


Heta Vyas 1 , Ramesh Goyal 2 , Gautam Vyas 3

1 Maliba Pharmacy College, Uka Tarsadia University, Surat, Gujarat, India, 2 VClinBio Labs, Central Research Facility, Sri Ramchandra Medical Centre, Chennai, Tamil Nadu, India, 3 Mamta Hospital and Maternity Home, Surat, Gujarat, India

Objectives: Pregnancy-induced hypertension (PIH) which includes gestational hypertension and pre-eclampsia complicates 5-10% of all pregnancies. Its identification and management play a significant role in outcome of pregnancy but the mechanisms responsible for the pathogenesis of preeclampsia are unclear and limit effective intervention. The aim of study was to identify risk factors and recognize specific biomarkers for early detection, prevention and treatment of PIH. Materials and Methods: A case-control study was conducted on 121 hypertensive and 1415 normotensive pregnant women at Mamta hospital and maternity home, Bardoli, and risk factors were identified. A cross-sectional study involved measurement of various pro-inflammatory cytokines using ELISA. Results: From case-control study it was observed that the following factors, with statistical significance (p < 0.05), are associated with increased odds of PIH: primi gravida (OR = 1.8), twin gestation (OR = 12.5), history of missed abortion (OR = 5.5) and history of treatment for infertility including IVF (OR = 2.1). Mean values of VEGF, IL-1, IL-4, IL-5, IL-12, IL-13 and TNF-α levels for normotensive women were 12.0, 3.0, 4.8, 3.1, 60.0, 45.6 and 14.2 pg/ml and for women with PIH were 21.8, 7.6, 17.9, 2.4, 866.0, 4862.4 and 3.2 pg/ml respectively. However, these values were not statistically different in the two groups. Conclusion: The placenta can be a culprit for causing PIH as history of missed abortion, infertility treatment, multiple-gestation are related to placenta. That might be the reason for elevation of pro-inflammatory biomarkers in women with PIH as compared to normotensive pregnant women though not statistically. The role of these cytokines as causative and as targets for drugs needs further research.

CLP-19

A Randomized, Prospective Study Comparing Single Dose Epidural 0.2% Levobupivacaine with 25 μg Fentanyl and Single Dose Epidural 0.2% Ropivacaine with 25 μg Fentanyl for Post-operative Analgesia following Elective Lower Limb Surgeries


Santhosh Kumar R 1 , Basavanna PL 1 , Sudarshan MB 2

1 Department of Pharmacology, Mysore Medical College, Mysore, Karnataka, India, 2 Department of Anaesthesia, Mysore Medical College, Mysore, Karnataka, India

Objectives: Levobupivacaine & Ropivacaine were developed mainly to overcome the fatal cardiotoxicity that can occur with bupivacaine. This study is aimed to compare the efficacy & safety of 0.2% levobupivacaine with 25 μg Fentanyl & 0.2% ropivacaine with 25 μg Fentanyl in patients undergoing lower limb orthopaedic surgeries. The objectives were to record and compare the onset, peak and duration of postoperative analgesia using visual analogue scale (VAS). Materials and Methods: After obtaining the institutional ethical committee approval, 60 patients (calculated using prevalence 0.04) belonging to American society of anaesthesiologists (ASA) grade I & II of both sexes, of age within 20-60 years were included. Study was conducted for a period of one year at K.R. Hospital, Mysore medical college. For each patient written informed consent was obtained. Patients were randomly divided into 2 groups (using computer generated numbers) group-A which received 8 ml of 0.2% levobupivacaine with 25 μg fentanyl & group-B which received 8 ml of 0.2% ropivacaine with 25 μg fentanyl. Post operatively when patient complained of pain (VAS score >4), 8 ml of test drug combination was given epidurally & the parameters were recorded periodically until the pain reappeared (VAS score >4). Statistical tests used were t-test (paired & unpaired), repeated measures ANOVA using SPSS version 20.0. Results: Demographic profile, mean duration of surgery, hemodynamic parameters were comparable in both groups. The onset, peak, duration of analgesia in levobupivacaine group is 4.20 +/- 1.375 mins, 29.70 +/- 4.78 mins, 325 +/- 16 mins and in ropivacaine group is 3.13 +/- 0.973 mins, 21.80 +/- 2.722 mins, 210 +/- 24.914 respectively and is statistically significant. Conclusion: 0.2% Levobupivacaine with 25 μg Fentanyl provides better post operative analgesia with similar haemodynamic stability compared to 0.2% Ropivacine with 25 μg Fentanyl.

CLP-20

Antimicrobial Resistance Pattern in King George Hospital Visakhapatnam


Ratna Kumari, Sudha J, Madan Kumar, Rachana M, Sheena M, Mitisha

Department of Pharmacology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India

Objectives: The objective of this study is to identify the group of organisms developing resistance, to know the class of drugs against which resistance has emerged and to assess the possible factors that can favor the development of resistance. So that antibiotics can be formulated for the proper and effective use of antibiotics. Materials and Methods: After taking permission from the institutional ethics committee the data regarding culture and sensitivity of organism isolated from different sources such as urine, blood, wound swab, stools, sputum and tracheal aspirations were collected. Identification of organisms to the genus and/or species level and antimicrobial sensitivity was carried out as per the clinical and laboratory standards and institute guidelines on the 480 samples received from June 10 2015 to September 20 2015 in Microbiology Department in King George Hospital, Visakhapatnam. Results: Out of 480 samples, 60 (12.5%) showed significant growth of organisms exhibiting resistance to either single or multiple drugs.  Escherichia More Details was the most common organism isolated with a total of 19 (31.6%), followed by Methicillin sensitive Staphylococcus aureus 13 (21.6%), Klebsiella 12 (20%), Methicillin resistant Staphylococcus aureus 8 (13.3%). Maximum resistance was observed with commonly used first line antimicrobials such as co-trimoxazole, Ampicillin, amoxicillin, fluoroquinolones, third generation cephalosporins. Least resistant or highly sensitive were amikacin, nitrofurantoin, gentamycin, and doxycycline among gram negative bacteria. Conclusion: Antimicrobial resistance was more with hospital acquired organisms and commonly used antibiotics. Periodic antimicrobial resistance monitoring is suggested to restrict further emergence of resistance.

CLP-21

Evaluation of Prescription Pattern in Hypertensive Pregnant Women Treated with Antihypertensives Attending the Department of Obstetrics and Gynaecology of Gauhati Medical College Hospital


Chimi Handique, Arijit Dutta, Mangala Lahkar

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objectives: The objective of the study was to evaluate the prescription pattern in hypertensive pregnant women treated with Antihypertensives attending the Department of Obstetrics and Gynaecology of Gauhati Medical College Hospital. Materials and Methods: An observational prospective study was conducted from April 2014 to Sept 2014 including both outpatient and inpatient cases of hypertension in pregnancy after due approval from Institutional Ethics Committee. Results: A total of 100 prescriptions were evaluated. The most commonly prescribed antihypertensive was Methyldopa, followed by labetalol. The other drugs prescribed were Nifedipine, Frusemide, Amlodipine and Atenolol. Single drug therapy was prescribed in 58% patients. The use of fixed dose combinations was low. Most patients were in the age group of 18-22 years and gestational age group of 25-30 weeks. 56% of patients were multigravida. The number of patients suffering from Preeclampsia, Gestational hypertension, Eclampsia and Chronic hypertension were 65, 20, 9 and 5 respectively. Most of the antihypertensive drugs prescribed were from FDA category B and C. WHO core indicators and facility indicators were also analyzed. Conclusion: The incidence of single drug therapy was high. Methyldopa was the highest prescribed drug. There is scope for carrying out such studies in other parts of this region so that therapeutic guidelines could be revised accordingly to give the best care to the community.

CLP-22

Study on Bacteriological Profile and Antibiotic Susceptibility Pattern in View of Emerging Resistance in Neonatal Septicemia Cases Admitted in NICU of Andhra Medical College, Visakhapatnam


Meher Sheena, Mitisha, Madan Kumar, Rachana M, Ratna Kumari, Susmitha Y

Department of Pharmacology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India

Objectives: This study was done to determine the bacteriological profile and antibiotic susceptibility pattern in neonatal septicemia cases which were admitted in NICU of Andhra medical college in view of emerging drug resistance. Materials and Methods: This study was conducted prospectively on 140 suspected neonatal septicemia cases from 1-3-2015 to 1-7-2015 in the NICU of Andhra medical college at Visakhapatnam after taking permission from the Institutional Ethics Committee. Data regarding bacteriological profile and the antibiotic susceptibility pattern were analyzed from the blood sample reports which were sent to the microbiology lab for analysis. The cases were categorized depending upon the time of presentation as early onset septicemia (<72 hrs of life) and late onset septicemia (>72 hrs of life). Results: A total of 140 cases were studied and results were analyzed using 2007 Microsoft Excel. The most common pathogens isolated were, Klebsiella Pneumoniae (35%), E. coli (24%). Gram negative organisms were moderately susceptible to Amikacin and Ciprofloxacin and were highly susceptible to Meropenem. Gram positive organisms were moderately susceptible to Amikacin, 3 rd generation cephalosporin and Ciprofloxacin and were highly susceptible to linezolid and Vancomycin. Conclusion: Gram negative bacteria were more commonly the cause of sepsis and Klebsiella was the predominant pathogen. Gram negative bacteria were resistant to routinely used antibiotics. Their resistant pattern should considered essential before starting the empirical treatment. Positive blood culture with antibiotic sensitivity is the best guide to antimicrobial therapy. Injudicious usage of antibiotics should be avoided to prevent the development of resistant forms.

CLP-23

Evaluation of Evidence Based Adverse Drug Reaction Monitoring and Clinical Pharmacist Role in a Tertiary Care Hospital


Gayathri Rajan, Venkateswarlu V, Narendra Babu A, Sathish Kumar M, Rama Rao N

Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Objectives: A prospective observational study was conducted for a period of eight months in a tertiary hospital. The main aim of the study was to evaluate the evidence based adverse drug reaction monitoring and to know the clinical pharmacist role in tertiary care hospital. Materials and Methods: All patients of either sex visited different departments in a tertiary care hospital during the study period were evaluated for drug induced reactions, patients developed with adverse drug reaction during the hospital stay, hospitalized due to adverse drug reaction are monitored by interviews the patients consulting with physician and reviewing the patients chart. Patients demographic data were recorded the onset of reaction and duration of reaction suspected drug out come and action taken by managing the adverse drug reaction is recorded. Causality and severity assessment were performed by using Naranjios adverse drug reaction probability scale and modified hart wig scale. Results and Conclusion: In this study the total number of adverse drug reaction was 77. We observed females predominance over males. The majority of adverse drug reactions were reported from Department of General Medicine followed by Oncology and the most affected organ system is whole body followed by skin. The drugs which mostly implicated the adverse drug reactions were antibiotics followed by NSAIDs.

CLP-24

Prospective Study on Pharmacological Management of Ischemic Stroke and Treatment Cost Analysis in a Tertiary Care Hospital


Narendra Babu A, Nagalakshmi J, Sathish Kumar M, Eswar Tony D

Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Objectives: The study was carried out to evaluate the pharmacological management of ischemic stroke and treatment cost analysis in a tertiary care hospital, to evaluate the clinical features of a consecutive series of patients with ischemic stroke and to assess the changes in the clinical management of the patients over the study period. Materials and Methods: The study was a hospital based prospective study and has been carried out for a period of 9 months. Data was collected from case sheets of patients who are admitted in a stroke unit in tertiary care hospital. The following data were observed: demographic characteristics, family history, risk factors, neurological examination findings, diagnostic data and the type of treatment including its cost. Results: According to types of stroke out of 200 selected patients, 75 patients (57.5%) affected with recurrent cardiovascular accidents, 40 patients (20%) affected with recurrent trans ischemic attack, 55 patients (17.5%) affected with Posterior Circulation Stroke and 40 patients (20%) effected with Cardio embolic stroke. Social habits peoples are 75 patients (57.5%) with smoking, 80 patients (58%) with alcoholic and 57 patients (25%) both smoking & alcoholic. Disability after stroke is among 200 patients, 120 patients (60%) were Hemiplegic, 55 patients (26%) were Hemi paresis, 15 patients (7.5%) were Paraplegia, and 15 patients (7.5%) were quadriplegia. Conclusion: Mainly thrombolytic and anti platelet drugs were founded to be effective in the management of stroke. The average cost for the emergency treatment of an acute stroke patient is almost about 2000-10,000 for medical treatment and 3200 per day for nonmedical treatment. Immediate identification of stroke with in 3 hrs was found to be very important in the management of stroke.

CLP-25

Survey on Knowledge-Attitude-Practice Concerning Insulin Use in Adult Diabetic Patients in Visakhapatnam


Madan Kumar A, Sudha J, Meher Sheena D, Rachana M, Ratna Kumari D, Mitisha

Department of Pharmacology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India

Objectives: The present study was conducted to assess knowledge, attitude and practice regarding insulin use among type 1 and type 2 diabetic patients. Materials and Methods: Approval from the Institutional Ethics Committee was taken before starting the study. Type 1 and Type 2 diabetic patients, aged 18 years and above, attending the Medicine/Endocrinology out-patient department or admitted as in-patients in King George Hospital, Visakhapatnam were enrolled in the study. Data from 296 patients was collected using a pre-tested structured questionnaire comprising of 51 questions and the responses were analyzed. Results: Literate patients and patients who had been on treatment for a longer duration had shown a better understanding of insulin use. Female subjects were seen to be less aware of HbA1c as a blood sugar monitoring tool. Among the patients included in the study, 70% had never used a glucometer; only 27.33% carried simple carbohydrates for use in hypoglycemic attacks and 32% failed to rotate sites for insulin injection. Conclusion: The present study has brought to light that there are a few deficiencies in the knowledge, attitude and practices regarding the use of insulin in the patients with type 1 and type2 diabetes. This can definitely be improved through proper guidance and counseling.

RDU

RDU-1

Survey of Use of Over the Counter and Other than over the Counter Drugs Among Medical Students, Nursing and Technician Staff of a Tertiary Care Teaching Hospital


Priyanka Patel, Kamlesh Patel, Devang Rana, Harsh Joshi, Supriya Malhotra

Department of Pharmacology, Smt. NHL Municipal Medical College, Ahmedabad, Gujarat, India

Objectives: To find out pattern and extent of use of OTC and other than OTC drugs among medical students, nursing and technician staff of a tertiary care teaching hospital. Materials and Methods : Study began after taking permission and approval from Institutional Review Board (IRB). Medical student, nursing and technician staff of tertiary care teaching hospital was enrolled after written informed consent. Prevalidated questionnaire regarding use of such use was administered to each participant. Results : A total of 200 participants responded to questionnaire, M:F ratio was 1:1.7. Majority of the participants had taken OTC drugs for cough/cold (72.6%) followed by headache/bodyache (71.1%). Paracetamol (47.3%) followed by ibuprofen (37.8%) were the most common drugs taken. About 85% participants had taken antimicrobial considering it as an OTC product. Most commonly used antimicrobials were metronidazole (19.4%) followed by levofloxacin (17.9%). Most common reason for self medication was the perception that the disease wasn't serious (44.8%), favourable prior experience (42.8%), good opinion from family members (42.8%) and influenced by advertisement (34.3%). About 52% requested for drug by mentioning name of drug. Most (50.7%) felt that OTC drug improved their illness. 45.9% stopped when symptoms disappeared. Majority of the participants (57.2%) believed use of OTC drug is a good practice. Most of the participants (56.7%) believed they can treat symptoms with OTC drugs. 64.7% participants believed use of OTC drug is beneficial for them. Most of the participants lack the knowledge for dose (73.6%) and frequency (68.2%) of drug. A substantial number of participants (58.61%) were taking drugs outside OTC list. Conclusion : Awareness and dangers of misuse of OTC medications among all the participants was little. Therefore it is suggested that proper education should be imparted regarding illness where self-administration of OTC drugs to be employed.

RDU-2

Potential Drug-Drug Interactions Among Hospitalized Cardiac Patients


Ajay Shanbhag, Hema G

Department of Pharmacology, Mysore Medical College and Research Institute, Mysore, Karnataka, India

Objectives: DrugDrug Interaction (DDI) is of major concern in patients with complex therapeutic regimens. Patients with cardiovascular disorders, in particular, are at higher risk of DDI due to the increased number and multiple classes of drugs they receive. To identify potential drug-drug interactions among hospitalized cardiac patients and to identify the risk factors associated with these interactions. Materials and Methods: After obtaining approval from Institutional Ethical Committee, a prospective observational study was carried out among 367 hospitalized cardiac patients in a tertiary care hospital, Mysore. Cardiac patients prescribed at least 2 drugs and having hospital stay of more than 24 hour duration were enrolled into the study. The prescriptions were analysed for potential DDI using computerized DDI database system (MEDSCAPE). Descriptive statistics, Chi-Square test and Cramer's V test were used to analyse the results. Results: The incidence of potential DDI was 98% with 360 patients having at least one interacting drug combination. A total of 67 serious (18.2%), 346 significant (94.3%) and 141 minor (38.4%) interactions were identified. Aspirin/clopidogrel (71.1%) and pantoprazole/clopidogrel (69.8%) were the most common interacting pairs. Drugs most commonly involved were aspirin, clopidogrel, heparin, pantoprazole and ramipril. Majority of interactions were pharmacodynamic (78.6%) in nature. Increased number of medicines, prolonged hospital stays and comorbid conditions were the risk factors found associated with the potential DDI. Conclusion: This study emphasizes the need to exercise caution during therapeutic planning and to intensely monitor the cardiac in-patients to avoid dangerous consequences as a result of DDIs.

RDU-3

Analysis of Drug Prescribing Trends in Treatment of Rheumatoid Arthritis at a Tertiary Care Hospital, Karnataka


Dharani Devangi, Vijayaraghavan, Rajasekhar CH, Kokila BN

Department of Pharmacology, KVG Medical College and Hospital, Sullia, Dakshina Kannada, Karnataka, India

Objectives: This study proposes compilation, analysis of pattern, trend, rationality and frequency of use of drugs in the treatment of rheumatoid arthritis with emphasis on available treatment regimens inclusive of primary and adjunctive therapy. Materials and Methods: The study records relevant data obtained from medical case records of patients suffering from RA above 15 yrs age excluding pregnancy and other arthritis, attending orthopedic opd at KVGMC, Sullia (D.K), Karnataka, prospectively for a period of 15-18 months starting from December, 2013 to June, 2015. Results: 217 patients suffering from RA were analyzed and recorded. RA was more common among the age group of 45 to 50 with female predominance (64%). RF positivity was seen in 42% cases. Out of 11 classes of drugs prescribed DMARDs (249), corticosteroids (225) and analgesics (217) played major role in treatment outcome. Non-biological DMARDs (94%) were more commonly prescribed, of which Methotrexate (120) & Hydroxychloroquine (128) were frequently administered. Very few patients received biological DMARDs like Etanercept and Infliximab. Both oral and IV preparations of corticosteroids were administered. Among the adjuvant group of drugs NSAIDs (130), opioids (53), Muscle relaxants (33), pregabalin (26), sedative/hypnotics (102) nutritional supplements (214), anti-gastric (201), antiemetic's (13), anti-histamines (4) were prescribed accordingly. Treatment outcome was assessed at the end of 15 months and 163 patients were relieved from symptoms but no remission but there was significant association between treatment outcome and duration of treatment with DMARDs. Conclusion: The treatment outcome and the duration of illness have significantly improved with rational use of DMARDs. Thus the study highlights and creates awareness on rational use of therapeutic agents available for treatment of RA and provides feedback to the prescriber.

RDU-4

A Study of Awareness and Knowledge About Rationality of Fixed Dose Combinations Among Residents and Interns in a Tertiary Care Hospital


Payal Naik, Sadhana Hingorani, Srivastava

Department of Pharmacology, SMIMER, Surat, Gujarat, India

Objectives: To assess the awareness & knowledge of residents and interns about rationality of fixed dose combinations (FDCs). Materials and Methods: The study was based on questionnaire given to 114 residents and 92 interns working in a tertiary care hospital. The data obtained were subjected to Chi square (X 2 ) test. Results: The residents and interns having average knowledge about irrational FDCs were 46.49% and 39.13%, respectively. Only 5.26% residents and 6.52% interns were having good knowledge about irrational FDCs. The residents and interns having average knowledge about rational FDCs were 64% and 70.65% respectively, while only 9.64% residents and 8.69% interns were having good knowledge about rational FDCs. Only 20% residents and 21.7% interns were aware about WHO approved FDCs. Majority of the residents 69.2% and interns 65.2% were aware that numbers of FDCs available are more than single drug & these are irrational. Majority of the residents and interns were having average knowledge about rational FDCs in comparison to irrational FDCs. Conclusion: The knowledge of residents and interns about FDCs is poor & they are not aware about rationality of FDCs. There is need to strictly implement teaching regarding the rationality of FDCs to medical students as per MCI regulations.

RDU-5

Prescription Pattern in Various Out-patient Departments of Maharaja's Institute of Medical Sciences, Vizianagaram Under World Health Organization Prescription Indicators


Sankarababu Gorle, Mamata Bandyopadhyay, Shilpa, Sindhura

Department of Pharmacology, MIMS, Vizianagram, Andhrapradesh, India

Objectives: World Health Organisation (WHO) prescription indicators have remained well established tool for assessment of prescription pattern and rational drug use in various health care setting. Using the same tool the prescription pattern is evaluated in present setting not done earlier. Materials and Methods: It was descriptive and cross-sectional survey type for evaluation of prescription pattern in various departments of out-patient of MIMS. The sample was selected using systematic random sampling. Total of 30 patient's prescription were enrolled for evaluation one month (1 st -31 st July, 2015). Data were retrieved from photographed prescriptions and patients were interviewed successively. Results: Contain on average were prescribed 50% of fixed drug combination among prescribed drugs. No drug was dispensed in generic name neither any injection given essential drugs contain 30% of prescriptions and 21% were prescribed anti-boitics. Interviews revealed almost whole 97% were satisfired with the time spent and the guidance need for the use of medication but only few 10%had about their diagnosis. Conclusion: The findings in all indicators showed comparable deviation from the standard set by WHO but the patient's response satisfactory. On other hand polypharmacy, generic prescribing from EDL was found to be problem in this study. Teaching hospitals have a special responsibility to society to promote rational prescribing by their staff and through them, the future generation of doctors.

RDU-6

Antibiotic Prescribing Pattern in Geriatric Patients in Medicine Wards of a Tertiary Care Hospital


Bist Ankita, Kulkarni GP, Gumma KM

Department of Pharmacology, BRIMS, Bidar, Karnataka, India

Objectives: The aim of present study is to (a) study the prescribing patterns of antibiotics administered in geriatric patients. (b) Disease conditions for which the antibiotics were prescribed and (c) adherence of these antibiotic prescriptions to the 18 th WHO essential medicine list. Materials and Methods: A prospective study was undertaken, overduration of 4 monthsat the government teaching hospital, Bidar Institute of Medical sciences, Bidar. Patients of either sex above 65 years of age admitted to medicine wards due to infections or those who acquired infection due to hospitalization and were on antibiotic treatment or prophylaxis were included. Data collection was done by scrutinizing the inpatient case sheets and investigation reports. Individual data was collected on preformed Performa. Results: Out of the 140 patients 44.2% patients were admitted for treatment of respiratory tract infections. 17.1% of the patients received antibiotics prophylactically. Cefotaxime was observed to be the most commonly prescribed antimicrobial agent. It was included in 50% of antibiotic prescriptions. It was observed that 90% of the antibiotics prescribed were in adherence to the WHO essential drug list. Conclusion: Polypharmacy is commonly observed practice in geriatric patients. Apart from increasing the cost of treatment it also promotes irrational prescription of drugs. Most of the prescriptions were in adherence with the WHO's Essential Medicine List but antibiotics were mainly prescribed empirically.

RDU-7

A Study of Prescription Pattern in Musculoskeletal Disorders Causing Low Back Pain in a Rural Teaching Hospital


Boopathy S, Vijayaraghavan S, Rajasekhar CH, Kokila BN

Department of Pharmacology, KVG Medical College and Hospital, Sullia, Dakshina Kannada, Karnataka, India

Objectives: To analyze the trend and pattern of drug prescriptions for musculoskeletal disorders causing low back pain in a teaching hospital. Materials and Methods: This observational and audit study was conducted for a period of 18 months (January, 2014 to June, 2015). Data was obtained from medical case records of patients suffering from LBP, attending the orthopaedics department in the KVG Medical College& Hospital, Sullia (D.K), Karnataka. Results: A total of 353 patients' prescription particulars were collected and analyzed, out of which 206 (58%) were males and 147 (42%) were females, the mean age being 46.28 ± 0.7. Prescription analysis showed that total number of drug formulations prescribed was 1958. The average number of drugs per prescription was 5.54. Pharmacotherapy of LBP consists of NSAIDs as the main stay of therapy (31%) followed by gastroprotective agents (18%), nutritional supplements (16%), neuroprotective agents (10%), antidepressants (9%), muscle relaxants (8%), opioids (6%) and corticosteroids (2%). DU 90% concept includes 6 classes of drugs namely NSAIDs, gastroprotective agents, nutritional supplements, neuroprotective agents, antidepressants and muscle relaxants. The test of association showed significance between choice of pharmacotherapy with duration of the disease (P < 0.05). The test of association between the pharmacotherapy and the cause of LBP was found to be significant (P < 0.05). The data analysis revealed that there was no statistically significant association between the corticosteroid therapy and the cause of low back pain (P > 0.05). Conclusion: NSAIDs as a group were the notable drugs used for the management of low back pain. Aceclofenac was the most common NSAID used. FDC usage was noteworthy. DU 90% concept in this study highlights the list of many classes of drugs the interpretation of which however, is subject to debate.

RDU-8

A Prospective Study of Off-label Use of Anti-depressant in Psychiatry Outpatient Department at a Tertiary Care Hospital


Debdipta Bose, Sushma M

Department of Pharmacology, Bangalore Medical College and Research Institute, Bengaluru, Karnataka, India

Objectives: Off-label drug prescribing is known to be very common in all medical fields including Psychiatry. Literature survey revealed only one study regarding off label use of psychotropic drugs has been conducted in Gujarat, India which includes one Antidepressant. Regular auditing and publishing of off label prescribing practices may provide strong evidence for the clinicians to use these drugs in off label manner. Hence, our objective is to evaluate the off-label use of antidepressants in Outpatient Department of Psychiatry. Materials and Methods: 6 month prospective study was conducted among patients attending Psychiatry Outpatient Department after obtaining the permission from institutional ethics committee. Demographic data and complete prescription were noted in the predesigned proforma and prescriptions were analyzed for off-label drug use as per FDA (Food Drug Administration) approved indication. Results: A total of 200 patients were enrolled with mean age 35.36 ± 12.3 years. Most common diagnosis was moderate depressive disorder 95 (40.4%). A total of 383 drugs (mean/patient 1.91 ± 0.901) were prescribed out of which 62.14% were anti-depressants. 39.1% of the anti-depressants were used as off-label indication. Antidepressants most frequently prescribed for off-label use were fluoxetine 48.38% and escitalopram 46.23%. Most common off label use was generalised anxiety disorder. There was significant correlation between off-label prescribing and number of drugs (p < 0.0001), non - depressant use (p ≤ 0.0001). Conclusion: Off label use of antidepressants was prevalent in our hospital and scientific evidence for the same is also available. More awareness can be created among the clinicians for evidence based off label drug use.

RDU-9

Assessment of Prescription Pattern of Cataract Patients in the Ophthalmology Department at a Tertiary Health Care Institution


Adhikari Karishma, Bezbaruah BK

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objectives: A hospital based study to evaluate the current prescription pattern of cataract patients in the Ophthalmology Department. To find out utilization of drugs per prescription that reflects possibilities of drug interaction and patient compliance. To suggest measures for rational prescriptions. Materials and Methods: The study was carried out in the Ophthalmology Department at Gauhati Medical College and Hospital, Guwahati for a period of 3 months after obtaining permission from the Institutional Human Ethics Committee vide letter no. MCI 2/2015/81 and Head of the Department, Opthalmology department, Gauhati Medical College and Hospital, Guwahati. This was a retrospective, observational hospital based study. The present study included patients of any age group and both the sexes (male/female) who were diagnosed as having cataract and who were prescribed different categories of drugs. Patients coming to the Ophthalmology Department who were not diagnosed as having cataract were excluded from this study. A total of 156 prescriptions were collected, analysed and classified during the study period (both outdoor and indoor patients). Results: Our study found that maximum numbers of patients were encountered in the age group of 45-65 years and around 48.4% of cases for IOL implantation were having immature senile cataract. Topical eye drops are most commonly used account for 56.3% in preoperative cases and in 67.6% cases after discharge. Overall 564 drugs were prescribed on discharge in 156 prescriptions; So on an average 3.6 drugs were prescribed per prescription. In a clear majority of patients amounting to 53.08%, 4-5 drugs were employed after discharge. Overall antimicrobials (51.80%) are most commonly prescribed group followed by anti-inflammatory (25.10%), anxiolytic, steroid etc. Conclusion: Our study showed a significant awareness to avoid polypharmacy by keeping average number of drugs per prescription as low as possible to avoid increased cost of the therapy, therapeutic failure, adverse drug reactions, drug-drug interactions and for better patient compliance. So to promote rational prescribing it is essential to conduct drug utilisation studies, educating and training the doctors adequately regarding the need for rational prescribing.

RDU-10

Assessment of Drug Use Pattern Using Who Prescribing Indicators in Medical Emergency Unit of a Tertiary Care Hospital in North East India


Deka D, Dasgupta S, Lahkar M

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objectives: Aim of the study was to assess the drug use patterns at the Emergency outpatient unit of Gauhati Medical College & Hospital, using WHO core drug use indicators. Materials and Methods: A retrospective, quantitative, and cross sectional study was conducted to determine the current prescribing practices at Emergency Outpatient unit of Gauhati Medical College & Hospital. Patient case records were collected from Medical Records Department of our Hospital and reviewed to extract data on the pattern of drug use. Results: 630 case records were reviewed retrospectively for a period of 3 months, from June 2015 to August 2015. Proton pump inhibitors, antibiotics and multivitamins were most commonly prescribed drugs. The average number of drugs prescribed per prescription was 5.4 ± 1.22 with a range between 3 and 8. There were 73.5% encounters with antibiotics, 64.6% of the drugs were given as injectables and 91% of the drugs were prescribed as generics. 94.8% drugs were from the essential drug list. Conclusion: This study shows the prescribing practices for antibiotic and injection are much higher than the standard recommended by WHO. Irrational prescription of these two costly form of drugs must be discouraged. Overuse of Proton pump inhibitors and multivitamins in emergency outpatient unit is questionable. Prescribing drugs as generics and prescribing from essential drug list have been observed to be almost satisfactory.

RDU-11

A Study on the Prescription Pattern and Use of Potentially Inappropriate Drugs in the Geriatric Clinic of a Tertiary Care Hospital in Northeast India


Shreyashi Dasgupta, Dibyajyoti Deka, Mangala Lahkar

Deprtment of Pharmacology, Gauhati Medical College, Guwahati, Assam, India

Objectives: The present study aims to investigate the prescription pattern in the geriatric patients attending the Geriatric OPD of Gauhati Medical College & Hospital, Assam and evaluate whether any inappropriate medicines are being prescribed. Materials and Methods: It is a cross-sectional prospective observational study in which the drugs prescribed to all the patients of both sexes attending the said Geriatric Clinic was studied. Results: A total of 135 prescriptions were examined out of which 81 patients were male (60%) and 54 patients were female (40%). 78 patients (57.78%) belonged to the age group 60-69 years. 55.56% patients were prescribed with 4 or more drugs. A total of 28 prescriptions out of 135 were found to contain at least one potentially inappropriate drug according to the 2012 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Conclusion: Rational drug prescription is an important part of the care of the elderly. There is a need to avoid polypharmacy and use of inappropriate drugs in our elderly population.

RDU-12

Antibiotic Utilisation Pattern in Indoor Patients of Medicine Department in a Tertiary Care Centre in Eastern India


Tithishri Kundu 1 , Pragnadyuti Mondal 1 , Suhrita Paul 1 , Nidhi Agrahari 2

1 Department of Pharmacology, Medical College, Kolkata, West Bengal, India, 2 Department of Microbiology, Vijaygarh Jyotish Ray College, Kolkata, West Bengal, India

Objectives: Misuse of antibiotics is now a well-known fact leading to the antibiotic resistance and the increasing the cost of treatment. Drug utilisation study is a proper tool to assess the grave situation of antibiotic resistance. In this literature, our objective was to study the antibiotic utilisation pattern and the appropriate usage of the generic name in Eastern India. Materials and Methods: All the prescriptions generated from Medicine IPD over a period of 2 months (June, 2015 to July, 2015) were reviewed and assessed. Antibiotic utilisation pattern and proper usage of the generic name were analysed. Results: A total of 420 prescriptions of Medicine IPD were assessed. An average number of antibiotics per prescription was 1.5. Most common oral and injectable antibiotic used were rifaximin and ceftriaxone, respectively. Most common drug for anaerobic coverage was metronidazole. 55.7% of the drugs of the total drugs were prescribed in generic name. In 43.8% of the prescriptions, all the drugs were written in generic name. In 16.7% of the prescriptions, all drugs were prescribed in the brand name. Conclusion: The study signifies that the cost of treatment is considerably lower due to adherence to the hospital supply drugs. Drugs written in the generic name is on high due to the increased awareness among clinicians. On the other hand, the presence of less number of culture and sensitivity reports indicates the negligence of the doctors and encourages the injudicious use of antibiotics, leading to the antibiotic resistance.

RDU-13

Drug Utilization Pattern of Topical Ocular Antibiotics in a Tertiary Care Hospital in Eastern India, Kolkata


Arghya Banerjee 1 , Suhrita Paul 1 , Manasi Banerjee 1 , Krishnendu Sarkar 2

1 Department of Pharmacology, Medical College, Kolkata, West Bengal, India, 2 Deprtment of Opthalmology, Medical College, Kolkata, West Bengal, India

Objectives: Irrational prescribing is a common phenomenon, seen among medical practitioners. Knowledge, awareness, and attitude denote the practicing trends amongthe practitioners. The objective of this study was to describe the prescribing practices in Ophthalmology Outpatient Department (OPD) to promote rational prescribing. Materials and Methods: This study was conducted between March 2014 to August 2015, in Department of Pharmacology and Ophthalmology. A total number of 647 prescriptions were randomly collected from the Ophthalmology OPD and were analyzed for various parameters using World Health Organization drug use indicators. Results: A total number of 647 prescriptions were evaluated for prescribing pattern, 306 (47.80%) patients were between 16-45 years of age, the male: female ratio was 1.4:1. 59% patients from lower middle class. Disease pattern observed were conjunctivitis 399 (61.66%) were most common disease. Number 436 (67.38%) patients received antimicrobial agents, fluoroquinolones (moxiloxacin, gatiloxacin, etc.), analgesics were prescribed to 151 (34.08%) patients, and 149 (33.63%) patients received antiallergics. Fixed dose combinations (FDCs) wereused in 18.89% patients, the most common combination was antimicrobials with steroids. 1.68 drug/prescription were used. Conclusion: Topical antimicrobial agents are the most commonly used drugs in ophthalmic OPD in our setup; the most common FDCs prescribed were antimicrobials with steroids, the other commonly used drugs were analgesics, carboxymethylcellulose (CMC) and anti-allergic drugs.

RDU-14

IV Ciprofloxacin Induced Chills and Rigors with a Particular Batch of Drug in Hospitalized In-patients at a Tertiary Care Teaching Hospital


Hyma Reddi, Usha Kiran, Rajeev Giri, Sunil Avagadda

Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objectives: Ciprofloxacin is acommonly used antibiotic. Chills and rigors are normally seen in only about 2% of patients receiving the drug through i.v. route. To identify drug induced chills and rigors by a particular batch number of i.v. ciprofloxacin, inhospitalized patients of a tertiary care hospital. Materials and Methods: The current study is a prospective cross-sectional observational study initiated after ethics committee approval. Patients admitted into medicine, surgery, gynecology and emergency wards who received i.v. ciprofloxacin as a part of therapywere followed for a period of two months. Medical and other pertinent records of patients were reviewed. All patients who developed chills and rigors due to i.v. ciprofloxacin were identified. Results: A total of 462 cases on IV ciprofloxacin were - registered. Among them, there were 298 males and 164 females. Chills and rigors were seen in 43 cases (9.31%). Management of ADR intervention was required in all cases. Most of the patients required substitution of treatment and 7.4% required stoppage of medication. Majority ADRs were of type A. Bulk of the ADRs were probable and possible as per WHO-UMC and Naranjo causality assessment scale in the current study. Conclusion: Chills and rigors seen by the current batch of i.v. ciprofloxacin far exceed the normal incidence. There is a need for adherence and monitoring of Good Manufacturing Practice at production sites involved in the production of i.v. ciprofloxacin. This will result in better compliance and confidence on our system of medicine and will decrease the overall health expenditure.

RDU-15

Knowledge, Attitude and Practice Among Medical and Dental Undergraduates Regarding Safe Drug Disposal Techniques


Sirisha Annavarapu, Naidu CDM, Karuna Sree

Department of Pharmacology, Kamineni Institute of Medical Sciences, Nalgonda, Telangana, India

Objectives: The concern regarding safe disposal of left over medicines is ever increasing due to their detection in environment. The present study aims to assess the drug disposal techniques among medical and dental undergraduates. Materials and Methods: The study is conducted in a tertiary teaching hospital. It is a cross sectional questionnaire based study among 469 medical and dental undergraduates. Questionnaire evaluates the attitude and practice of drug disposal and their knowledge regarding safe disposal methods. The questionnaire was tested prior to the study by conducting a pilot test and finding out Cronbach's alpha value (0.7). Time of 20 minutes was given to each student for filling the questionnaire. The students who were unwilling to fill the questionnaire were excluded from the study. Results: 469 students completed the study of which 195 are male and 274 are female. 283 students are from MBBS and 186 are from BDS. Majority of the respondents possessed around 1-5 unused drugs and the common group of drugs left over was antibiotics with dosage form being tablets. The major reason for having unused drugs wasself discontinuation after the condition resolved. According to them most practiced method of disposal was throwing in a dust bin so that municipality people collect them. Majority felt that they were unaware of consequences of improper drug disposal and the best place to teach it was at the pharmacy while dispensing drugs. Conclusion: The present study reveals poor knowledge and awareness among undergraduates regarding ecologically safe drug disposal techniques. There is increasing need to include safe drug disposal techniques among medical, dental and pharmacy curriculum. There is also increasing need of the hour to establish guidelines by the legislative authorities.

CVS

CVS-1

Evaluation of Medication Adherence and its Related Factors in Postmyocardial Infarction Patients


Satish Gonarkar, Priti Dhande, Vijaya Pandit

Department of Pharmacology, Bharati Vidyapeeth Medical College, Pune, Maharashtra, India

Objectives: (a) To find out the preventive drugs given for post myocardial infarction (b) monitoring medication adherence in these patients attending cardiac OPD (c) to reveal causes of non-adherence to drug therapy in these patients. Materials and Methods: Newly diagnosed Myocardial infarction patients were included in the study. Data collected was - patient characteristics, habits, co-morbidities and drugs prescribed. Morisky 8 item scale was used to find out the medication adherence at the end of 1 st & 6 th month. Data was analyzed using Student's paired t test, Chi square test and Logistic regression analysis. Results: Most common preventive cardiovascular drugs given were aspirin, clopidogrel and statins, 98%, 88.1%, and 90% respectively. Medication adherence at sixth month post MI was decreased compared to first month (p < 0.01). Factors associated with decreased adherence were less education (p = 0.02), housewives (p = 0.01) and low monthly income (p = 0.004). Factors which were related to good adherence were associated co-morbidities like hypertension (p = 0.01), age group of 56-65 years (p = 0.05), higher education (p = 0.04) and employees (p = 0.008). Conclusion : Medication adherence in post MI subjects of our study was seen to be reducing over six months due to factors like low monthly income and low educational status of the subjects. Employed, higher educated and those with co-morbidities showed good adherence.

CVS-2

Possible Involvement of Endothelin-Nitric Oxide Complex in Induction of Cirrhotic Cardiomyopathy in Alcohol-fed Rats


Violina Kakoty, Geetanjali Jain, Rohit Goyal

School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives: The aim of study was to investigate the possible involvement of Endothelin-Nitric oxide complex in Cirrhotic cardiomyopathy upon chronic alcohol exposure in rat. Materials and Methods: Wistar albino rats (180-240 g) were included in the study and divided into various groups (n = 5). Chronic alcohol exposure was given by administering alcohol mixed with drinking water (10.5% v/v) ad libitum for 4 weeks. L-arginine (NO precursor), LNAME (eNOS inhibitor), Aminoguanidine (iNOS inhibitor), Ambrisentan (selective ET-1 antagonist) and Vasopressin (ET-1 agonist) were given for 4 weeks. Biochemical estimations: liver enzymes: ALT, AST & ALP, cardiac enzymes (Langendorff's apparatus): LDH, CK-MB, coronary flow rate, infract size and serum NO were done. Results: A significant increase markers for liver injury: ALP, ALT & AST levels; and markers for cardiac injury: LDH and CK-MB, after chronic alcohol were observed. The administration of Alc. + L-arg. was found to potentiate the liver damage due to oxidative and nitrosative stress and release of pro-inflammatory cytokines. Administration of Alc. + VSP produced significant increase in levels of both cardiac injury markers. Whereas in case of coronary flow rate, L-arginine was found to be vasodilatory at the coronary vessels thus improving flow rate. However, in case of serum NO level, Alc. + L-arg. produced significant increase in NO level in comparison to Alc. control. Conclusion: It may be concluded that chronic alcohol intake causes cirrhotic cardiomyopathy due to hyperdynamic circulation and splanchnic vasodilation as a result of enhanced vascular resistance and oxidative stress in liver and ultimately impaired vascular hemodynamics.

CVS-3

A Drug Utilization Study of Acute Myocardial Infarction Patients in Intensive Care Unit of a Tertiary Care Teaching Hospital


Mehta DR, Singh AP, Shelat PR

Department of Pharmacology, P.D.U. Government Medical College, Rajkot, Gujarat, India

Objectives: To study drug usage, associated co-morbid conditions, and to suggest necessary measures. Materials and Methods: This prospective observational study was conducted in I.C.U from March to April 2014. 101 patients diagnosed with Acute Myocardial Infarction irrespective of age and gender was enrolled. Permission for the study was obtained from Institutional ethics committee. Details of patient's were recorded on a previously prepared case record form. Data was collected for age and gender distribution, co-morbid conditions, prescribing indicators, drug use and mean duration of stay. Analysis was done using Microsoft excel 2010. Results: Out of 101 patients 74 were male and 27 were female. M:F ratio was 3.5:1. Mean ± SD of age of patients was 54.24 ± 13.11 years. Patients with co-morbid conditions were 55. Mean ± SD of duration of hospital stay was 3.12 ± 0.94 days. Average number of drug per encounter was 12.57. Drugs given by parenteral route were 50.16%. Drugs prescribed by generic name were 60.54%. Drugs prescribed from National essential medicine list were 47.33%. Percentage of prescription containing antibiotics was 0.03%. Most commonly prescribed drugs were Enoxaparin, Heparin, Aspirin, Clopidogrel, isosorbidedinitrate, Metoprolol, Enalapril, Hydrocortisone, Pentazocin, Chlorpheniramine maleate, Streptokinase, Ranitidine. Conclusion: Polypharmacy is present with 12.57 drugs per encounter. Only 47.33% of drugs prescribed were from National list of essential medicine. Drugs prescribed by generic name are 60.54%.

CVS-4

Adherence to Treatment Guidelines in Heart Failure


Praveen Choudhary, Rohan Christian, Devang Rana, Supriya Malhotra

Department of Pharmacology, Smt. NHL MMC, Ahmedabad, Gujarat, India

Objectives: Congestive Heart Failure is the final outcome of myocardial dysfunction due to diverse etiologies. Study was aimed to analyze the prescribing pattern and to estimate the physician adherence to ACC/AHA Guidelines on Heart failure. Materials and Methods: Prescriptions of heart failure patients presenting in outpatients department (OPD) and Intensive care coronary unit (ICCU) both were recorded and analyzed. Both the quantitative and qualitative evaluation of prescription was performed using the guideline adherence index GAI-5 for five major classes of drugs. Results: Mean age of patients was 60 years. Majority of the patients belonged to NYHA class II (65.7%) in outpatients whereas in ICCU, NYHA class IV (44%) constituted majority. In OPD, antiplatelet drugs were the most frequently prescribed drug group (95.7%) whereas in ICCU it was diuretics (93.1%) drugs. Adherence to ACC/AHA guideline for drug prescription was 80% in outpatients. Deviations were in the form of underutilization of beta blockers and ACE inhibitor/Angiotensin Receptor Blocker (ARB). In ICCU adherence was only 55% to the guidelines and major deviation from adherence was again underutilization of ACEI/ARB. Guideline Adherence Index - GAI-5 for each class of drugs was out of maximum 20%. In OPD, GAI-5 for ACE Inhibitor/ARB class was 18.4%, beta blockers was 17.3. In ICCU, GAI-5 for ACE Inhibitor/ARB class was 11.2%, beta blockers was 19.4%. GAI-5 for major indicated 5 drug groups was 95.7% and 90.6% for OPD and ICCU respectively. Conclusion: The adherence to ACC/AHA guidelines was significantly more in outpatients as compared to ICCU patients. ARE/ARB were underutilised in both settings. However in our study the GAI-5 with regard to five major drug groups was high pointing to good adherence to guidelines in our prescribers.

CVS-5

Efficacy of Alternate Day Versus Daily Atorvastatin in Reduction of Low Density Lipoprotein Cholesterol: A Prospective Randomized Study


Nishikant Mankar N, Vijay Zad R, Monali Vakharia P

Department of Pharmacology, Dr. VMGMC, Solapur, Maharashtra, India

Objectives: To evaluate the efficacy and safety of alternate-day dosing of atorvastatin compared with its once-daily dose treatment. Materials and Methods: In this prospective, randomized, parallel, open labelled study, 100 participants with serum low density cholesterol (LDL-C) level >100 mg/dL were recruited. After the baseline investigations, they were randomized into two groups. Group A received 20 mg atorvastatin on alternate day and group B received 20 mg atorvastatin daily for 12 weeks. After randomization, follow up visits were scheduled at 6 and 12 weeks. At each follow up investigations like fasting serum LDL-C, serum total cholesterol, serum triglycerides, serum high density lipoproteins were estimated. Creatinine phosphokinase (CPK), serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) estimations were also done and participants were examined for occurrence of myalgia, jaundice or any other adverse effect. Results: A statistically significant reduction in LDL-C, TC, TG was seen in both the groups when compared to baseline. At 12 weeks, the LDL-C reduction in alternate day atorvastatin group (n = 49) was 34.63% whereas in daily atorvastatin group (n = 48), it was 38.75% (p > 0.05). The reduction in levels of TC in alternate day and daily atorvastatin group was 24.64% and 25.85% respectively at the end of the study (p > 0.05). Both the regimens were well tolerated and none of the patients showed significant elevation of SGOT, SGPT or CPK during the course of the study. Conclusion: The alternate-day dosing of atorvastatin is as efficacious as and a safe alternative to its daily dosing and yet inexpensive.

CVS-6

To Study the Effects of ACEI (Ramipril) on Different Biochemical Parameters in Primary Hypertensive Patients


Salve Pratibha S 1 , Salve Preeti 2 , Khanwelkar Chitra C 2 , Thorat Vandana M 2 , Purohit Abhay 2 , Sadnandan Seshla 2

1 Department of Pharmacology, KIMS, Karad, Maharashtra, India, 2 KLE University's College of Pharmacy, Belgaum, Karnataka, India

Objectives: To study effects of six months monodrug therapy with ramipril on different biochemical parameters in primary hypertensive patients. The beneficial effects of antihypertensive agents on the cardiovascular system can be counter-balanced by the induction of metabolic disorders such as hyperlipidemia, insulin resistance, etc. Recent comparative studies suggest that, for the prevention of cardiovascular events, ACEI may be superior to alternative antihypertensive agents, independently of their antihypertensive effect and metabolic abnormalities can be improved by ACEI. Therefore, this study was conducted to evaluate the effects of Ramipril on different biochemical parameters in essential hypertensive patients. Materials and Methods: 30 newly diagnosed patients of either sex with essential hypertension were included in the study. Patients having co-morbidities like diabetes mellitus, hyperlipidemia, gout, pregnant females were excluded from the study. Baseline readings of lipid profile, serum electrolytes, fasting blood sugar and uric acid were recorded before starting Ramipril drug therapy. Same biochemical tests were repeated after six months drug therapy or treatment. Results: After comparing the means there is significant decrease in triglyceride levels, highly significant decrease in LDL, uric acid, sodium and fasting sugar level and highly significant increase in HDL levels. Conclusion: Ramipril has beneficial effects on RAS and kinin system or both may contribute to the improvement by ramipril.

CVS-7

Comparison of Safety and Efficacy of Fixed Drug Combination of Amlodipine/Atenolol versus Amlodipine/Telmisartan in Hypertensive Patients


Pathania JS, Kaundal PK, Negi PC, Sahai AK

Department of Pharmacology, IGMC, Shimla, Himachal Pradesh, India

Objective: The aim of antihypertensive therapy is mainly to interrupt the progress of hypertension and lower the same below the threshold. Fixed low-dose combination therapy is a combination in a single tablet of low doses of antihypertensive agents whose mechanisms of action are complimentary. The comparative study on two fixed drug combinations viz amlodipine/atenolol and amlodipine/telmisartan will test the safety and efficacy of these two fixed drug combinations in essential hypertensive patients in North Indian population. Materials and Methods: It was a prospective, randomized, crossover, interventional study. 110 hypertensive patients willing to participate and fulfilling the study criteria's were enrolled in the study. Results: The mean fall in SBP/DBP observed was 27.16 (±11.32)/15.90 (±06.28) mmHg with Regimen 'A' (Amlodipine/Atenolol) and 32.52 (±09.32)/18.92 (±06.64) mmHg with Regimen 'B' (Amlodipine/Telmisartan) and both were statistically significant (p < 0.01). The mean change in SBP from baseline was 27.16 (±11.32) mmHg in regimen 'A' a.c.t.32.52 (±09.32) mmHg in regimen 'B' ('p' < 0.001). The mean change in DBP from baseline was 15.90 (±06.28) mmHg in regimen 'A' a.c.t.18.92 (±06.64) mmHg in regimen 'B' ('p' < 0.001). 81% of patients achieved target BP goal with regimen 'A' and 92% with regimen 'B' (p < 0.05). The total number of ADRs reported were higher in Regimen 'A' (31%) a.c.t. Regimen 'B' (11%) ('p' < 0.001). Peripheral edema was the most common ADR. Conclusion: Although, both the regimes showed efficacy in the treatment of hypertension, with Fixed Drug Combination (FDC) of Amlodipine/Telmisartan showing better efficacy, safety profile and quality of life as compared to FDC of Amlodipine/Atenolol.

CVS-8

An Experimental Study to Evaluate the Antihyperlipidemic Effect of Lercanidipine and its Comparison with Atorvastatin


Gaurav Chikara 1 , Anil Kumar Saksena 2 , Rahul Kumar 2 , Devendra Kumar Katiyar 2

1 Department of Pharmacology, AIIMS, Jodhpur, Rajasthan, India, 2 Department Pharmacology, KGMU, Lucknow, Uttar Pradesh, India

Objectives: The study was designed to evaluate the antihyperlipidemic effect of Lercanidipine and to compare it with antihyperlipidemic effect of Atorvastatin; on high fat diet induced hyperlipidemia in Wistar rats. Materials and Methods: Study was carried out in 32 male Wistar rats and all were fed on high fat diet (HFD) for initial 7 weeks. Blood samples were drawn and systolic blood pressure (SBP) was measured, both on day zero and on day 49, to confirm state of hyperlipidemia and hypertension in rats. After 7 weeks rats were divided into 4 groups, and high fat diet was further continued for 4 weeks. From eight week onwards rats were administered drugs/vehicle in following manner: Group A 1 : Distilled water (DW) only. Group A 2 : Lercanidipine 2.5 mg/kg bw orally. Group A 3 : Lercanidipine 5 mg/kg bw orally. Group A 4 : Atorvastatin 40 mg/kg bw orally. Blood samples were again drawn on day 77 for estimation of lipid profile. Also SBP was measured in Group A 1 , Group A 2 and GroupA 3 . Results: Lercanidipine in 5 mg/kg bw dose, produced statistically significant favourable mean percentage change in the post HFD mean values of total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and very low density lipoprotein (VLDL). Conclusion: So according to our study results, Lercanidipine may have therapeutic scope in dyslipidemia; particularly in dyslipidemic hypertension with mild to moderate degree of hyperlipidemia.

CVS-9

Phytochemical, Pharmacological and Toxicological Evaluation of Flower Extracts of Tecoma stans


0Narasimha Rao D, Brahmam B, Rama Rao NV, Narendra Babu A, Sathish Kumar M, Rama Rao N

Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Objectives:
The main aim of the present study is to evaluate the pharmacological profile of prepared flowers extracts for its analgesic and anti-inflammatory, anti-hyperlipidemic activities in wistar albino rat's mice. Materials and Methods: The following work was carried out in the research: (a) preparation of aqueous and ethanol extracts of dried flower of Tecoma stans flowers (Bignoniaceae) using soxhlet extraction process. (b) Investigation of preliminary phytochemical constituents of aqueous, ethanol extracts of dried flowers of Tecoma stans. (c) experimental induction of hyperlipidemia, algesia and inflammatory effects in rats & mice. (d) evaluation of anti hyperlipidemia, analgesic and anti-inflammatory effects in rats & mice. Results: The results of present study showed the presence of many phytocompounds especially phenols and proteins which were confirmed by phytochemical studies. Both the extracts were found to be safe by acute toxicity studies. Further the efficacy of ethanol flower extract of Tecoma stans was confirmed by significant analgesic (EETS 400 mg p < 0.05 vs control i.e., hot plate method & acetic acid induced writhing method), anti-inflammatory (EETS 400 mg p < 0.05 vs. control i.e., against carrageenan induced paw edema method), anti-hyperlipidemia (EETS 200 mg & 400 mg p < 0.05 vs. control i.e., against triton induced hyperlipidemia) activities compared to control, standard drug and aqueous flower extract treated animals. Conclusion: From the present study results it can be concluded that the phytocompounds from the flower extracts of Tecoma stans can yield breakthrough therapeutics.

CVS-10

Anti Hyperlipidemic, Anti-hypertensive, and Anti-inflammatory Activities of Various Extracts of Tecoma stans Leaves


Sowmya M, Divya Sri G, Narendra Babu A, Sathish Kumar M, Rama Rao N

Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Objectives: To carry out the anti hyperlipidemic, anti hypertensive and anti inflammatory activities of various extracts of Tecoma stans leaves in rats. Materials and Methods: The preclinical evaluation of standardized aqueous, chloroform and petroleum ether extracts of the leaves of Tecoma stans for various activities was carried by using the following methods. (a) Anti hyperlipidemic activity-atherogenic diet and triton induced hyperlipidemia, (b) anti hypertensive activity-fructose induced hypertension, (c) anti inflammatory activity-carrageenan induced hypertension. Results: The results obtained from the pharmacological screening have lead to the conclusions that, chloroform extract of Tecoma stans leaves have significant anti hyperlipidemic, anti hypertensive and anti inflammatory activities than the aqueous and petroleum ether extracts. Conclusion: Hence from the above study it can be concluded that phytocompounds from Tecoma stans can be exploited as a therapeutic agent or adjuvant in existing therapy for the treatment.

RSP

RSP-1

Bronchial Asthma and its Collation with Global Initiative for Asthma Guidelines in a Tertiary Care Hospital


Ruchi Shah, Shreyas Burute, Mangala Murthy, Sunita Ramanand, Praveen Patil

Department of Pharmacology, Government Medical College, Miraj, Maharashtra, India

Objectives: (1) To study prescription pattern using WHO core drug use prescribing indicators (2) To collate treatment pattern with Global Initiative for Asthma (GINA) guidelines. Materials and Methods: Patients of bronchial asthma attending the outpatient and inpatient department of medicine and paediatrics, were enrolled in the study. Prescription pattern was assessed by calculating WHO core drug use prescribing indicators. Treatment pattern was collated with recent Global Initiative for Asthma (GINA) guidelines 2014. Results: Out of 120 patients, 70 of medicine and 50 of paediatrics, most common age group was 50 and above years and 9-12 years respectively. In medicine majority were females (60%) while in paediatrics majority were males (60%). An average of 2.5 drugs was prescribed per encounter. There were 40.9% encounters with antibiotics and 44.1% with injectables. 49.4% of the drugs were prescribed as generics and 67.2% of the drugs were from National list of essential medicines (NLEM). Most common drug used was salbutamol (100%) followed by hydrocortisone (59.1%). According to GINA guidelines, 46.5% of patients belonged to mild category of severity, 44.7% of patients had uncontrolled asthma and 69.1% of patients received Step1 and Step 2 of treatment. Conclusion: Prescription pattern revealed less number of drugs prescribed as generics in medicine and less number of drugs prescribed from the National essential list of medicines 2011. Steriods, β2-agonists and Methylxanthines were prescribed most commonly. On collation with GINA guidelines it was found that though patients had mild to moderate severity of asthma but were uncontrolled and hence at risk for exacerbations.

RSP-2

Evaluation of Bronchial Smooth Muscle Relaxant Activity of Flupirtine in Experimentally Induced Asthma in Guinea Pigs


Sabreen Bashir, Kalabharathi HL, Jayanthi MK, Poornima R, Nagma Firdose, Divya Reddy

Department of Pharmacology, JSS Medical College, Mysore, Karnataka, India

Objectives: The study aimed at evaluating the broncho-relaxant effect of the test drug Flupirtine in experimentally induced Asthma in Guinea pigs & compare its efficacy with the Standard. Materials and Methods: Guinea pigs of both sexes weighing around 350-400 gms were randomly divided into 3 groups of 6 animals each. Groups were categorised into Control, Standard and test groups. Animals serving as controls received 10 ml/kg body weight of Normal saline; Standard group received 4.5 mg/kg body weight of salbutamol & the test group received the test drug flupirtine in doses of 46.5 mg/kg of body weight. All the compounds were administered once a day, per orally, through a gavage tube for 5 days. On day 5, experimental bronchial asthma was induced by exposing animals to 10% acetylcholine hydrochloride under constant pressure (40 mm/Hg) in an aerosol chamber. Animals exposed to acetylcholine aerosol developed progressive dyspnoea. Preconvulsive time (PCT) was determined from the time of exposure to onset of dyspnoea, immediately before the appearance of convulsions. Greater the PCT more is the bronchial smooth muscle relaxant effect. Results: There was a significant increase in Preconvulsive time in the test group when compared to the control group suggesting bronchial smooth muscle relaxant activity of the test drug Flupirtine. Conclusion: Flupirtine capable of mediating a reduction in contractile & inflammatory responses would be a promising drug combining bronchodilatation with anti-inflammatory action. However, further preclinical & clinical studies are warranted.

RSP-3

Prescribing Pattern of Antibiotics in Community-acquired Pneumonia in a Teaching Hospital in Eastern India


Soumya Santra 1 , Divya Agrawal 2 , Sanjay Kumar 1 ,Sudhanshu Sekhar Mishra 1

1 Department of Pharmacology, IMS and SUM Hospital, SOA University, Bhubaneswar, Odisha, India, 2 Department of Anatomy, IMS and SUM Hospital, SOA University, Bhubaneswar, Odisha, India

Objectives: To study and describe the antibiotic prescribing habits of physicians for 117 patients with community-acquired pneumonia (CAP). Materials and Methods: A medicine consultant or a pulmonologist supervised and treated 45 (38%) patients. 7 (16%) of 45 patients were given macrolide, 12 (26%) patients received beta-lactam antibiotics, 14 (31%) were given a combination of beta-lactam and macrolide and 12 (26%) patients a combination of more than one antibiotics. 72 (62%) patients were seen by other specialists, of whom 4 (6%) patients were given a macrolide, 35 (48%) of 72 patients were given a beta-lactam, a combination of beta lactam and macrolide were administered in 4 (6%) patients, 2 (3%) patients received quinolones and 26 (36%) patients received various combinations. In 47 of 117 patients, therapy was modified, which included 12 patients who underwent step-down switch. The duration of hospitalization was 26 days in those patients whose therapy was modified. Patients who underwent step down switch had a hospital stay of 7 days, whereas those who did not have any modification in treatment stayed for 10 days in the hospital. Results: Beta-lactam antibiotic was more commonly used, at least 3.8 times more than a macrolide. Other combinations of antibiotics were given in 28%, 68% and 44% of patients treated by a medicine specialist, pulmonologist and other specialities, respectively. Conclusion: These data demonstrates that in spite of the advances of knowledge in the management of community-acquired pneumonia, there exists variability in the prescribing habits of attending physician.

RSP-4

Pharmacological Screening of Various Extracts of Eclipta prostrata


Sailakshmi A, Sirisha K, Narendra Babu A, Eswar Tony D, Sathish Kumar M, Rama Rao N

Department of Pharmacology, Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India

Objectives: To carry out the preclinical evaluation of aqueous extracts of the leaves and stem of Eclipta prostrata for various pharmacological screening models. Materials and Methods: The preclinical evaluation of aqueous extracts of the leaves and stem of Eclipta prostrata for anti-asthmatic activity and anti-inflammatory activity was carried by using the following animal models: anti-asthmatic - 1. Acute airway inflammation in mice, 2. Milk induced eosinophilia in mice, 3. Anti-histaminic activity in rats, anti-inflammatory - cotton pellet granuloma in rats. Results: Anti-asthmatic and anti-inflammatory models were standardized and evaluated using leaf and stem extracts of Eclipta prostrata, and has shown a significant p value < 0.05. The test drugs were compared with both control and standard groups. The test group animals shown similar effects to that of standard group. Conclusion: According to the results of the study, the plant Eclipta prostrata extracts of leaf and stem have the medicinal value in curing asthmatic condition.

END

END-1

Study on the Anti-osteoporotic Effect of Intramuscular Injection of Vitamin D3 (Cholecalciferol) and Oral Vitamin D3 Among Vitamin D Deficient Postmenopausal Women with Osteoporosis


Afsal Muhammed, Asha S, Abdul Gafoor, Scaria Thomas

Department of Pharmacology, Government Medical College, Thiruvananthapuram, Kerala, India

Objectives: The concept of vitamin D to be considered as a prohormone, which is converted to the active hormone 1,25-dihydroxycholecalciferol (calcitriol), is widely accepted. This active hormone acts on the vitamin D receptor and brings forth several genomic and non-genomic actions. To evaluate and compare the anti-osteoporotic effect of intramuscular injection of vitamin D3 (cholecalciferol) and oral vitamin D3 among vitamin D deficient postmenopausal women with osteoporosis in terms of calcaneal bone mineral density using Ultrasound bone densitometer. Materials and Methods: Study Design - Prospective observational study. Study Setting - Department of Physical Medicine and Rehabilitation. Government Medical College, Trivandrum. Study Period - 14-02-2014 to 14-05-2015. Study procedure - Among post-menopausal osteoporotic patients (found with ultrasound calcaneal bone densitometer) with vitamin D3 deficiency, those patients who have completed treatment for vitamin D3 deficiency (either as oral vitamin d3 60,000 IU weekly for 10 weeks and continue taking oral calcium or intramuscular vitamin d3 600,000 IU single injection and continue taking oral calcium) are taken as study subjects and are evaluated for their calcaneal BMD at 3, 6, and 12 months. Results: Either of therapy did not have statistically significant change from base line at 3 and 6 months, but at the end of one year response to both therapies were found to be statistically significant in terms of BMD. (1) Intramuscular vitamin d3 therapy seems to worsen osteoporosis though not found statistically significant at 3 and 6 months and even have got case of fracture in the study group. (2) There is no significant difference between anti-osteoporotic effects of both the therapies at end of one year. Conclusion: Intramuscular large dose vitamin d3 therapy found to be ineffective as anti-osteoporotic medication in first 6 months of treatment. The results of this study has to be confirmed using RCT.

END-2

Nonadherence to Anti-diabetic Therapy and its Consequences Among Type-2 Diabetic Patients in a Tertiary Care Hospital


Veeresh J, Vasant Chavan R, Mohammad Arshad, Raghunandan M, Mohammad Faizuddin

Department of Pharmacology, Raichur Institute of Medical Sciences, Raichur, Karnataka, India

Objectives: Adherence to chronic diseases like diabetes is very low, leading to poor glycemic control and diabetes related complications in the long run. This study was done to find the level of non-adherence to anti-diabetic therapy and its consequences among type-2 diabetic patients in a tertiary care hospital in Raichur. Materials and Methods: A cross sectional observational study was done during a period of 6 months on known type-2 diabetic patients aged 18-80 yrs who were treated for at least 6 months. Patient's demographic data was collected and adherence level assessed using pretested semi structured questionnaire. Patient's present and old medical records were also reviewed for glycemic control and history of any diabetes related complications. Data thus obtained was analyzed using statistical software (SPSS version 16). Results: A total of 210 patients were recruited in the study. Incidence was more common among women (70.4%) than men (29.5%). Most of the patients were in the age group of 50-59 yrs. Only 44.7% of the patients were having good adherence to anti-diabetic therapy. Of those adherent, 87.2% had better glycemic control. Conclusion: Adherence to anti-diabetic therapy is very low but is crucial for effective glycemic control thus preventing long term complications.

END-3

Evaluation of Effect of Roflumilast on Blood Glucose Levels in Streptozotocin Induced Diabetic Albino Wistar Rats


Poornima R

Department of Pharmacology, JSS Medical College, Mysore, Karnataka, India

Objectives: To evaluate hypoglycemic effect of Roflumilast in streptozotocin induced diabetic Wistar albino rats. Materials and Methods: 18 albino rats were divided into 3 groups each group containing 6 animals, Group-1 (DIABETIC CONTROL): Distilled water 10 ml, Group-2 (STANDARD): Glibenclamide 1.35 mg, Group-3 (TEST): Roflumilast 0.045 mg/kg. A freshly prepared solution of Streptozotocin (45 mg/kg, body weight) in 0.1 ml citrate buffer, pH 4.5 was injected intraperitoneally in a volume of 1 ml/kg body weight to overnight fasted rats. After 48 hours of STZ administration, rats with moderate diabetes were selected for the experiment. A base line Capillary Blood Glucose was checked just before giving streptozotocin. All along the course of study animals will be provided with water and food adlibitum. On the 3 rd day animals were evaluated for the diabetic status by checking CBG. Only diabetic rats were used for further study. They were given above drugs for a period of 28 days starting from 3 rd day after giving streptozotocin. Blood glucose levels and body weight were measured on 0, 7 th , 14 th , 21 st & 28 th days. Results: Roflumilast has significant and sustained oral hypoglycemic activity in streptozotocin induced diabetic rats compared to diabetic control group, and also being statistically significant and comparable to the hypoglycemic effect of glibenclamide. Conclusion: These findings suggest that the hypoglycemic potential of the test compound Roflumilast is promising and found to be more significant than the diabetic control group.

END-4

Whether Metformin Influences Bone Mineral Density and Quality of Life in Postmenopausal Nondiabetic Osteoporotic Women


Kumar S, Srivastava RK, Gahlaut PS, Maggu NK

Departments of Pharmacology, Medicine and Orthopedics, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India

Objective: To determine the effects of metformin on bone mineral density changes and quality of life in post menopausal women with osteoporosis. Materials and Methods: The study was conducted in the collaboration with departments of Orthopedics and Medicine. Adequate number of the post-menopausal non-diabetic females was screened for the presence of osteoporosis. Inclusion criteria of the study were: Non diabetic postmenopausal women with osteoporosis of age group 40-65 years. 40 patients meeting inclusion criteria were divided into 2 groups, each having 20 patients. Group I: Patients were given metformin 500 mg OD orally as add on treatment for a period of 6 months. Patients of group II were not given metformin and were followed for a period of 6 months. All patients were allowed to continue their standard treatment of osteoporosis during study period. Patients were assessed at 6 months for any response on bone mineral density and quality of life and pain perception. Results: Metformin treatment in post-menopausal osteoporotic non diabetic women did not produced any additional changes in bone mineral density and was found comparable to patients who were without metformin after 6 months of treatment. BMD improved by 10% in both the groups. However, it was observed that the quality of life had improved to some extent and pain perception was decreased. Conclusion: Present study revealed no effect on bone mineral density by addition of metformin to standard anti-osteoporotic medication given for a period of 6 months. However, metformin added to anti-osteoporotic drugs there was improvement in quality of life and pain perception was decreased.

END-5

Comparative Efficacy and Safety of Ace Inhibitors and Arbs in Prevention and Progression of Diabetic Nephropathy


Richa Garg, Taruna Sharma, Minakshi Dhar, Monika Kakkar, Dhasmana DC, Shohaib Ahmed

Department of Pharmacology, Himalayan Institute of Medical Sciences, SRHU, Dehradun, Uttarakhand, India

Objectives: To compare the efficacy and safety of ACE inhibitors and ARBs in prevention and progression of diabetic nephropathy. Materials and Methods: An interventional, analytical study being conducted in the department of Pharmacology & Medicine of HIMS, Dehradun over a period of 12 months. 72 Patients fulfilling the inclusion criteria were recruited in the study by computer generated random number tables & specific baseline investigations like Serum Cystatin C, HbA1c & urinary albumin were done. Drug Ramipril 2.5-5 mg or Telmisartan 20-40 mg was prescribed once daily for a period of 3 months after which repeat investigations were done. Results: The average Pre and Post-therapy Serum Cystatin C levels for ACE and ARB were 0.95 ± 0.29 mg/dl, 0.73 ± 0.23 mg/dl and 0.91 ± 0.25 mg/dl, 0.73 ± 0.26 mg/dl, HbA1c was found to be 9.92 ± 1.94%, 9.63 ± 1.48% and 9.50 ± 1.94%, 9.82 ± 1.61% and urinary albumin levels were 154.37 ± 74.27 mg/dl, 145.99 ± 72.72 mg/dl and 150.60 ± 58.63 mg/dl, 134.89 ± 54.94 mg/dl, respectively. Conclusion: ACE and ARB were both found to be equally efficacious and safe. Post therapy Serum Cystatin C significantly declined suggestive of improved renal function in diabetic nephropathy patients.

END-6

Effects of Serankottai nei on Surgically Induced Endometriosis in Rats


Vasudha Devi 1 , Arul Amuthan 1 , Syed Musharraf 2 , Sabari Anandh 3

1 Department of Pharmacology, Melaka Manipal Medical College, Manipal Campus, Manipal University, Manipal, Karanataka, India, 2 Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal, Karanataka, India, 3 MVJ Medical College and Research Hospital, Bengaluru, Karanataka, India

Objectives: Serankottainei (S.N) is the milk extract from the nuts of Semecarpus anacardium which has proven to be having antiproliferative property. The objective of this study was to evaluate the effects of S.N on surgically induced endometriosis in rats. Materials and Methods: Endometriosis was induced in nulliparous female Wistar rats surgically by auto grafting the endometrium to the posterior abdominal wall. After 30 days, second laparotomy was done and rats with baseline adhesion score of ≥2 and cyst size of ≥150 mm 3 were divided into 2 groups (n = 6). The test group received S.N, 300 mg/kg/day and the control group received equal volume of the vehicle, olive oil for 30 days. After 30 days, rats were sacrificed and endometrial cyst size and adhesion scores were noted. Statistical analysis was done using non-parametric tests in SPSS 16. Results: The group treated with S.N showed significant reduction in endometrial cyst size (p = 0.028) compared to baseline. The control group also showed a reduction in cyst size compared to baseline, which was not statistically significant. Though there was a decrease in the adhesion scores in both the groups compared to baseline, it was not statistically significant. Conclusion: This study demonstrated the anti-endometriotic property of S.N by decreasing the cyst size. The prolonged treatment with S.N for >30 days might be explored to find out its effect on adhesion score. The isolated lead compound of this formulation might have the potential to be used as an anti-endometriotic clinically.

TOX

TOX-1

Toxicological Evaluation of Withania somnifera in Rats After 28 Days Repeated Oral Treatment


Mahboob M, Prabhakar PV, Utkarsh Reddy A, Rahman MF, Grover P

Biology Division, Toxicology Unit, CSIR-Indian Institute of Chemical Technology, Hyderabad, Telangana, India

Objectives : Withania somnifera, a well-known medicinal plant, commonly called Ashwagandha, proved to have remarkably broad range of therapeutic properties. However, studies evaluating its toxic effects are very scarce. A 28 day repeated oral toxicity study was conducted to evaluate oxidative stress inducing effect if any to certain its safe use. Materials and Methods : The present study was designed following OECD guideline 407. Withania somnifera root extract was given daily for 28 days through oral route at 30, 300 and 1000 mg/kg dose levels. Oxidative stress biomarkers were evaluated in some of the vital tissues following standard procedures. Results : The results revealed treated rats exhibited no mortality and toxic symptoms throughout the study period. It was also observed that there was no significant difference in body, organ weights and feed, water intake in treated and control rats. Withania somnifera root extract treatment also brought no significant dose related changes in lipid peroxidation, reduced glutathione content, superoxide dismutase, catalase, glutathione S transferase and glutathione peroxidase enzymes activity in liver, kidney and brain of treated rats. Conclusion : It can be concluded from the study that 28 days repeated oral treatment of Withania somnifera root extract found to be devoid of any toxic symptoms and oxidative stress effect.

TOX-2

A Study on Pattern of Acute Poisoning, Duration of Hospital Stay and its Outcome in an Emergency Department of a Tertiary Care Hospital


Vanishree, Vasant Chavan R, Mohammad Arshad, Raghunandan M, Mohammad Faizuddin

Department of Pharmacology, Raichur Institute of Medical Sciences, Raichur, Karnataka, India

Objectives: To study the pattern of poisoning, duration of hospital stay and its outcome in an emergency department of a tertiary care hospital. Materials and Methods: A retrospective observational study of 12 month duration was conducted in a teaching hospital from January, 2013 to December, 2013. Data regarding demography, name of poisonous substance, duration of hospital stay and its outcome were collected in the prestructured form. Results: A total of 384 cases of poisoning were recorded. Among these incidence was more commonly seen in males (69%) compared to females (31%) with a ratio 2.22:1. Most cases of acute poisoning presented between 21-30 year age group (49.5%). Most of the cases of acute poisoning were due to pesticides (62.8%) followed by snake bites (18.2%), drug overdosage (14.4%), corrosives (2.6%), kerosene (2%). Most of the patients were hospitalized for less than 3 days (66%). Total mortality was found to be 3.2%. Mortality rate due to OPC was significantly high compared with drug overdosage. Of the 176 patients of OPC and carbamate poisoning, 15.3% had respiratory arrest and required respiratory support. Time lapse had a significant role on the mortality in cases of acute poisoning. Conclusion: Poisoning was most commonly seen among OP compounds. The overall mortality is substantially high, mainly contributed by self-poisoning with pesticides and corrosives so proper educational and training interventions on pesticide handling and safety precautions, restriction on hazardous pesticides are needed to decrease pesticide exposure to farmers.

TOX-3

Inhibitory Effect of Probiotic Dietary Supplementation on Gentamicin Induced Nephrotoxicity in Rats


Vikas Mohan, Dipali mukerjee, Bikash Meher

Department of Pharmacology, Sri Venkateshwara Medical College Hospital and Research Centre, Ariyur, Puducherry, India

Objectives: To evaluate the protective effect of probiotic dietary supplementation on gentamicin induced nephrotoxicity in rats. To evaluate nephroprotective effect of probiotic dietary supplementation on gentamicin induced nephrotoxicity in rats. Materials and Methods : Experimental procedure - 18 male wistar rats weighing 180-200 gms were taken and allowed to adapt to new location for 1 week. Rats were divided equally among 3 groups with 6 rats in each group. Group 1 (negative control): IP saline 0.6 ml for 9 days; Group 2 (positive control): Gentamicin 100 mg/kg for 9 days; Group 3: Probiotic 500 mg/kg + gentamicin 100 mg/kg for 9 days. Biochemical analysis was done on 0 day, 5 th day and 10 th day (Blood urea nitrogen serum creatinine). Rats were sacrificed on 10 th day and kidneys were excised and sent for histopathological examination. The following changes were observed: By H & E staining, Hyaline casts in tubular lumen, Calcification, Tubular degeneration, Tubular necrosis, Mononuclear cell infiltration. Results: Probiotic has significant nephroprotective activity compared to the Group 1 (I.P. saline 0.5 ml/day) and Group 2 (Gentamicin 100 mg/kg). Conclusion: Probiotic 500 mg/kg has nephroprotective effect by the virtue of its antioxidant propertiy against gentamicin induced nephrotoxicity in rats.

GIT

GIT-1

Evaluation of Antiulcerogenic Potential of Piper betle Leaves in Experimentally Induced Gastric Ulcers in Rats


Khushboo Faldu, Gopi Patel, Jigna Shah

Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat, India

Objectives: Piper betle leaves have been reported for its antioxidant, anti-inflammatory, anti-arthritic, anti-enteropathogenic, anticancer, free radical scavenging activity, COX-1/COX-2 inhibitor, antimicrobial and antimutagenic activities. The aqueous extract is rich in hydroxychavicol which might be responsible for the activity. This study was undertaken to investigate antiulcer activity of aqueous extract of Piper betle leaves in experimentally induced gastric ulcer in rats. Materials and Methods: Wistar albino rats of either sex were treated with aqueous extract of Piper betle leaves in dose of 100 mg/kg and 200 mg/kg for 7 days p.o. once a day in Aspirin + pylorus ligation induced gastric ulcer model and 200 mg/kg in ethanol induced gastric ulcer model in rats. The physical parameters, acid secretory parameters, dissolved mucosubstances and MDA content were analyzed. Results: When compared to disease control group, Extract HC treated group showed significant decrease in ulcer index (p < 0.001), volume of gastric acid secretion (p < 0.01), total acidity (p < 0.01), total acid output (p < 0.01), pepsin output (p < 0.01) and protein content (p < 0.01), while significant increase in total carbohydrates (p < 0.01) and total carbohydrate: protein (TC:PR) ratio (p < 0.01) in Aspirin + Pylorus ligation induced gastric ulcer model. Significant decrease in ulcer index (p < 0.01) and MDA content (p < 0.001) was seen in ethanol induced gastric ulcer model in rats. Conclusion: The present study demonstrated that aqueous extract of Piper betle leaves possess significant antiulcer activity against experimentally induced gastric ulcer in rats which might be attributed to its antioxidant activity of major phytochemical constituent Hydroxychavicol.

GIT-2

A Prospective Open Labelled Study of Efficacy of Probiotic Use in Pediatric Diarrhoea


Mubishera Begum S, Usha Kiran P, Surendra Kumar G, Mohan Chandran CN

Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objectives: Acute diarrhoea is defined as more than 3 stools per day for a period of less than 14 days associated with loose stools. Most common cause of pediatric diarrhoea is viral infections and replacement of fluid and electrolyte balance is sufficient in most of the cases as standard treatment. Addition of probiotic to standard treatment is likely to improve the outcome. To study the efficacy of probiotic, Saccharomyces boulardii as add on therapy in pediatric acute diarrhoea. Materials and Methods: This is a prospective open labelled study in which 40 children (n = 40) admitted in ward, who fulfilled the inclusion criteria are randomly allocated between two groups. Standard treatment was given to one group (Group 1: n = 20) and probiotic was given along with standard treatment to other group (Group 2: n = 20). The parents were advised to mix the probiotic powder in water or milk before giving to the children. Duration of diarrhoea and consistency of stools were taken as outcome measures. Results: The results are expressed in the form of Mean ± SD. The duration of diarrhoea in standard treatment group is 5.05 ± 1.65 days and in the probiotic treated group is 4 ± 2 days. The time of appearance of first semi-liquid stools in standard treatment group is 3.25 ± 1.62 days and in the probiotic treated group is 2.0 ± 0.56 days. The results were statistically significant (p < 0.05). Conclusion: Probiotic Saccharomyces boulardii is effective in reducing duration of diarrhoea and time of appearance of first semi-liquid stools by 1 day.

GIT-3

Efficacy of Vitamin E Supplementation in Patients with Alcoholic Liver Disease: An Open Labelled, Prospective, Randomized Comparative Study


Bhanu Prakash Kolasani, Prasanand Sasidharan, Adithiya Kumar

Department of Pharmacology, Vinayaka Missions Medical College and Hospital, Kottucherry, Karaikal, Puducherry, India

Objectives: The evidence that oxidative stress is involved in the pathogenesis of Alcoholic Liver Disease (ALD) and Vitamin E deficiency being well documented in patients of ALD, this study was aimed to evaluate whether Vitamin E supplementation will be beneficial in patients with ALD. Materials and Methods: This is a prospective, open labelled, randomized comparative study of eight weeks duration, involving a total of 30 adult patients diagnosed with ALD who were randomized into two groups of 15 each and were designated as group A (received standard treatment) and group B (received Vitamin E along with standard treatment). Liver Function Test (LFT) parameters, prognostic indicators like Child Pugh Score (CPS) and Model for End-Stage Liver Disease (MELD) score and Quality of life, as assessed by Chronic Liver Disease Questionnaire (CLDQ) through its various domains were recorded before and after completing the treatment period in each group and compared. Results: In group A, the changes observed in total protein and CPS were significant (p < 0.05) and that seen in PT was highly significant (p < 0.001) whereas in group B, the changes observed in total protein, A:G ratio, total, conjugated and unconjugated bilirubin, PT and MELD score were significant (p < 0.05) and that seen in albumin, PT-INR and CPS were highly significant (p < 0.001). The changes observed in Group B CLDQ-Global score and CLDQ-SY domain score were highly significant (p < 0.001) whereas CLDQ-AB domain and CLDQ-FA domain were statistically significant (p < 0.05) compared to their respective changes observed in Group A. Conclusion: Supplementation of Vitamin E to standard treatment has minimal improvement in LFT parameters and prognostic scores but significantly improved the Quality of Life in patients of ALD as evidenced by an improvement in the CLDQ scoring.

GIT-4

Comparative Evaluation of Liv.52 ® and Sylimarin on Liver Fibrosis: A Histochemical Approach


Mohammed Azeemuddin, Mirza Rizwan Baig, Mohamed Rafiq, Jagadeesh M, Kavya KJ, Shyam Ramakrishnan

R&D Center, The Himalaya Drug Company, Bengaluru, Karanataka, India

Objectives: The objective of the study is to evaluate and compare the effect of Liv.52 ® with Silymarin in an experimental model of carbon tetrachloride (CCl 4 ) induced liver fibrosis in rats. Materials and Methods: Repeated administration of CCl 4 (0.5 ml/kg b.wt. ip.) for 8 weeks (weekly twice) resulted in a significant elevation of hepatic enzyme markers and impairment of the hepatic tissues. Results: The treatment with Liv.52 ® granules (250 & 500 mg/kg, b.wt. po.) and Silymarin granules (50 & 100 mg/kg, b.wt. po) reversed the elevated hepatic marker enzyme induced by CCl 4 and also decreased the hydropic degeneration and fibrotic changes observed in hepatic tissue to a varying extent. Treatment with Liv.52 ® and Silymarin was also found to be effective in reducing the collagen deposition in Masson's trichrome staining and also in decreasing the alpha smooth muscle actin (αSMA) expression in hepatic tissue, by immunohistochemistry (IHC). Conclusion: The results obtained indicate Liv.52 ® is more effective compare to Silymarin in reversing the biochemical and histological changes associated with CCl 4 -induced liver fibrosis in rats indicating their anti-fibrotic and anti-necrotic properties.

GIT-5

Study of Selected Antioxidants, Vitamins and Minerals Using Aspirin and Hypothermic Restraint Stressinduced Ulcer Model in Rats


Darshan Shah 1 , Nitin M 2 , Srinivasa Rao A 3

1 Department of Pharmacology, HSBPVT's GOI, College of Pharmacy, Pune University, Maharashtra, India, 2 MTR Institute of Pharmaceutical Sciences, Gulbarga, Karnataka, India, 3 Bhaskar Pharmacy College, Moinabad, Hyderabad, Andhra Pradesh, India

Objectives: This investigation is planned to explore the critical role of selected antioxidants, vitamins and minerals on gastroprotection by using Aspirin and Hypothermic restraint stress induced ulcer model in rats. To find out its safety in GI disorders along with other reference standard drugs and to recommend a safe therapy in managing gastric disorders based on preclinical studies. Materials and Methods: Albino Wistar rats of either sex weighing between 180-220 g were divided into 8 groups of 6 animals each and two models Aspirin and Hypothermic restraint stress induced ulcer modelis used for study also variousparameters like the volume and pH of gastric juice, ulcer index and percentage protection was determined. Results: All test groups Antioxidants (Vitamin E and L-cystine) & Vitamins (Thiamin and Niacinamide) & Minerals (Iron and Zinc) shows antiulcer effects. The antiulcer effects of Antioxidants (Vitamin E and L-cystine) is nearly significant with standard drug S-omiprazole and more significant than Vitamins (Thiamin and Niacinamide) & Minerals (Iron and Zinc) when compaired with positive control group. Vitamin E, Thiamin and Zinc is more significant than L-cystine, niacinamide and iron, respectively. Conclusion: it is concluded that the effect of antioxidants, vitamins and minerals are effective in treating peptic ulcer disease when compared to standard S-omiprazole alone.

GIT-6

Effect of Mangifera Indica Extract (Seed Kernel) on Cytokines and Growth Factor in Ethanol Induced Gastric Ulcer


Ankita Sharma, Chauhan I, Gautam MK, Gangwar M, Singh A, Goel RK

Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India

Objectives: To study effect of 50% ethanolic extract of M. indica seed kernel (MIE) on cytokines (IL-1β and TNF-α) and VEGF in ethanol induced gastric ulcer in rats. Materials and Methods: MIE (200 mg/kg), suspended in 0.5% CMC, was administered orally once daily for 7 days to C-F rats (150-200 g) before induction of ethanol induced GU (EtOH-GU). Ulcer index (UI), mucosal protein, cytokines (IL-1β and TNF-α) and VEGF levels were estimated. The results were compared between negative control (NS treated) and control (ethanol) as well as between control (ethanol) and ethanol + test drug/positive controls such asantisecretory drug, omeprazole (OMZ, 2 mg/kg), standard ulcer protective, Sucralfate (SCF, 500 mg/kg) and a TNF inhibitor, pentoxyphylline (PTX, 10 mg/kg). Results: Ethanol caused a significant GU compared with NS treated alone. Pre-treatment of rats with MIE, OMZ, SCF and PTX in EtOH-GU indicated significant ulcer protection which ranged from 59.6 to 78.2% (P < 0.01 to P < 0.001), respectively. Gastric mucosal tissue of CMC-NS treated rats showed protein as 59.8 ± 2.71 mg/g wet tissue while, VEGF, TNF-α and IL-1β were 147.9 ± 3.87, 815.3 ± 70.7 and 363.3 ± 32.3 pg/mg protein, respectively. CMC-ethanol treated rats did not show any change in protein content while, VEGF, TNF-α and IL-1β were increased (13.1 to 487.0% increase, P < 0.05 to P < 0.001) compared with CMC-NS treated rats. MIE, OMZ, SCF, and PTX showed little or no change in protein content, while they showed significant decrease in VEGF (11.2 to 15.3%, P < 0.05 to P < 0.01), TNF-α and IL-1β levels (20.7 to 84.1% decrease, P < 0.05 to P < 0.001) compared with control ethanol group. Conclusion: The result with acute administration of ethanol indicated increase in levels of VEGF, IL-1β and TNF-α in the gastric mucosa of rats. MIE, OMZ, SCF and PTX, causedreversal in their levels indicating the ulcer protective effects of these drugs.

GIT-7

Effect of Punica granatum extract (dried peel) on cytokines and growth factor in ethanol-induced gastric ulcer


Chauhan I, Sharma A, GangwarM,Gautam MK, Singh A, Goel RK

Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi,Uttar Pradesh, India

Objectives: To study effect of 50% ethanolic extract of P.granatum dried peel(PGE)on cytokines(IL-1β and TNF-α) and VEGF in ethanol induced gastric ulcer in rats. Materials and Methods: PGE (100 mg/kg), suspended in 0.5% CMC, was administered orally once daily for 7 days to C-F rats (150-200 g) before induction of ethanol induced GU(EtOH-GU) produced by 95% ethanol 1ml/200g, 1hr(n=6). Ulcer index (UI), mucosal protein,IL-1β and TNF-α and VEGF levels were estimated.The results were compared between negative control (NS treated) and control (ethanol) as well as between control (ethanol) and ethanol + test drug/positive controls, such asantisecretory drug, omeprazole (OMZ,2mg/kg), standard ulcer protective, Sucralfate (SCF, 500mg/kg) and a TNF inhibitor,Pentoxyphylline (PTX,10mg/kg). Results: Ethanol caused significant GU compared with NS treated alone .Pre-treatment of rats with PGE, OMZ, SCF and PTX in ethanol-induced gastric ulcers indicated significant ulcer reduction (protection) which ranged from 56.0 to 82.9 % (P<0.05 to P<0.01) respectively.Gastric mucosal tissue of CMC-NS treated rats showed protein as 54.5±1.36 mg/g wet tissue while, VEGF, TNF-α and IL-1β were 146.4±3.30, 630.7±61.7 and 391.9±38.7pg/mg protein respectively. CMC-ethanol treated rats did not show any change in protein content while, VEGF, TNF-α and IL-1β were increased (13.0 to 936.0% increase, P<0.05 to P<0.001) compared with CMC-NS treated rats.PGE, OMZ, SCF and PTX showed little or no change in their protein content while showed significant decrease in VEGF (7.49 to 13.4 %, P<0.05 to P<0.01), TNF-α and IL-1β levels(21.5 to 87.6 % decrease, P<0.05 to P<0.001) compared with control ethanol group. Conclusion: The result with acute administration of ethanol indicated increase in levels of VEGF, IL-1β and TNF-α in the gastric mucosa of rats. PGE, OMZ, SCF and PTX, caused reversal in their levels.

MIS

MIS-1

Influence of Iron Oxide Nanoparticles on Erythrocyte Photohemolysis Via Photofrin and Rose Bengal Sensitization


M-Ali H Al-Akhras 1 , Khaled Aljarrah 2 , Borhan Albiss 1 , Duaa Al-Khalili 1

1 Bio-Medical Physics Laboratory, Jordan University of Science and Technology, Irbid, Jordan, 2 College of Applied Medical Science, King Saud Bin Abdulaziz University for Health Science, Riyadh, Saudi Arabia

Objectives: Iron oxide (Fe 3 O 4 ) nanoparticles (IO-NP) were recently employed in medical applications as a diagnostic and drug carrier. Photofrin (PF) is a photosensitizer that clinically used in Photodynamic therapy (PDT). The photosensitivity of the PF and Rose Bengal (RB) mixed with (IO-NP) on red blood cells (RBCs) lysis was investigated. Second, photohemolysis for post-irradiation (delayed) and during irradiation (continuous) with PF, RB and IO-NP combinations at different concentrations was investigated. Third, the photohemolysis rate, relative lysis steepness and power-concentration dependant parameter were evaluated by modeling and fitting the data using Gompertz function and power law. Materials and Methods : RBCs were isolated from human healthy volunteers. Washed cells (7.86 X 10 6 cells/mm 3 ) were incubated with PF only or with IO-NP for 45 minutes at 37°C then irradiated to a range of temperatures (4-41°C). CPH results were recorded and evaluated using Gompertz function. Results: The relative steepness of the photohemolysis curves was approximately independent on light dose for delayed irradiation. The presence of IO-NP increases the rupturing time for 50% of the RBCs. Photohemolysis rate for delayed irradiation using the power law, led to 1.7 and 2.3 power dependence, respectively, for PF only and PF mixed with IO-NP. The power dependence of continuous irradiation measurements showed inverse proportionality of -0.32 and -0.16, respectively, for different concentrations of IO-NP combined with 2 μg/ml PF concentration and 1.5 μg/ml for RB concentration. Conclusion : Photosensitization of RBC with PF or RB mixed with IO-NP inhibited rupturing erythrocyte membrane. RB could be used as a potential natural photosensitizer and therefore it could be considered as photodynamic therapy drug substitute.

MIS-2

Linezolid Induced Exfoliative Dermatitis: A Case Report


Subhankar Choudhury, Bhulan Prasad Loc, Uma Shankar PD Keshri, Arijit Das, Rati Ranjan Debbarma, Abhishek Kumar

Department of Pharmacology and Therapeutics, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India

Exfoliative dermatitis is an inflammatory skin disease that affects nearly the entire cutaneous surface. Here, we report a case of 3 year old female baby who was suffering from painful solitary ulcer on her left thigh and was prescribed linezolid oral suspension thrice a day for 6 days. Combiflam syrup thrice a day was added for pain. Pain subsided within 3 days and Combiflam was stopped. But ulcer persisted even after day 6 and the linezolid therapy was extended for next 6 days. On the 4 th day of extension period, she suddenly developed generalized rashes with scaling, fever and pruritus. Investigations revealed eosinophilia and leukocytosis. There are two reported cases of linezolid induced DRESS (drug rash with eosinophilia and systemic symptoms syndrome). In her past she was prescribed Combiflam syrup on 3-4 occasions for fever but there was no such reaction. With Naranjo score of (+4) linezolid was suspected to be the "possible" offender.

MIS-3

Comparative Study of Curcumin Nano Particles


Poorvesh Vyas M 1 , Mihir Joshi J 2 , Ashok Vaidya B 3

1 Department of Physics, Kamani Science and Prataprai Arts College, Amreli, Gujarat, India, 2 Department of Physics, Crystal Growth Laboratory, Saurashtra University, Rajkot, Gujarat, India, 3 ICMR-Advanced Centre of Reverse Pharmacology, Medical Research Centre, Kasturba Health Society, Mumbai, Maharashtra, India

Objectives: Curcumin is famous for its antioxidant, antitumor, antiarthritic, antiamyloid, anti-ischemic, anti-inflammatory properties. It also shows good effect against malaria, cervical cancer, pancreatic cancer, colon cancer, psoriasis, etc. Curcumin is a major component in the roots of turmeric. Despite these biological activities, the usage of Curcumin is restricted because of poor bioavailability. Hence, attempts are made to develop nanoparticles of Curcumin by some researchers. The micro emulsion technique is used for synthesis of nano-particles as well as for targeted drug delivery. Materials and Methods: Curcumin nano-particles were synthesized by micro-emulsion formed by water/octaxynol-9/n-hexane. Curcumin dissolved in chloroform was used. The average particle size and morphology of the nano particles was obtained powder X-Ray Diffraction (XRD) and Transmission Electron Microscopy (TEM) and found to be 20 - 35 nm with nearly spherical morphology. The nano particles were characterized by FT - IR spectroscopy, TG - DTA - DSC. Results: From powder XRD orthorhombic crystal structure was found. The FTIR spectrum suggested the presence of various functional groups such as O-H, C-H, C=O, C=C and C-O. The thermal stability of the nano-particles was assessed from TGA and found to remain thermally stable up to 260°C. Various thermodynamic parameters were obtained from DSC. The results are explained.

MIS-4

Pharmacognostical Standardization and Assessment of Anti-inflammatory, Antioxidant and Wound Healing Potential of Rhizomes Hedychium Spicatum


0Sangeeta, Namarta, Vikas Sharma

School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives:
Pharmacognostical standardization and assessment of anti-inflammatory, antioxidant and wound healing potential of rhizomes Hedychium spicatum. Materials and Methods: Standard protocols were followed for the collection, identification of rhizomes of Hedychium spicatum. The pharmacognostical standardization was evaluated according to WHO parameters. Phytochemical screening of rhizomes was carried out. In-vitro antioxidant activity of methanolic and hydroalcoholic extracts were evaluated by radical scavenging potential using DPPH method against ascorbic acid as a standard. In-vitro anti-inflammatory activity of methanolic and hydroalcoholic extracts were carried out in terms of Inhibition of albumin denaturation test against the declofenac as a standard drug for anti-inflammatory. In-vivo wound healing activity was carried out using a hydroalcoholic extract of rhizomes of Hedychium spicatum using an incision and excision models. The marketed formulation povidone iodine was used as standard drug for the wound healing. Results: The pharmacognostical studies such as morphologic, microscopic evaluation and powder microscopy of rhizomes of Hedychium spicatum were carried out. Physicochemical constants were determined. Phytochemical investigation of hydroalcoholic and methanolic extract confirmed the presence of alkaloids, flavanoid, tannins, amino acid, saponins and triterpenoids saponins. Conclusion: Present investigation concluded that the hydroalcoholic extract of rhizomes of Hedychium spicatum gave more significant results as in-vitro antioxidant and anti-inflammatory activity as compared to the methanolic extract.

MIS-5

Production of Biocatalysts for Probiotic Carbopolymers from Lignocellulosic Biomass


Prakasham RS 1 , Ravichandra K 1 , Pradeep Kumar M 2 , Srinivas Rao P 3

1 Bioengineering and Environmental Sciences, CSIR-Indian Institute of Chemical Technology, Hyderabad, Telangana, India, 2 Chemical Engineering Division, CSIR-Indian Institute of Chemical Technology, Hyderabad, Telangana, India, 3 ICRISAT, Patancheru, Hyderabad, Telangana, India

Objectives: Development of efficient biocatalytic complex for biosynthesis of probiotic carbopolymers using hemicellulose. Materials and Methods: Different xylanase complexes produced by isolated bacterial and fungal strains were used. Birchwood and hemicellulose isolated from sorghum biomass were used as substrate material to synthesize the xylooligosaccharides which were detected either using TLC or DNS method. Results: Probiotic carbopolymers especilly, xylooligosaccharides edge over other oligomers as non-functional foods. They are potential candidates as non-cariogens, reduction of pathogenic flora, increase of minerals absorption, low caloric diet foods, anticancer agents etc. Green chemical approach is considered as the most efficient methodology. With this approach, it is possible to produce different non-functional foods such xylo-, arabinoxylo, -manoxylo-oligosaccharides, etc. Evaluation of xylanase complex for xylooligosaccharide production suggested that each xylanase complex is unique in nature and produce a complex of xylooligomers. Time dependent analysis of xylooligosaccharides production revealed that oligomer synthesis is directly proportional to reaction time. However, initial synthesis differs with the source of enzyme complex. Among the different sources of xylanases the bacterial source are effective compare to fungal enzymes in xylooligomer synthesis. The reducing sugar concentration was increased with increase of reaction time up to complete degradation of xylan. Whereas the bacterial xylanases mainly produced xylooligosaccharides in 10 hrs, after that concentration of xylose increases. Conclusions: Source dependent xylanase complex play significant role in xylooligosaccharide synthesis. Bacterial xylanases are more efficient compare to fungal for conversion of xylan to xylooligomers. Regulation of reaction time during the xylooligomer synthesis is key controlling factor.

MIS-6

A Survey of Antimicrobial Prescribing Patterns in the Surgical Wards of a Tertiary Care Hospital


Supriya U Patil, Bharti Ramchand Daswani, Ghongane BB

Department of Pharmacology, NDMVPS Medical College, Nashik, Maharashtra, India

Objectives: The rapid growth in the field of antimicrobials is complemented by an even more rapid development of resistance amongst bacteria to these antimicrobials. (1) To describe current antimicrobial use pattern in surgical wards of a tertiary care teaching hospital. (2) To evaluate appropriateness of surgical prophylaxis regimens used by surgeons at tertiary care teaching hospital. Materials and Methods: This was a prospective, observational cohort study conducted by Department of Pharmacology and Microbiology. Data was collected from 144 patients admitted to surgical wards of a tertiary care hospital in a standardized questionnaire format. A descriptive analyses was performed on demographic and clinical data so obtained to calculate %of patients who were receiving antimicrobial therapy, most frequently used antimicrobial, commonest reason for use of antimicrobials, % of patients in whom the decision to choose an antimicrobial was supported by bacteriological results, administration of surgical prophylaxis was appropriate for all parameters. This data helped to find the pitfalls in prescription of antibiotics and will be used to set up local institutional guidelines. Results: 97.92% patients received antimicrobials, of whom the decision to use an AMA was correct in 72.72% of cases and choice of first AMA administered was empirical in 88.14% of cases. Antimicrobials were switched during hospital stay in 50.39% of patients. Of all surgeries performed, use of antimicrobial prophylaxis was justified in only 82.20% cases. Conclusion: This study highlights trends in antimicrobial prescription and can be used as a baseline to educate prescribers about their rational use and avoid emergence of antimicrobial resistance.

MIS-7

Prevalence and Antimicrobial Susceptibility Pattern of Methicillin Resistant Staphylococcus Aureus in Silchar Medical College and Hospital, Assam


Devarsi Choudhury, Pinaki Chakravarty, Achinta Kumar Borthakur

Department of Pharmacology, Silchar Medical College and Hospital, Cachar, Assam, India

Objectives: Methicillin resistant staphylococcus aureus (MRSA) strains, usually resistant to several antibiotics, is a cause of concern in many countries. This study determines the prevalence and antimicrobial susceptibility pattern of MRSA in Silchar Medical College and Hospital (SMCH), Assam. Materials and Methods: This retrospective was conducted from January, 2014 to June, 2015 (1 year & 6 months) in SMCH, Assam. Four samples seen were blood, urine, pus and ear swab. Screening and confirmation of MRSA isolates were done by standard methods recommended by Clinical and Laboratory Standards Institute (CLSI). Staphylococcus aureus strains were tested for Methicillin resistance by using Oxacillin/Cefoxitin. The antibiotic susceptibility pattern of all MRSA strain was determined by Kirby-Bauer Disc Diffusion method. Results: Out of 724 positive staphylococcus strains, MRSA accounted for 311 cases (42.96%). Highest percentage of MRSA cases were from blood culture (61.68%). MRSA cases even showed resistance to other antibiotics like Cefuroxime, Amoxicillin & Clavulanic acid, Getamicin, Levofloxacin, Ciprofloxacin, Ceftriaxone, Nitrofurantoin, Amikacin, and Vancomycin. 59.50% cases of MRSA cases showed resistance to Cefuroxime. Even Methicillin sensitive strains of staphylococcus aureus (MSSA) showed resistance to antibiotics like Cefuroxime and Amoxicillin and clavulanic acid. Conclusion: The worst feature of MRSA is simultaneous drug resistance to many antibiotics. Measures preventing the spread of MRSA are to be enhanced as fewer options are available for treating MRSA. Hospital guidelines for proper antibiotics usage should be followed.

MIS-8

Comparison Between Dexmedetomidine and Propofol for Sedation in the Intensive Care Unit


Vikas Rajpurohit 1 , Mitali Dua 2 , Omi Chouhan 2 , Anusuya Gehlot 2 , Raj Kumar Rathore 2 , Ateendra Singh 2

1 Department of Anaesthesia, MDM Hospital, Jodhpur, Rajasthan, India, 2 Department of Pharmacology, Dr. S.N. Medical College, Jodhpur, Rajasthan, India

Objectives: Comparison between dexmedetomidine and propofol for sedation in the Intensive care unit. Materials and Methods: This is a prospective observational clinical study in which 40 patients, of age group (18-60 yr) who required ICU sedation, were randomly allocated; in which 20 patients were administered dexmedetomidine and remaining 20 patients were administered propofol. All these patients were observed for the period of 24 hr. Dexmedetomidine was administered by a loading dose 1 mcg/kg over 10 min, followed by a maintenance infusion of 0.2-0.7 mcg/kg/h. Propofol was started at 25 mcg/kg/min. The infusion rate was increased by increments of 5-10 mcg/kg/min until the desired level of sedation was achieved. Cardio respiratory variables; pulse-rate, respiratory rate, blood pressure (Systolic/Diastolic), and SPO2; bispectral index score (BIS); Ramsay sedation scale; recovery time from sedation and analgesic requirement were noted. Results: The cardiovascular response of patients sedated with dexmedetomidine is similar to that of patients sedated with equipotent doses of propofol, except that those receiving dexmedetomidine do not increase their heart rate. SPO 2 and respiratory rate decrease in case of propofol. The mean RSS was between 2-4 and 2-3 for Dexmedetomidine and propofol groups respectively (p > 0.05). However, patients receiving propofol infusions required rescue analgesics than patients receiving dexmedetomidine. BIS value were significantly between 40-60 in 85% of patient in dexmedetomidine group (p < 0.05). The mean time to cough buckling and extubation were lowered in dexmedetomidine group. Conclusions: Dexmedetomidine was associated with a reduction in concomitant sedative and analgesic use with minimal adverse effect as compare to propofol.

MIS-9

Preventability Predictability and Seriousness of Adverse Drug Reactions Among Pediatric Inpatients in a Tertiary Care Hospital


Karthik B, Renju S Ravi, Reneega Gangadhar, Pradeep S, Elizabeth KE

Government Medical College, Thiruvananthapuram, Kerala, India

Objectives: To assess the nature, severity, preventability, predictability and drugs implicated in ADRs. Materials and Methods: A prospective observational study was conducted in SAT Hospital, Government Medical College, Trivandrum from October, 2014 to March, 2015 (six months). All children below 12 years of age admitted with ADR or those who developed adverse drug reaction after admission in a hospital were included. A detailed history about the nature of adverse drug reaction was obtained and later causality assessment was done by using WHO scale, Severity was assessed using modified Hartwig and Siegel, Preventability using Modified Schumock and Thronton Preventability scale. Classification of ADRs was done using Rawlings and Thompsons scale. Results : ADRs were reported most commonly in Males 59%. Most of the ADRs fell under probable category 88% followed by possible 6% and certain 6%. 56% of ADR were of Moderate Severity - 26% of ADRs were mild and 18% severe. 74% of ADRs was preventable, 12% partially preventable and 14% unpreventable. Type B ADRs were predominant. Most of the ADRs were occurred due vaccines 32%, followed by antimicrobials. Skin and appendages was the most commonly involved organ with most common ADR being Rash. Conclusion : The results suggest that ADRs in pediatric patients are a significant public health issue. This study encourages more drug safety initiatives to be adopted by healthcare providers to facilitate safe and effective medication in children.

MIS-10

Comparison of Analgesic Activity of Ethanolic Extract of Two Medicinal Plants: Cleome viscosa and Averrhoea Carambola


Atifa Ahmed, Mangala Lahkar

Department of Pharmacology, Gauhati Medical College and Hospital, Guwahati, Assam, India

Objectives : To compare the analgesic activity of ethanolic extract of two medicinal plants: Cleome viscosa and Averrhoea carambola. Materials and Methods: This test was done using 20-25 gm of healthy albino mice of either sex in the Department of Pharmacology of Gauhati Medical College. They were housed in standard laboratory condition at 25°C and fed on standard diet and water ad libitum. The animals were tested for their analgesic activity by two methods: acetic acid induced writhing test and Eddy's hot plate mediated pain reaction. The animals were divided into five groups: Group I (Normal control), Group II (Standard drug), Group III, IV, V (etahnolic extract of C. viscosa and A. carrambola were given in the doses of 100, 200 and 400 mg/kg, respectively). In acetic acid induced writhing test, aspirin was taken as the standard, and number of wriths over 15 mins was calculated. In Eddy's hot plate mediated pain reaction, pentazocine was taken as the standard, and the time taken to reach the pain threshold was recorded at 30, 60, 120 mins interval. Results: Mean ± SEM values were calculated for each group. The data were analyzed using ANOVA and post analysis by Dunnett's test was done. The results confirmed the analgesic activity of both the plants, with Cleome viscosa showing slightly better activity over A. carrambola. Conclusion: Ethanolic extract of Cleome viscosa has been found to have better analgesic activity as compared to ethanolic extract of Averrhoea carambola.

MIS-11

Effect of Cellular Mobile Phone Use on Hand Eye Co-ordination and Visual Acuity in Healthy Human Volunteers as Compared with Cetirizine


Kalpita Ganpat Gawit, Smita Anand Tiwari, Gauri Hari Kasabe, Pradeep Kishanrao Deshpande, Balasaheb Baburao Ghongane

Department of Pharmacology, B.J. Government Medical College and SGH, Pune, Maharashtra, India

Objectives: This study was designed to explore the impact of the use of cellular mobile phones on parameters of alertness. This study measures variations in hand-eye co-ordination and visual acuity due to use of cellular mobile phone in comparison to that of commonly used antihistaminic drug viz. cetirizine. Materials and Methods: It was a randomized, double blind, interventional study held in BJGMC, Pune. 100 healthy human volunteers divided into two groups. Baseline readings of all volunteers were noted. Group-I (n = 50) was cetirizine group (10 mg orally stat), Group-II (n = 50) Cellular mobile phone user group. Alertness was tested on hand-steadiness tester (Reaction Time Index = RTI) and on Flicker-fusion apparatus (Visual acuity - Critical Flicker Fusion Frequency per second = CFF). Baseline readings of all volunteers were noted before intervention. Baseline was compared with readings at 3 hr post intervention. Inter-group comparison of parameters was also done. Results: The baseline RTI (92.47 ± 5.846, 85.11 ± 5.523) and CFF (41.1 ± 14.86, 41.3 ± 5.131, 40.8 ± 1.316, 40.5 + 1.395) in cetirizine group and mobile user group were comparable. The RTI is increased significantly (116.4 ± 7.278, 102.8 ± 6.966) in both the groups after intervention. However, there is no significant change in CFF from baseline in either group post-intervention. Conclusion: Use of mobile phone showed significant impairment of hand-steadiness which was comparable to that produced by cetirizine and this may be one of the factors contributing to their close association with road traffic accidents.

MIS-12

Evaluation of Safety and Efficacy of Intravenous Iron Sucrose Therapy for Moderate Anaemia in Antenatal Women


Poojitha KP 1 , Surendra Kumar G 1 , Siva Prasad KV 1 , Usha Kiran P 1 , Rajyalakshmi D 2

1 Department of Pharmacology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India, 2 Department of Obstetrics and Gynaecology, Rangaraya Medical College, Kakinada, Andhra Pradesh, India

Objectives: To evaluate the efficacy and safety of intravenous iron sucrose infusions in antenatal women admitted in hospital suffering from moderate iron deficiency anaemia. Materials and Methods: This is a prospective observational study conducted in Obstetrics and Gynaecology department, Government General Hospital, Rangaraya Medical College, Kakinada, A.P. Study period was two months and study population included antenatal women with gestational age less than 37 weeks with moderate iron deficiency anaemia. Peripheral smear was examined for microcytic hypochromic anaemia and they were treated with intravenous infusion of iron sucrose. Haemoglobin levels were checked before and 5 weeks after iron infusions. Monitoring was done for adverse reactions. Results: Out of 322 admissions, 95% were found to be anaemic. 72 patients were suffering from moderate anaemia from which 25 have been included and treated with intravenous iron sucrose infusions. They were observed for efficacy and safety parameters. Two minor adverse events were reported (fever with chills and angioedema of lips) and they were excluded from study. Mean haemoglobin concentration was found to be raised from 7.08 ± 0.73 (SD) to 11.33 ± 0.48 (SD) within 5 weeks for 23 patients. Conclusion: Iron sucrose infusion is safe and effective for anaemia in pregnancy.

MIS-13

Pharmacovigilance Programme of India: Regulatory Recommendations


Ismeet Kaur, Asmi Kumari, Kalaiselvan V, Singh GN

Indian Pharmacopoeia Commission, MoHFW, Government of India, Ghaziabad, Uttar Pradesh, India

Objectives: Pharmacovigilance Programme of India (PvPI) is playing a very important role in monitoring and signaling timely updates to CDSCO on the Adverse Drug Reactions (ADRs) reports of the drugs moving in the market. Materials and Methods: The present study was carried out at Indian Pharmacopoeia Commission (IPC) functioning as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) to evaluate the Individual Case Safety Reports (ICSRs) under various treatments during July, 2011 to March, 2015 in VigiFlow TM web-based software for International Drug Monitoring in the World health organization (WHO) Programme. The reported cases were assessed for causal relationship between the drug & event by WHO Causality Assessment Scale for signal generation. Results: Three drugs were recommended to CDSCO for regulatory action. Sunitinib Malate has been observed to cause hepatobiliary disorder, cardiovascular dysfunction, hemorrhage in Indian population suffering from metastatic renal cell carcinoma. Likewise advisory note on usage of Pazopanib Hydrochloride has been issued as it is found to cause cardiac dysfunction. Package insert to screen HLA-B* 1502 with carbamazepine induced Steven Jonson syndrome is recommended. Conclusion: Regulatory intervention for above drugs has been directed to CDSCO to caution the patients to outweigh the risk.

MIS-14

Possible Attention of Oxidative, Inflammatory and Fas Cascades: A Protective Effect of Bombax Ceiba Against Osteoporosis in Female Rats


Ankita, Shashi Chauhan, Rohit Goyal

School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh, India

Objectives: Bombaxceiba Linn. (Bombaceae) is traditionally used for the treatment of inflammation, rheumatism and dental carries and also reported to possess anti-obesity, anti-inflammatory and antioxidant activities. Lupeol is the chief constituent which is reported as fatty acid synthase (FAS) inhibitor. It is reported that FAS gene expression increases with estrogen deficiency and fatty acids have lipotoxic effect on osteoblasts. Materials and Methods: Female Wistar Albino rats (180-240 g) were employed and divided into different groups (n = 6). After the phytochemical screening of the petroleum ether and methanolic extracts, they were given at the dose of 100 and 200 mg/kg to rats for 4 weeks. Then various physical, biochemical, biomechanical and histopathological parameters were assessed. Results: Surgical ovariectomy caused significant (p < 0.05) decrease in bone density, bone strength, serum ALP, calcium and phosphorus level and increase in bone tissue destruction. Treatment with both petroleum ether and methanolic extracts produced a significant (p < 0.05) increase in bone density, bone strength, serum ALP, calcium and phosphorus level, and the restoration of the normal architecture of bone observed, as compared to OVX control. The effect produced by highest dose of both the extracts was comparable to that of tamoxifen. Conclusion: The findings from the present study may conclude that the stem bark of Bombax Ceiba has marked anti-osteoporotic effect which may be possible through FAS inhibition.

MIS-15

Evaluation of Cardiac Action of Ethanolic Extract of Nyctanthes Arbor-tristis in Isoprenaline Induced Ischemia Model of Male Wistar Albino Rat


Ankit Vataliya, Chetan Acharya, Kantharia ND, Mandakini Patel, Aashal Shah, Asif Barejia

Government Medical College, New Civil Hospital, Surat, Gujarat, India

Objectives: The objective of the study is to investigate the cardioprotective potential of the ethanolic extract of Nyctanthes arbor-tristis (NAT) in isoprenaline (ISO) induced myocardial ischemia in rats on the basis of its effects on biochemical and histological parameters. Materials and Methods: The male wistar albino rats (200-350 g) were randomly divided into four groups of 6 rats each (total 24 rats). Group I received distilled water orally for 21 days. Group II received ISO (85 mg/kg, b.w.), subcutaneously (S.C.) on the 20 th and 21 st day. Group III received plant extract (100 mg/kg, b.w.) orally by gastric gavage for 21 days and ISO (85 mg/kg, b.w.), S.C. on the 20 th and 21 st day. Group IV received NAT (300 mg/kg, b.w.) orally for 21 days & ISO (85 mg/kg, b.w.), S.C. on the 20 th and 21 st day. After 24 hours of second dose of ISO, rats were sacrificed and the levels of cardiac markers namely creatine kinase (CK-MB), lactate dehydrogenase (LDH) and antioxidant glutathione reductase (GR) were assessed in serum. Isolated heart specimens were processed for light microscopy. Results: Administration of plant extract before ISO significantly prevented ISO-induced elevation of CK-MB & LDH; also there is a significant increase in the levels of GR by higher dose of plant extract. Histopathological findings of the heart pretreated with plant extract (more by 300 mg/kg dose) revealed a well preserved normal morphology of cardiac muscle with minimal evidence of myocardial injury when compared to ISO-treated hearts. Conclusion: Pretreatment with NAT offered a protective effect against isoproterenol induced myocardial infarction in rats as evidenced by level of LDH, CK-MB and histopathological findings. This beneficial effect was mostly due to its antioxidant property as it significantly increases GR level. The results of the present investigation may trigger an interest towards the use of NAT in myocardial infarction.

MIS-16

Antinociceptive Activity of Ethanolic Neem Leaf Extract Through Opioid Pathway


Meenakshi Maurya, Yogesh Goel, Anupam Sharma, Anurag Jain, Vipin Kumar

Department of Pharmacology, S.N. Medical College, Agra, Uttar Pradesh, India

Objectives: To evaluate antinociceptive activity of ethanolic neem leaf extract (ENLE) and determine involvement of opioidergic pathway in its effect. Materials and Methods : The antinociceptive activity of ENLE was studied using hot plate method. Two different doses of ENLE (50 mg/kg and 100 mg/kg, p.o.) were administered in adult rats. Morphine (1 mg/kg, s.c.) was used as reference drug. To determine opioidergic pathway, pre-treated rats with naloxone (1 mg/kg, i.p.) were used. Results: ENLE shows antinociceptive effect in dose dependent manner. Effects were reduced in naloxone pre-treated rats. Conclusion : ENLE exhibited antinociceptive activity comparable to morphine. Involvement of opioidergic pathway is suggested.

MIS-17

A Pharmacovigilance Awareness Study Among Interns in South Indian Teaching Hospital


Ravindra Kumar G, Dhananjay K

Department of Pharmacology, KIMS, East Godavari District, Andhra Pradesh, India

Objectives: This study was aimed to analyze the baseline knowledge of awareness regarding pharmacovigilance in interns of KIMS, Amalapuram. This study also aims to get an insight into the causes of under reporting of adverse drug reactions (ADRs). Materials and Methods: It was a cross sectional study. Here participants were required to answer predesigned 25 questionnaire based onknowledge-attitude-perception (KAP) of pharmacovigilance. Completion of the questionnaire by participants was taken as their consent to participate in the study. A total of 110 participants involved in the study. Micro soft excel worksheet (2013) was used for statistical analysis. Results: Of 110 only 92 participants filled and returned thequestionnaires within the given time period. 47 (51.1%) interns experienced ADR cases during their clinical exposure, but only 22 (23.9%) of them reported it to ADR centre. Difficulty to pinpoint suspected drug was the commonest cause felt by interns for under reporting of ADR cases. Majority of interns 55 (59.7%) believed that pharmacovigilance only covers drug related problems and not any other types of ADR. Conclusion: Interns are the future doctors. Their deficiency in knowledge regarding pharmacovigilance need further attention, not only for pharmacovigilance programme success, but also for better clinical management and rational usage of drugs.

MIS-18

In vitro and in vivo anti-urolithiatic activity of Terminalia arjuna methanol extract in experimental model


Desai D 1 , Bharvalia M 2 , Parmar S 2 , Jogiya B 3 , Joshi M 3 ,Chanda S 1

1 Department of Biosciences (UGC-CAS), Pharmacological and Microbiological Laboratory, Saurashtra University, Rajkot, Gujarat, India, 2 Department of Pharmaceuticals Science (UGC-SAP), Saurashtra University, Rajkot, Gujarat, India, 3 Department of Physics, Saurashtra University, Rajkot, Gujarat, India

Objectives: Investigation of in vitro and in vivo anti-urolithiatic activity of Terminalia arjuna methanol extract in experimental model. Materials and Methods: In vitro calcium oxalate inhibition study was performed by double diffusion gel growth technique in silica gel medium using U-tube. In vivo model of urolithiasis was developed in male rats by adding ethylene glycol (EG) 0.75% in drinking water for 28 days. T. arjuna methanol extract (TABME), 150 and 350 mg/kg, p.o. were administered along with EG for 28 days in prophylactic and curative groups. 24 h urine was collected from individual rats and urine calcium, phosphate and oxalate as well as serum creatinine and uricacid levels were estimated from each animal. Results: From the in vitro study, leaf, stem and bark methanol extract had reduced the growth of calcium oxalate crystals than that of the standard drug. While in vivo study,urolithiasis caused a significant increase in both serum and urine biochemical parameters compared to healthy rats. TABME decreased levels of these parameters. Conclusions: This study, for the first time, shows in vitro crystal growth inhibition and in vivo antiurilithiatic activity of TABME against ethylene glycol modelin experimental rats. TABME was effective in both protective and curative models in experimental urolithiasis. Future work should focus on exact mechanism(s) for the antiurolithiatic action of the plant extract.




 

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