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ABSTRACTS
Year : 2011  |  Volume : 43  |  Issue : 7  |  Page : 1-41
 

Abstracts of Papers for Oral Sessions



Date of Web Publication13-Dec-2011

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How to cite this article:
. Abstracts of Papers for Oral Sessions. Indian J Pharmacol 2011;43, Suppl S1:1-41

How to cite this URL:
. Abstracts of Papers for Oral Sessions. Indian J Pharmacol [serial online] 2011 [cited 2019 Nov 14];43, Suppl S1:1-41. Available from: http://www.ijp-online.com/text.asp?2011/43/7/1/90792



  AIN  Top
AIN-1

Anti-inflammatory activity of aqueous extract of psidium guajava stem bark in albino rats and mice

V. S. Manohar , T Jayasree, R. Dixit, N. Chandrasekhar

Department of Pharmacology, Mamata Medical College, Rotary Nagar, Khammam, Andhra Pradesh, India

PSIDIUM GUAJAVA (common names-Guava, Yellow Guava) is one of the common plants used in Ayurveda. Extracts of fruit, stem-bark, leaves and roots are used in the treatment of gastroenteritis, vomiting, diarrhoea, wounds, ulcers, tooth ache, sore throat and a number of other conditions. Aqueous extract of Psidium Guajava stem bark was screened for acute anti-inflammatory activity. In rat paw edema method induced by carrageenan, the extract at the 100, 200 and 400 mg/kg dose level showed 37.5%, 42.5% and 48% (P<0.05) inhibition respectively as against 55% inhibition offered by the standard drug Diclofenac at the end of 3hrs. In the acetic acid-induced writhing method, the extract at 100,200 and 400 mg/kg dose level inhibited the writhes in mice by 17.03, 22.51 and 34.15 % (P<0.05), respectively, in comparison to the positive control group-treated with diclofenac, which inhibited the writings by 48.55%.

AIN-2

Effect of lansoprazole on acute and subacute inflammation in male wistar rats-an experimental study

*Ashutosh Shende , Hiremath SV, Torgal SS, Kangle R 1

Departments of Pharmacology and 1 Pathology, J. N. Medical College, Belgaum, Karnataka, India

*E-mail: meetashutoshonline@gmail.com


Objective: To investigate the influence of oral lansoprazole on acute and sub-acute models of inflammation in adult male Wistar rats and to compare it with control and aspirin. Materials and Methods: After obtaining ethical clearance from Institutional Animal Ethics Committee, animals were allotted to three groups i.e. control, aspirin and lansoprazole (n=6 animals in each group). The effect of lansoprazole, administered orally, on inflammation was studied using acute (carrageenan induced rat paw edema) and sub-acute (cotton pellet granuloma and histopathologic examination of grass piths) models. Experiment was conducted according to the Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA) guidelines. Analysis was done using one way ANOVA followed by Post Hoc Test of Dunnets and Bonferroni's test. P<0.05 was considered as statistically significant. Results: Lansoprazole, used orally in the present study showed significant anti-inflammatory activity in both acute as well as sub-acute models of inflammation. Conclusions: In view of role of inflammation in the pathogenesis of gastro-esophageal reflux disease, peptic ulcer disease and their complications, treatment by lansoprazole can reduce complications by virtue of its anti-inflammatory activity, in addition to its acid lowering property. Also this study may help to open new avenue for therapeutic indications of lansoprazole.

AIN-3

Comparative study of anti-inflammatory activity of withania somnifera and piperine with hydrocortisone and aspirin in albino rats

K. R. Giri , R. K. Jha, S. V. Totade, R. R. Giri, S. N. Tatkare, K. S. Kavar

Deatment of Pharmacology, J.N. Medical College, Sawangi (M), Wardha, Maharashtra, India

Objective
: To compare the anti-inflammatory property of WS and piperine with standard as Hydrocortisone and Aspirin against Carrageenan induced paw edema model in albino rats. Materials and Methods: After approval from Institutional Animal Ethics Committee, albino rats of either sex (Wt. 150-250 gms) were divided into 7 groups with 6 animals in each. Acute inflammation was produced by sub-plantar injection of 0.1 ml of 1% freshly prepared Carrageenan in normal saline in right hind paw of rats. Control groups were treated with normal saline, Test groups with Ethanolic root extract of WS (12mg/kg and 25 mg/kg p.o.) and Piperine (10 mg/kg p.o.), Standard groups with Hydrocortisone (40mg s.c.) and Aspirin (100mg/kg p.o.) one hour before Carrageenan injection. The paw volume was measured plethysmometrically at an interval of 1, 2, 3, 6 hrs after Carrageenan injection. Mean paw volume increase in ml (Mean+SE) and % inhibition of paw swelling was evaluated and analyzed statistically. Result : Mean+SE and % inhibition of paw swelling are as follows: WS at 25mg/kg 0.31+0.009, 59.2%; at 12 mg/kg 0.493+0.011, 35.08%; WS at 25mg/kg; Piperine0.325+0.012, 57.23%; Aspirin 0.3+0.006, 62.5%; Hydrocortisone 0.285+0.009, 65.3% after 3 hrs respectively.P<0.001 is significant for WS 25mg/kg, Aspirin and hydrocortisone; P<0.05 is significant for WS 12mg/kg and Piperine as compare to control group. Conclusion : WS and Piperine exhibit potent dose dependent acute anti-inflammatory activity comparable to hydrocortisone and aspirin.

AIN-4

To evaluate the analgesic activity of Moringaolifera seeds

*M. Fayazuddin, F. Ahmad, A. Kumar

Department of Pharmacology, J.N. Medical College, A.M.U, Aligarh - 202 002, Uttar Pradesh, India.

*E-mail: drmdfayazuddin@yahoo.com

Objective: Moringaoleifera commonly known as drumstick tree is the most widely cultivated species of the family, Moringaceae. Medicinal activities of Moringaoliefera are well documented. Analgesic activity of roots and other parts except seed have been well documented. There are very few studies on analgesic activity of seeds. Therefore the present study was planned to evaluate the analgesic activity of Moringaolifera seeds. Materials and Methods: The ethanolic and aqueous extracts were obtained by soxhlet apparatus. Albino wistar rats and mice were used for the study. The animals were divided into 8 groups of 6 animals each (control group-vehicle, positive control - pentazocin and 6 test groups). The analgesic activity of ethanolic (50mg\kg, 100mg/kg and 200mg/kg) and aqueous extracts (250mg\kg, 500mg/kg and 750 mg/kg) of moringaolifera seeds were evaluated using tail immersion test and eddy's hot plate test in rats for assessing central analgesic effect and acetic acid induced writhing test in mice for assessing peripheral analgesic effect. All the data was presented as mean ± S.E.M.Statistical analysis was done byone-way analysis of variance (ANOVA). P <0.05 was considered significant. Results: In tail immersion test and eddy's hot plate test both ethanolic and aqueous extracts showed significant increase in reaction time as compared to control (P<0.05). In writhing test both extracts significantly decreased the number of writhes as compared to the control group (P<0.05). Conclusion: The ethanolic and aqueous extracts of moringaolifera seeds exhibited both central and peripheral analgesic activity.

AIN-5

Efficacy of Lamotrigine, a novel anticonvulsant in phasic and tonic pain models in rodents

Saurabh Kansal , D. C. Dhasmana, Juhi Kalra

Department of Pharmacology, Subharti Medical College, Meerut, Uttar Pradesh, India

Introduction: Some anticonvulsants have been shown to be clinically efficacious in treatment of neuropathic pain and being used by clinicians. Materials and Methods : This study determined the analgesic effect of Lamotrigine (A novel anticonvulsant) in rats in different types of acute and chronic (inflammatory) nociceptive tests like Tail flick (Short duration stimuli- phasic pain model) and Formalin test (long duration stimuli- tonic pain model) having characteristic 2 phases, 1 st phase i.e. early phase reflect acute while 2 nd phase i.e. late phase denoting chronic inflammatory pain and compared its potency with a conventional non opioid analgesic Diclofenac. Results: Per oral administration of Lamotrigine produced significant antinociceptive effect in late phase of formalin test but not or negligible suppress the pain in tail flick test and also in early phase of formalin test while control drug diclofenac produced significant reduction of pain in tail flick as well as in both phases of formalin test. Conclusion: As tail flick and early phase of formalin test reflects acute pain while second phase of formalin test reflects chronic inflammatory pain, the results showing that Lamotrigine could be effective and significantly suppress the pain in various clinical condition associated with chronic inflammatory pain as Lamotrigine has been found significantly effective only in second phase of formalin test in our study.

AIN-6

Aceclofenac vs diclofenac in osteoarthritis: A comparative study of efficacy and tolerability

Pramod Reddy, J. Jyothirmai, P. Anuradha, Anandam, Rituparna Maiti

Prathima Institute of Medical Sciences, Nagunur, Karimnagar, Andhra Pradesh - 505 417, India.

Objective:
Osteoarthritis is one of the most common, chronic musculoskeletal disability and deformity in elderly patients. Non-steroidal anti-inflammatory drugs (NSAIDs) play an important role in the management of osteoarthritis. The objective of this study was to compare efficacy and tolerability of Aceclofenac and Diclofenac in the treatment of osteoarthritis patient. Materials and Methods: A randomized, open, parallel group clinical study was conducted in 140 patients of osteoarthritis. After initial clinical assessment and baseline investigations, Aceclofenac was prescribed to 70 patients and Diclofenac to another 70 patients for 8 weeks. At follow-up, the patients were re-evaluated and compared statistically. Main outcome measures were Western Ontario MacMaster scores, Time taken to walk 100 feet, Visual analogue scores for pain, Investigators assessment for Disease status and Response to therapy, Patient response to drug and Joint tenderness. Tolerability assessment was based on adverse events. Patient compliance was also assessed. Results: Aceclofenac significantly improved patients' clinical condition from baseline to day 56. Aceclofenac was found to be statistically superior to Diclofenac in efficacy parameters of WOMAC scores (P<0.0001), Joint tenderness (P<0.0001), Investigator assessment for Disease status (P=0.011) and Response to therapy (P=0.038), Patient response to drug (P=0.024). Aceclofenac was found to be statistically superior to Diclofenac in terms of epigastric discomfort, dyspepsia and abdominal pain. Compliance was also better with Aceclofenac. Conclusion: Aceclofenac is a better choice in osteoarthritis in comparison to Diclofenac due to its better efficacy and tolerability profile.

AIN-7

Randomized double blind cross over study to evaluate and compare the analgesic activity of fixed dose combination of paracetamol +diclofenac sodium and paracetamol +tramadol on different pain models in healthy volunteers

Sachidanand Tripathi , Rima Shah, D. C. Sharma

Department of Pharmacology, SBKS Medical Institute and Research Center, Piparia, Vadodara, Gujarat

Objective: To evaluate and compare the analgesic activity of fixed dose combination of Paracetamol+Diclofenac sodium and Paracetamol+Tramadol on different human pain models in healthy human volunteers. Materials and Methods: A randomized double blind cross over study was carried out in 30 healthy human volunteers using three pain models; cold water stress test, radiant heat method and BP cuff inflation method. The subjects were randomized into two groups A (Paracetamol 500 mg + Diclofenac sodium 50mg) and B (Paracetamol 375mg + Tramadol 50 mg) of 15 each. All volunteers underwent three pain models and pain threshold and pain tolerance readings were recorded at baseline and at the interval of 30, 60,120,180 minutes after drug administration. After a washout period of 7days, crossover was done and the same procedure was repeated. The results of both the study periods were analyzed using independent 't' test. Results: Mean age of the participants was 23 years and male: female ratio was 2:1. By radiant heat method, paracetamol and tramadol combination treatment showed significant increase in heat pain tolerance at 2 hrs and 3hrs (p =0.02 and 0.05 respectively) as compared with Paracetamol and diclofenac group. Other two models didn't show any significant difference in the two study drug groups. Conclusion : Paracetamol and tramadol combination was more effective than Paracetamol plus diclofenac sodium on radiant heat model. There are still major problems in the exact determination of the activated pathways and pain mechanisms in human experimental pain models but can serve as a useful tool for drug screening.

AIN-8

To evaluate the efficacy and safety of combination of tablets tolperisone and ibuprofen with tolperisone alone in patients suffering from painful muscle spasms associated with musculoskeletal disorders

*S. A. Jadhav , S. M. Doifode, M. S. Baig

Department of Pharmacology, GMC, Plot No.12, Lane No. 7. Behind Shivaji Maharaj Statue, Mukundwadi Station Road, Jai Bhavaninagar, N-4 area, CIDCO, Aurangabad, Maharashtra, India.

*E-mail: drshyamjadhav@gmail.com

Objective: To evaluate the efficacy and safety of combination of Tablet Tolperisone and Ibuprofen with Tolperisone alone in patients suffering from painful muscle spasms associated with musculoskeletal disorders, assessed by VAS score for Pain, Spasm Relief Efficacy and Reaction Time and Adverse Event reporting for safety evaluation. Materials and Methods: Total hundred patients having painful muscle spasms associated with musculoskeletal disorders were enrolled and divided equally into two groups of 50 each. One group received Tablet Tolperisone 150 mg + Tablet Ibuprofen twice daily and second group received Tablet Tolperisone 150mg daily twice daily orally for 7 days. Assessment of primary efficacy (pain intensity, spasm relief and time needed to symptoms free) was done by (0-10) using VAS score. Global assessment of efficacy was evaluated clinically. Safety assessment was done by adverse event reporting by patient, Sedation VAS score (0-10) and reaction time measurement. Results: Statisticallysignificant improvements (P<0.005) from baseline in scores for pain intensity, spasm relief were seen on days 3 and 7 in the Tolperisone + Ibuprofen group. Global assessment of efficacy favoured the combination group. Tolperisone was well tolerated with no sedation reported by any patient in both groups during study period with few events of nausea, gastric irritation. Conclusion: In this study, Tolperisone + Ibuprofen combination was more effective than Tolperisone alone and had a favourable safety profile in the treatment of painful muscle spasms. Both the treatment groups (Tolperisone + Ibuprofen and Tolperisone) were well tolerated.

AIN-9

Investigation of the anti-inflammatory potential of hydro-ethanolic extract of bambusa tulda roxb. (poaceae) shoot in rats in acute and chronic models of inflammation

Harish Rijhwani , Sudhanshu Shukla, Srinivas Rao M., Mangala Lahkar 1 , Chandana C. Baruah 2

National Institute of Pharmaceutical Education and Research (Niper), Guwahati, Assam, 1 Department of Pharmacology, Gauhati Medical College, Assam, 2 Department of Pharmacology and Toxicology, College of Veternary Sciences, Khanapara, Guwahati, Assam, India

Objectives: The aim of the current study is to study the phytochemical constituents and to investigate the anti-inflammatory potential of hydro-ethanolic extract of Bambusa tulda Roxb. (Poaceae)shoot in rats in acute and chronic models of inflammation. Materials and Methods: Different extracts of B.tulda were prepared and their phytochemical screening was done post to the TLC and HPLC analysis. Steroids, terpenoids and flavanoids were found to be the major components. Hydro-ethanolic (70:30) extract of Bambusa tulda (HEBT) obtained by maceration. The anti-inflammatory activity was studied using both acute i.e. carrageenan, dextran and histamine induced paw edema models, as well as chronic i.e. cotton pellet granuloma and Complete Freund's Adjuvant induced arthritis models of inflammation in rats. HEBT was administered at doses of 200,400, and 600 mg/kg in acute models and the two doses with more efficacy (200 and 400 mg/kg) in chronic models. Results: The extract showed a marked, dose dependent increase in anti-inflammatory activity in all the acute models of inflammation. 600mg/kg dose showed maximum inhibition of inflammation induced by carrageenan (66.14%), dextran (64.92%), and cotton pellet (31.07%) whereas 200mg/kg dose showed maximum inhibition of edema induced by histamine (63.015). Effect of 600mg/kg was prominent in CFA induced arthritis model with 51.51% inhibition of inflammation. Conclusion: From the above investigations it may be concluded that Bambusa tulda Roxb. possesses significant anti-inflammatory activity. Further characterization and isolation of the crude extract followed by in depth study is needed to identify the responsible chemical moiety (moieties) and to establish the exact mode of action


  Ans Top


ANS-1

Evaluation of antinociceptive potential of pilocarpine inAlbino rats

R. P. Bhavasar , Y. Venkata Rao

Department of Pharmacology, Kamineni, Institute of Medical Sciences, Sreepuram, Narketpally, Andhra Pradesh - 508 254, India.

Objectives : To evaluate the antinociceptive effect of Pilocarpine in three graded doses and comparing their effect with analgesic dose of Morphine. Materials and Methods : Antinociceptive effect of pilocarpine in three graded doses (1, 5, 10 mg/ kg) and morphine inanalgesic dose (1mg/kg) was evaluated by using Tail Flick Method and Tail Immersion in albino rats. Results : Pilocarpine in the doses of 5mg/kg and 10 mg/kg subcutaneous andmorphine 1mg/kg intraperitoneal produced significant (P < 0.001) antinociceptive effect incomparison to control by both tail flick method and tail immersion method. Comparison of tailflick latency and tail withdrawal latency between groups at 15, 30, 60, 90 minutes in control,morphine and pilocarpine in 5, 10 mg/ kg doses respectively, demonstrated significantdifference (P < 0.001) when compared by one way ANOVA. Morphine 1mg/kg and pilocarpine10 mg/kg did not show any significant difference in between groups (P>0.05). Conclusion : Pilocarpine in the doses of 5mg/kg and 10mg/kg demonstrated significant antinociceptiveactivity in comparison to control. Morphine 1mg/kg dose showed equipotent antinociceptiveactivity to pilocarpine 10mg/kg.

ANS-2

Evaluation of efficacy and safety of Solifenacin compared to Tolterodine in Overactive Bladder Syndrome

Kavitha S , Nagesh G, Sen T. K.

Department of Pharmacology Sri Devaraj Urs Medical College, Tamaka, Kolar

Objectives
: To compare the efficacy and safety profile of Solifenacin with Tolterodine in Overactive Bladder (OAB) Syndrome. Materials and Methods: Relevant data were collected from patients with OAB Syndrome, presenting to Department of Urology at R.L.Jalappa Hospital and Research Centre from December 2008 to May 2010. A total of 60 patients were enrolled in the study. Patients were randomized into 2 groups of 30 each to receive either oral Tolterodine 4mg or Solifenacin 10mg OD for a period of 8weeks and the patients were followed up at 2, 4 and 8 weeks and assessed for efficacy and safety of the drug. Assessment of symptom and quality of life (QOL) was done using OAB-SCS and PGI-I scale respectively at baseline and each follow up visits. Ultrasonography was done to assess the post voiding residual volume of urine. Laboratory Investigations included RBS, urine analysis, ultrasound examination of bladder and prostate, X-ray KUB and urodynamic evaluation as and when required. Results: A comparison of PVRV showed a significant reduction in residual volume with Solifenacin which was similar to Tolterodine. Solifenacin produced a greater reduction in OAB-SCS and PGI-I scores compared to Tolterodine at all follow up visits but the reduction was statistically significant only at 2 nd week. Anticholinergic side effects were infrequent and mild in nature. Conclusion: Solifenacin 10 mg once daily improved urgency and other symptoms of OAB and was associated with an acceptable level of anticholinergic side-effects in treating symptomatic overactive bladder


  Bhp Top


BHP-1

To evaluate the effect of anti-epileptics in mice models of depression

Kavita Singh , Ghongane B.B.

Department of Pharmacology, B.J. Medical College, Pune - 411 001, Maharashtra, India

E-mail: dr.singhkavita@gmail.com

Objective: Depression that is resistant to primary line of treatment is common. A number of drugs are used to augment the primary therapy. One such group is of anti-epileptics. It is however not known whether they have antidepressant activity of their own when given as a single drug therapy and their efficacy as compared to conventional antidepressants like Fluoxetine. Hence this study was designed. Materials and Methods: Swiss albino mice of either sex, weighing 20-25gms were used. Animals were divided into 15 groups of 6 each. The drugs used were Fluoxetine (20mg/kg), Gabapentin (10 and 20 mg/kg), Carbamazepine (20and40mg/kg) and Lamotrigine (20 and 40mg/kg). These drugs were used individually as well as in combination with Fluoxetine. All the drugs were given intraperitoneally. The models used were Tail Suspension Test, Forced Swimming test and Acute Restraint Induced Hypoactivity. Results: All the drugs demonstrated significant antidepressant activity as compared to placebo in Tail suspension test and Forced swimming test. However their antidepressant like activity was significantly less as compared to Fluoxetine. In Acute restraint induced hypoactivity model, Fluoxetine increased activity while Gabapentin decreased activity. The other two drugs did not affect activity significantly. Conclusion: The antiepileptic drugs Gabapentin, Carbamazepine and Lamotrigine effectively augment the antidepressant activity of Fluoxetine but their efficacy as monotherapy is less as compared to Fluoxetine alone.

BHP-2

Evaluation of antidepressant like activity of silymarin in albino mice

U. Sharma , M. Lahkar, B. Bezbarua, J. Lahon

Department of Pharmacology, Gauahti Medical College, Guwahati, Assam - 781 032, India.

Objectives: The present study was performed to evaluate the antidepressant like effect of silymarin in albino mice using forced swim test. Materials and Methods: Swiss albino mice of either sex(20-25 gm) were taken for the study. Animals were divided into 5 groups of 6 animals each. Group 1 received distilled water and served as control. Group 2 received standard drug fluoxetine (20 mg/kg,i.p); and Group 3, 4 and 5 received i.p.silymarin in doses of 200, 250 and 300 mg/kg respectively once daily for 14 consecutive days. The immobility period of control and drug treated mice were recorded in forced swim test (FST). The antidepressant effect of silymarin was compared to that of fluoxetine. Results: Silymarinat the dose of 250mg/kg and 300mg/kg significantly reduced the duration of immobility in forced swim test indicating potential antidepressant activity. Conclusions: In conclusion, the present study suggested that silymarin possessed potential antidepressant effects which could be of therapeutic interest for using in the treatment of patients with depressive disorders.

BHP-3

Evaluation of antidepressant activity of vanillin

Ahsan Shoeb , Mukta Chowta, Gokul P., Amritha Rai, Ashish Singh

Department of Pharmacology, Kasturba Medical College, Mangalore - 575 001, India

Objectives : To evaluate the antidepressant activity of vanillin in mice. Materials and Methods: Inbred adult albino mice of either sex weighing 20-30grams were used for the study. Mice were randomly assigned to five groups [Control, Imipramine 15mg/kg, Fluoxetine 20mg/kg, Vanillin 10mg/kg (V1), Vanillin 100mg/kg (V2)] of six mice each. Forced swim test (FST) and tail suspension test (TST) were the models used to evaluate antidepressant activity. All drugs were administered orally one hour before the test procedure for acute study and daily for 10days for chronic study. Duration of immobility was recorded for analysis. Kruskal Wallis Test followed by Mann-Whitney Test was used for statistical analysis of the data. Results : V2 demonstrated a significant (p<0.05) lowering of immobility duration in TST in acute and chronic study when compared to control group. In a similar fashion, the reduction of immobility by V2 was significantly (p<0.05) better in chronic TST when compared to groups receiving imipramine or fluoxetine. Conclusion : Vanillin at a dose of 100mg/kg demonstrated a significant lowering of immobility duration in TST, displaying a potential antidepressant activity.

BHP-4

Role of piracetam on cognitive function in epilepsy and with antiepileptics

S.R. Chaudhari , P.P. Dhande, V.A. Pandit

Department of Pharmacology, Bharati Vidyapeeth Deemed University Medical College, Pune - 411043, Maharashtra, India.

Objectives: 1. To study the extent of cognitive impairment caused by epilepsy and antiepileptic treatment (Topiramate and Sodium valproate). 2. To study the role of Piracetam on cognitive function in epilepsy and with antiepileptic treatment. Materials and Methods: 48 animals were divided into 6 groups: I. Control (Distilled water), II. Topiramate (2mg/100gm), III. Topiramate+Piracetam, IV. Valproate(100mg/100gm), V. Valproate+PiracetamVI-Piracetam (25mg/100gm). Baseline cognitive functions of all groups were measured by using Cook's pole climbing apparatus (CPCA) and Elevated plus maze(EPM). In CPCA, on completion of training, number of avoidances (NOA) out of 10 trials were noted. In EPM transfer latency (TL) was measured. Kindling was then induced by injecting subconvulsive dose of 30mg/kg Pentylenetetrazol (PTZ) i.p to all groups (except Group I) once every 48hrs till generalised tonic-clonic seizures were developed. Cognitive functions were recorded after induction of PTZ kindling. Then all six groups were treated with the respective drugs orally for 21 days. Cognitive functions of all groups were again measured after completion of drug treatment. Results: Data analysed by using SPSS version-19software.Significant decrease in NOA (P<0.0001) and significant increase in TL (P<0.0001) was observed after PTZ kindling. In group II, Topiramate further significantly impaired NOA (P<0.0005) and TL (P<0.0005) after PTZ kindling. Whereas in group IV after PTZ kindling, Valproate further significantly reduced NOA (P=0.001) in CPCA but increase in TL was not significant in EPM. Treatment with Piracetam significantly increased Topiramate (P=0.001), Valproate(P=0.02) and PTZ kindling (P=0.001)induced decrease in NOA. Also Piracetam significantly reduced Topiramate (P=0.001) and PTZ kindling (0.008) induced increase in the TL. Conclusion: Seizures are associated with cognitive impairment. Cognitive impairment caused by Sodium valproate is less as compared to Topiramate. Piracetam, a known nootropic can be used in alleviating cognitive impairment associated with epilepsy and chronic antiepileptic therapy.

BHP-5

Antidpressent effect of extract of mucuna pruriens seeds

Hirulkar A. S. , Namburi S., Adhaoo P. S., Tenpe C. R., Patole A. M., Tundulwar M. R. Akshay S. Hirulkar

Department of Pharmacology, Institute of Pharmaceutical Education and Research, Borgaon (Meghe), Wardha - 442 001, Maharashtra, India

Objective: To evaluate the antidepressant effect of ethanolic extract of Mucunapruriens seeds.Depression is a state of low mood and aversion to activity that can affect a person's thoughts, behavior, feelings and physical well beings. It is currently the leading cause of non-fatal disability in world. Mucunapruriens is a tropical legume known as velvet been has a range of medicinal properties including antiparkinson, aphrodisiac, antivenom and diuretic. It contains serotonin, L-DOPA and histamine. Presence of serotonin made it to hypothesize that Mucunapruriensseed extract will show antidepressant activity. Materials and Methods: The shade dried and powdered seeds of Mucunapruriens were subjected to cold maceration with ethanol and extract was administered to albino mice (Wistar strain) weighing 18-25 gm in the doses of 600, 800, 1000, 1200 mg/kg (p.o.). Antidepressant activity was evaluated using Chronic Unpredictable Mild Stress (CUMS) procedure, Forced Swim Test (FST) and Open Field Test (OFT). Results: The ethanolic extract (1200 mg/kg) of Mucunapruriensseeds was found to restore sucrose consumption and body weight significantly in CUMS. In FST, the immobility time was remarkably decreased in doses of 1200 mg/kg and in OFT, number of grooming was increased and locomotor activity and rearing were remarkably improved. Conclusion: The present study confirms the antidepressant like effect of ethanolic extract of Mucunapruriens. This finding suggest that Mucunapruriens is worthy of further investigation as a potential antidepressant.

BHP-6

Agmatine facilitates impaired spatial learning in diabetic rats

Faldu D.S. , Aglawe M.M., Taksande B.G., Kotagle N.R., Ugale R.R., Chopde C.T.

Division of Neuroscience, Department of Pharmacology, Smt. Kishoritai Bhoyar College of Pharmacy, New Kamptee, Nagpur - 441 002, Maharashtra, India.

Objective: To evaluate the effect of agmatine on impaired spatial memory in type II diabetic rat. Materials and Methods: Type II Diabetes Mellitus (T2DM) in rats was induced by giving high fat diet (HFD) for 14 days followed by streptozotocin (STZ) injection (35 mg/kg i.p) and induction was confirmed by elevated plasma glucose, total cholesterol and total triglyceride level as a biochemical marker of T2DM. Diabetic rats were administered intra-hippocampally (AP 3.8, L 2.2, V 2.7) either with aCSF, insulin (1 or 6 mU/rat) or agmatine (10 or 20 μg/ rat) or their combinations either 24 hrs or 10 min before evaluation of spatial memory in morris water maze. Results: Rats given HFD for 14 days followed by STZ injection were shown to have impaired memory in morris water maze as indicated by decreased no. of entries and time spent in platform quadrant, decreased number of crossings over platform and increased escape latency. Intra-hippocampal agmatine (10 or 20 μg/rat) or insulin (6 or 12 mU/rat) facilitated memory consolidation and retrieval in rats. Agmatine (10 or 20 μg/rat) significantly facilitated spatial memory in high fat diet treated rat while insulin was ineffective. However the combination of agmatine and insulin synergistically improved the spatial memory in HFD treated diabetic rats. Conclusion: Agmatine improved spatial memory in HFD treated type II diabetes rats and can be projected as a novel therapeutic strategies for memory impairment in type-II Diabetes Mellitus.


  Chm Top


CHM-1

Assessment of efficacy and safety of artesunate plus sulfadoxine- pyrimethamine combination for treatment of uncomplicated falciparum malaria

Goyal Yash N. , Bhansali Nishant B., Singh Anil

Department of Pharmacology, Shri. M. P. Shah Medical College, Jamnagar, Gujarat - 361 008, India.

Objective: To determine the efficacy and safety of AS+SP in patients with uncomplicated falciparum malaria. Materials and Methods: The study included 60 patients of uncomplicated plasmodium falciparum. Every patient received AS+SP as per WHO guidelines. Diagnosis was confirmed by peripheral blood film.All patients were followed-up on Days 1, 3, 14, 28 for detailed clinical and parasitological examination. Results and Conclusion: Total of 55 patients were followed up for 28 days. Remaining 5 patients were lost in follow up. As per protocol analysis 91% (50) of patients had demonstrated Adequate Clinical and Parasitological Response (ACPR). Remaining 9% (5) had treatment failure in which 5.5% (3) had Late Parasitological Failure (LPF) and 3.6% (2) had Late Clinical Failure (LCF). In our study mean parasite clearance time was 45.2 ± 4.2 hrs. AS+SP is safe and effective drug for the treatment of uncomplicated falciparum malaria. But the efficacy of this ACT needs to be carefully monitored periodically since treatment failure can occur due to resistance.

CHM-2

Pattern of adverse drug reactions due to cancer chemotherapy in tertiary care teaching hospital in Gujarat.

Solanki K.C.* , Goyal Y.N., B. Divakar, Singh A., Trivedi H.R.

Department of Pharmacology, M. P. Shah Medical College, Jamnagar, Gujarat - 361 008, India.

Objectives: The aim of present study was to assess the incidence of adverse drug reaction of cancer chemotherapeutic drugs in dept. of radiotherapy in tertiary care hospital Jamnagar. Materials and Methods: A prospective, observational study was carried out for duration of twelve months (July 01, 2010 to June 30, 2011). All the patients who underwent cancer chemotherapy at the radiotherapy department of G.G.hospital, Jamnagar and during the study period were included. Cases that were unlikely, conditional or unassessible under WHO-UMC causality criteria were excluded. Clinical and treatment data were collected from the inpatient case records. CDSCO forms were used to record the ADRs. Causality, severity and preventability were assessed by WHO causality assessment scale, Hartwig and Siegel scale and Shumock and Thornton scale respectively. Result: Among the 229 patients 105 (45.85%) patient developed ADR, among them 57 male (54.29%) and 48(45.71%) female patients developed ADRs. Total 199 ADRs noted among 105 patients. Most of ADRs were vomiting 44(41.90%), alopecia 41 (39.05%) and myelosupression 38 (36.19%). Platinum 57 (54.29%), antimetabolites 50 (48.71%) and taxanes 31 (29.52%) were mostly responsible for ADRs. Most of the ADRs were "possible" 78 (39.19%), followed by "certain" 66 (33.17%) and "probable" 55(27.64%) in WHO causality assessment scale. Hartwig and Siegel severity scale shows "moderate"106 (53.26%) followed by "mild" 62 (31.16%) and "severe" 31 (15.58%) ADRs. Shumock and Thornton scale shows 171(85.93%) were "not preventable" and 28(14.07%) were "preventable". Conclusion: Early detection of drug toxicity helps to treat the patient and modify the doses or the drug regimen to minimize toxic effects.

CHM-3

Study of sputum conversion in smear positive pulmonary tuberculosis patients after intensive therapy under dots regimen

Rashmi R. Rao , Roopa P. Nayak, Mohandas Rai, Akshaya Alva, Ashwini Mandanna N.

Department of Pharmacology, A. J Institute of Medical Sciences, Mangalore - 575 004, Karnataka, India.

Objective: To study the sputum conversion rate in new smear positive (NSP) and retreatment cases of tuberculosis in Mangalore tubercular unit, Dakshina Kannada. Materials and Methods: A retrospective study was conducted at District TB centre in Mangalore. The medical records of 378 patients treated under category 1 and category 2 from year 2009-2010 were analysed. The data with regard to age, gender, category of treatment, residence, sputum results during various stages of treatment were recorded. Sputum conversion rate for NSP (CAT 1) patients who converted from positive to negative state at the end of intensive phase (2month) and at the end of extended intensive phase (3month) were calculated. For retreatment patients (CAT 2) sputum conversion rate was calculated at the end of intensive phase (3month). Results: Among 253 NSP patients 207 converted from positive to negative state with the sputum conversion rate of 82%. Among 125 retreatment patients 63 converted with sputum conversion rate of 50%. Conclusion: In the above study the sputum conversion rate in CAT 1 was significant when compared to CAT 2 with the first line anti tubercular drugs. One of the reasons for the low conversion rate under CAT 2 could be due to development of resistance to any of the first line anti tubercular drugs. Therefore it necessitates the need for early culture and sensitivity.

CHM-4

Clinical efficacy of topical terbinafine versus topical luliconazole in treatment of tineacorporis/tineacruris patients

Vidhya Lakshmi C.P. , Kumar T.N., Shiva Kumar

No:-4, 'A'Block, "AnnaiIllam", Pipe Lane, Robertsonpet, Kolar Gold Field - 563 122, India.

Objective: To compare the clinical efficacy between topical Terbinafine and topical Luliconazole on Tineacorporis / Tineacruris patients. Materials and Methods: Study was conducted on 60 patients presenting to Dermatology OPD of Sri RL Jalappa Hospital, Kolar,both as in and out patient basis from January 2011 to August 2011During this period,they were alternatively assigned to either of Group A:-topical Terbinafine and Group B:-topical Luliconazole and they were advised to apply medications for 14days. Clinical symptoms and signs were assessed using 4-point scale and KOH mount performed at first visit[base line],end of treatment visit[14 th day] and later 30 th day. The data was analysed for age, sex,d uration of lesion,score pattern and KOH mount. Results : Of the 60 patients recruited, all were available for 1 st follow up [14 th day] and 51 patients available for 2 nd follow up [30 th day]. All 51 patients were negative for KOH mount preparation on 14 th and 30 th day. Conclusion : Both Terbinafine and Luliconazole were equally effective in treating Tineacorporis/Tineacruris patients.

CHM-5

Evaluation of efficacy of 5- Fluorouracil, Doxorubicin, Cyclophosphamide versus 5- Fluorouracil, Doxorubicin, Cyclophosphamide and Paclitaxel for node positive breast cancer in a secondary care hospital

Anjana Mohan , S. Ponnusankar

Department of Pharmacy Practice, JSS College of Pharmacy, Ootacamund.

Objective: To compare the efficacy of FAC and FAC followed by Paclitaxel in node positive breast cancer. Materials and Methods: An open label study was conducted in 24 node breast cancer patients to receive 6 cycles of FAC ( Inj. 5-Fluorouracil 500mg/m 2 , Inj. Doxorubicin 50mg/m 2 , Inj. Cyclophosphamide 500mg/m 2 ) or 6 cycles of FAC+4 cycles of Paclitaxel (Inj. Paclitaxel 225mg/m2) in every 21 days. Patients should not have distant metastasis with Karnofsky performance score >70%. Paired sample T test was done to evaluate recurrence rate and disease free survival, Kaplan meier analysis evaluated the time to progression. Results: Recurrence rate was found by comparing the treatment with end reports and staging with end reports. Significant difference (p<0.05) was seen in the comparison of the first and end reports of chest x- ray during stage 3b. It shows that disease progression i.e. lung metastasis was seen more in the stage 3b.The disease free survival was evaluated between then baseline and after 2 months of the chemotherapy. The results concluded that there is a significant difference (P<0.05) in the patients treated with FAC regimen. Time to progression did not show significant difference (P<0.01) in the two treatment groups. Conclusion: In locally advanced breast cancer adjuvant Paclitaxel to FAC is the drug of choice as compared with FAC alone. Recurrence was noted in some patients treated with FAC during stage 3b indicating the negative impact of FAC in the locally advanced breast cancer, the disease free survival event was augmented in FAC treated patients.

CHM-6

Efficacy profile of bortezomib in treatment of patients with refractory multiple myeloma

*Deshmukh G.A. , Baig M.S., Razvi S.U., Doifode S.M.

Department of Pharmacology, Government Medical College and Hospital, Panchakki Road, Aurangabad, Maharashtra - 431 001, India. *E-mail: drgaurav0@gmail.com

Objective: To evaluate the efficacy profile of Bortezomib in patients with multiple myeloma who have relapsed on previous therapy. The end points used were overall response rate (primary end point), the progression-free survival (PFS), the overall survival (OS), the duration of response (DR) and toxicity profile (second end points). Materials and Methods: We conducted a prospective, observational study of 21 consecutive cases of refractory MM treated with Bortezomib and dexamethasone as a second line therapy, from September 2010 to September 2011. Cancer patients suffering from refractory Multiple Myeloma, attending Department of Radiotherapy and Oncology, GMC Aurangabad were included in the study. Bortezomib 1.3 mg/m2 was given on days 1, 4, 8, and 11 according to scheduled treatment along with dexamethasone 20 mg was given on days 1-4 and 15-18. Further they were analyzed on the basis of PFS, OS and DR. Results: In our study we found an overall response rate of 70%. With a median follow-up of 15 months, we had a median PFS of 12 months (95% CI: 2-21 months), with a median OS of 17 months (95% CI: 2-32 months), and a median DR of 9 months (95% CI: 5-13 months). Forty-seven percent of patients had neuropathy, the 17% thrombocytopenia, 13.33% anemia and 26.66% diarrhea. Conclusions: Multiple Myeloma is a tumour of plasma cells with high relapse rates. We found that the combination of Bortezomib and Dexamethasone proved not only to be efficacious for the treatment of refractory MM, but also with a manageable toxicity profile.


  Clp Top


CLP-1

Self medication in primary dysmenorrhea - A survey

Ramya S. , Vasundara K.

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

Objective : With limited data available on self medication for primary dysmenorrhoea in Indian population, the present study was conducted to evaluate the pattern and compare the efficacy and tolerability of the self medicated drugs in primary dysmenorrhea. Materials and Methods: The survey was conducted in various educational institutions using a self-developed validated objective structured questionnaire. Results: 641 completely answered questionnaires were included for the study. Among them, 267(41.6%) self medicated.50 (18.7%) self medicated for mild,133(49.8%) for moderate and 84 (31.5%) for severe pain. 70 (26.2%)used mefenamic acid, 95(35.6%) used dicyclomine, 23(8.6%) used a combination of mefenamic acid +dicyclomine, and 79(29.6)% did not know the name of medication they consumed. 78(29.2%) were aware of side effects, with nausea, headache, abdominal pain and dizziness observed in 46.1%, 23.8%,20.6% and 9.5% respectively. The statistical analysis was done using SPSS 19 version. ANOVA with post-hoc Tukey test and Chi square test were applied. Conclusion: Our study shows that though self medication is common in primary dysmenorrhea (P=0.0001), there is lack ofawareness about drug choice and side effects (P=0.001).Mefenamic acid and mefenamic acid +dicyclomine combination is equally more efficacious than dicyclomine alone (F=3.59, P<0.05), although dicyclomine was most commonly used. The combination of mefenamic acid+ dicyclomine is better tolerated (P=0.034).

CLP-2

Observational comparative effectiveness study of s-adenosyl methionine and etoricoxib in cases of knee osteoarthritis.

Prashant S. Chaudhary , S.K. Saraf 1 , Alok Singh, S.P. Mishra, B.L. Pandey

Departments of Pharmacology, 1 Orthopedics, Institute of Medical Sciences, Banaras Hindu University, Varanasi - 221 005, Uttar Pradesh, India.

Objective
: Osteoarthritis affects almost half the population above the age of 45 years. Therapy is largely symptomatic with NSAIDs which pose risk in the elderly. Supplement cartilage ingredients are sometimes employed with no consensus. S-Adenosyl Methionine is significant natural body constituent with novel property of blunting inflammatory process and cartilage degradation. Genomic disorder in homocysteine profile combines many ageing diseases with obesity. Strong correlation of osteoarthritis with ageing and obesity imparted greater therapeutic rational to examine the effect of S-Adenosyl Methionine in osteoarthritis. Present observational study in 85 cases attempts to examine therapeutic outcome with S-Adenosyl Methionine disease modifying therapy in comparison with standard etoricoxib therapy in cases of knee osteoarthritis. Materials and Methods : 400mg daily dose of SAMe for 3 months was studied for clinical benefit on KOOS score measures in 44 cases with radiological grade II and III osteoarthritis. 41 cases treated with etoricoxib 60 mg BD were the group for comparison. Result : S-Adenosyl Methionine therapy markedly benefited in overall improvement of KOOS score highly significantly as also the activities of daily living scores as well as recreational activities. Quality of life also significantly improved. SAMe indeed has been reported to have specific anti-arthritic effects and promotive to general well-being. Conclusion : The study both confirms SAMe as superior therapeutic option and supports possibility of homocysteinaemic disorder in osteoarthritis awaiting elaboration.

CLP-3

Riluzole in irritable bowel syndrome and functional dyspepsia: Efficacy and comparative effectiveness study with conventional pharmacotherapies

Suryaprakash Mishra , S.K. Shukla 1 , B.L. Pandey

Departments of Pharmacology, and 1 Gastroenterology, Institute of Medical Sciences, Banaras Hindu University, Varanasi - 221 005, Uttar Pradesh, India

Objective: Visceral hypersensitivity is key dysfunction behind symptoms of IBS, traditionally addressed with anxiolytics, antispasmodics etc. New understanding on mechanisms of the disease has opened scope for drug acting on neurotransmitter transporter as rational therapeutic agents to control visceral hypersensitivity in functional bowel disorders. Riluzole facilitates glutamate removal from synapses and also is NMDA receptor antagonist, hence its therapeutic promise is assessed . Materials and Methods: Patients were included after elimination of any other confounding comorbidities. Other covariates of age,sex,BMI,disease duration etc were included as such. Diagnosed cases of IBS and functional dyspepsia are given Riluzole 50 mg BD as "add on" to standard therapy of antispasmodic,antacid,probiotic regimen and compared to standard treatment alone or standard treatment with antidepressants/anxiolytics. Pretreatment and 2 weeks follow up scoring of symptoms in patients is done based on Gastrointestinal Symptom Rating Scale(GSRS) to measure the relief conferred by the regimens. Result: Study is currently ongoing and present preliminary observations relate only to 32 studied cases. Riluzole add on therapy group gave significantly superior relief in scores of visceral pain, nausea-vomiting, and symptoms of gastrointestinal motility compared to the standard group and standard with anxiolytics therapy group. Conclusion: Riluzole representing novel therapeutic mechanism of treating IBS and functional dyspepsia is substantiated to be relevant and promising. Wider evaluations may help to establish present findings thereby reducing present costs for optimal use of this new therapeutic option in major malady of IBS and functional dyspepsia.

CLP-4

Trends in prescribing antimicrobials in post operative wards in a tertiary care hospital.

Prashanth P., Narendranath S., Geetha M., Naveen M., Reshma S.R.

Department of Pharmacology, JJM Medical College, Davangere-577004, India

Objectives: To analyse utilisation of antimicrobials in post-operative wards of a tertiary care hospital. Materials and Methods: A descriptive prospective study was conducted in the post-operative wards of Obstetrics and gynaecology (OBG), surgery and orthopaedic units of Bapuji hospital during the months between April and July 2011. Prescriptions of all patients were collected, relevant information entered in a preformed proforma and analysed. Results: A total of 255 prescriptions were analysed of which 108 belonged to obstetrics, 110 to surgery and 37 to orthopaedics units respectively.Among the OBG cases, 105 patients (97.2%) received cephalosporins alone or in combination with other antimicrobials. In this group, most commonly prescribed was ceftriaxone (50.4%), followed by cefotaxime (27.6%), followed by ceftriaxone-sulbactum (10.47%). Tinidazole was the most commonly prescribed drug after cephalosporins (24%). Among the surgery cases, 106 patients (96.36%) received cephalosporins. In this group, most commonly prescribed was cefotaxime (38.6%), followed by ceftriaxone (32.72%), followed by cefuroxime (24.54%). Metronidazole being most commonly prescribed drug after cephalosporins (30%). Among the orthopaedic cases, 30 patients (81.08%) received cephalosporins. In this group, most commonly prescribed was ceftriaxone-sulbactum (46.66%) combination, followed by ceftriaxone (20%), followed by cefotaxime-sulbactum (13.33%). Amikacin being most commonly prescribed drug after cephalosporins (43.24%). Conclusion: Cephalosporins are the preferred antimicrobials for surgical prophylaxis for aerobic bacteria and are prescribed in over 90% of cases either alone or concurrently with other antimicrobials. Use of other antimicrobials was limited to 35.5%, of which amikacin constituted 10.98% and piperacillin- tazobactum constituted 10.58%. Ampicillin being least common (0.78%). Among the anaerobic antimicrobials, most commonly prescribed was metronidazole (19.21%), tinidazole (10.19%), followed by ornidazole (6.66%).

CLP-5

Trends in prescribing antimicrobials in an ENT outpatient department of a tertiary care hospital for upper respiratory tract infections

Ramachandra K. , Narendranath S., H. S. Somashekar, Abhishek Acharya, Keerthi Sagar J., Susheela S. Halemani

Department of Pharmacology, JJM Medical College, Davanagere - 577004, India.

Objectives:
Antimicrobials utilization in the Out patient department of ENT will be analysed using the Drug utilization 90% [(DU-90%)]. Materials and Methods: A Prospective study was conducted in the out patient department of ENT at Bapuji hospital during May to July months of 2011. Prescriptions of all patients were collected, relevant information entered in a preformed proforma and analysed. Results: A total 300 prescriptions were analysed. The common cases for which antimicrobials prescribed were infections like pharyngitis, acute suppurative otitis media(ASOM), chronic suppurative otitis media (CSOM), tonsillitis, laryngitis. Out of which 142 patients (47.33%) received amoxycillin alone, 52 patients (17.33%) received combination of amoxycillin and clavulinic acid, 43 patients (14.33%) received cefixime, 40 patients (13.33%) received cefuroxime, 23 patients(7.66%) received azithromycin, levofloxacin and other antimicrobials. Among these, most commonly prescribed was amoxycillin followed by combination of amoxycillin and clavulinic acid. Conclusion: The present study shows that among the various antimicrobials used,only four antimicrobials figured in DU-90% segment which were amoxycillin, combination of amoxycillin and clavulinic acid and cephalosporins.Though azithromycin and levofloxacin are also most commonly used drugs in upper respiratory tract infection, but does not come under DU-90% segment.

CLP-6

Knowledge, attitude and practices of post graduate students regarding pharmacovigilance in a tertiary care hospital in Mangalore

Ashwini Mandanna M. , Roopa P. Nayak, Mohandas Rai, Sharath Kumar K., Sudha M. J.

Department of Pharmacology, A. J. Institute of Medical Sciences, Mangalore - 575004, India

Background and Objectives:
The WHO defines pharmacovigilance as the pharmacological science and activities relating to detection, assessment, understanding and prevention of adverse drug reactions or any other drug related problems. Drug related adverse effects cause considerable burden to health care systems around the world. Reporting of adverse drug reaction is the basis of efficient pharmacovigilance. This in turn depends on the views and practices of the health care givers. Assessing the knowledge, attitude and practices thus becomes important for improving the reporting of adverse drug reaction.The objective of this study is to evaluate the current knowledge, attitude and practices of the post graduates regarding pharmacovigilance in a tertiary care hospital. Materials and Methods: Postgraduates from various specialities are requested to answer a preformed structured questionnaire to assess their knowledge, attitude and practices regarding Adverse Drug Reaction Reporting. Completed questionnaire will be collected, compiled and data will be analysed. Conclusions: This study will be useful for increasing the knowledge of adverse drug reaction reporting and achieve more efficient pharmacovigilance.

CLP-7

Fixed drug eruptions - a study in tertiary care hospital


Sarala N., Harish S. , Bhuvana K., Rajendra O. 1

Departments of Pharmacology, and 1 Dermatology, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka, India.

Objective: To study the occurrence of Fixed Drug Eruptions (FDE s) to different drugs. Materials and Methods : This study was conducted by department of Pharmacology, Sri Devaraj Urs Medical College, Kolar from January 2009 to December 2010. During this period the details of patients manifesting with FDE and drugs causing them were collected from both in and out patients. The data was analyzed for age, gender, site of reaction, drugs implicated and their outcome. Results: A total of 94 adverse drug reactions were collected of which 18 were diagnosed as FDE. Among them 10 were males and 8 females aged between 2- 60 years. 13 FDEs were due to NSAIDs(diclofenac, nimesulide, paracetamol, piroxicam) and 5 due to antimicrobials (ciprofloxacin, norfloxacin) . The site of lesion in all cases was over the extremities, and 10 cases also had it over the lips and 2 cases on genital and oral mucous membrane respectively. Dechallenge was done and therapeutic rechallenge was observed in all the cases. Conclusion: Literature shows around 16-21% of FDEs and in our study we have observed 19.1%, of which 72.3 % were due to NSAIDs and 27.7 % were due to antimicrobials. All of them recovered. Over the counter availability of NSAIDs could be the probable reason for higher occurrence.

CLP-8

Adverse drug reactions encountered during antiretroviral therapy

Balamurali K. , Sarala N., Kumar T.N.

Department of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka, India.

Objective: To study the pattern of adverse drug reactions (ADRs) to anti- retroviral drugs. Materials and Methods: This study was conducted by the Department of Pharmacology, Sri DevarajUrs Medical College, Kolar. The study duration was 11 months. All the suspected drug reactions were collected. The data was then analysed for age, gender, type of reaction, drugs implicated and outcome. Results: There were 124 adverse drug reactions of which 49 were due to antiretroviral therapy. Male to female ratio was 30:19 with a mean age of 36.3±11.7 and 33.7 ± 8.19 years respectively. Among 49 patients, 24 received Zidovudine (300mgBD) with Lamivudine (150mgBD) and Nevirapine (200mgBD)(Z+L+N), 23 received Stavudine (30mgBD) with Lamivudine (150mgBD) and Nevirapine (200mgBD)(S+L+N) and 2 were on combination of Efavirenz (200mgBD) with Stavudine (30mgBD) and Lamivudine (150mgBD)(E+L+S). 18 had gastritis and diarrhoea within 14 days of treatment with Z+L+N and S+L+N. 7 developed anaemia after 5 months of therapy with Z+L+N and, 5 had elevated hepatic enzymes after 1year with S+L+N regimen. Hepatic enzymes elevation and rashes were common in females, anaemia and polyneuritis in males. 10 out of 49 had immune reconstitution syndrome,6 rashes and 3 polyneuritis. Conclusion: We observed HIV infections in third decade of life. Gastrointestinal adverse effects and rashes were tolerable. Careful monitoring of ADRs, early detection and intervention wherever possible, will improve their quality of life.

CLP-9

Antibiotic prescription pattern in the paediatric in-patients department

Choudhury D.K. , Bezbaruah B.K.

Department of Pharmacology, Gauahti Medical College, Guwahati, Assam - 781 032, India

Objectives : 1) To study the antibiotic prescription pattern in Paediatric in-patients department in Gauhati Medical College and Hospital, Guwahati, Assam. 2) To analyse the rationale of antibiotic use. Materials and Methods: This study was conducted in pediatrics department of Gauahti Medical College and hospital from 18 th April to 17 th May 2011. The details of the patients were being recorded in a specific format and results were analyzed by descriptive studies and expressed as mean and standard deviation. Results : Among 200 patients included in the study, 120 were males and 80 were females. The number of drugs per prescription was 3.60 ± 2.04 and number of antibiotics per prescription was 1.41 ± 0.67. The duration of antibiotic therapy was 6.04 ± 3.44 days. 66% patients were prescribed antibiotic(s), 33% patients without antibiotic prescriptions and 04% patients were kept only in observation. Out of 132 antibiotic prescribing patients, 71% were getting single antibiotic. Maximum antibiotic prescriptions were found in the age group of 5-12 years. 95% of patients were getting parenteral preparation. Cephalosporin (41.5%) was the common antibiotic group. Amoxicillin and clavulanic acid, cefotaxime and sulbactum were found to be common combinations. Conclusions: Our study suggests that strategies to control antibiotic use should focus on patient's population especially in children and infants. The antibiotic treatment was done in accordance with WHO guidelines. Proper drug utilization is being found to be critically evaluated and results analysed accordingly.

CLP-10

A study of the pattern of antibiotic use in non tubercular acute bacterial meningitis in pediatric patient in a tertiary care hospital

D. Chatterjee , T. Achamma 1 , K.V. Ramesh, Deepa. S.

Department of Pharmacology, International Medical School, Bangalore, 1 Department of Pediatrics, Bangalore Baptist Hospital, Banglore, India.

Objectives: To study the pattern of antibiotic use for pediatric non tubercular acute bacterial meningitis in a tertiary care hospital. Materials and Methods: Fifty eight pediatric meningitis prescriptions from the source document of Bangalore Baptist hospital were evaluated. Eleven prescriptions have met the study criteria. Data has been generated on gender and age of the patient, average day of hospital stay, total number of drugs used. Number of drugs prescribed per prescription was accounted. Frequency of administration of different types of antibiotic and non antibiotics was recorded. Routes of administration employed have also been documented. Data analysis was done by using Microsoft Excel. Results are expressed in percentages and Mean-standard deviation (SD). Results: Mean age of pediatric patient was 3.41±3, Male patients were 36 percent and female patients were 64 percent. The average length of hospital stay was 13.27±3.1. Average number of drugs, antibiotics and non antibiotic drugs prescribed per prescription was 4.54±1.69, 2.64±1.2, 2±1.09. Ceftriaxone was the main antibiotic used for all patients. Further, chloramphenicol and vancomycin, gentamicin, penicillin-G, amikacin, meropenem have been used. Acyclovir was used in twenty seven percent patients. Other supporting drugs phenytoin-67%, was most frequently used followed by dexamethasone and mannitol-18%. Most of the antibiotics were administered intra- venously. Conclusions: Combination of antibiotic therapy was effective and the success rate is cent percent. Duration of hospital stay is comparatively similar. Chemotherapeutic and other supporting drug regimens stand on scientific merits though the selection of antibiotic is aggressive on empirical basis.

CLP-11

A prospective study of cutaneous adverse drug reactions in a tertiary care hospital


R. Nandini, A.C. Yegneshwaran, Keerthika B.

Institute of Pharmacology, Madras Medical College, Chennai - 03, India.

Objectives:
To evaluate the incidence of Cutaneous Adverse Drug Reactions (CADRs) in a tertiary care hospital, its associated health impact and to establish a causal link between the drug and reaction. Materials and Methods: A Prospective, observational study was conducted over a period of 10 months (nov 2010 toaug, 2011) in patients presenting with cutaneous manifestations after drug intake, attending Department of Dermatology, Rajiv Gandhi Govt General Hospital. Causality assessment of ADR was done according to WHO scale and data analysed statistically. Results: 160 CADRs were recorded.Among them,83 (52%)were males and 77(48%) females. The age group 21-40 yrs showed the maximum number of cases (n=61,38.13%). The drugs commonly responsible were anti-bacterials (41%) followed by NSAIDS(12%) and Anti-Epileptics(12%). Over the Counter drugs accounted for 19.38%.The presentation of CADRs wereas follows: maculopapular rash -23.75% (n=38), urticaria-21.88%( n=35), Toxic Epidermal Necrolysis4.3%(n=7).The time lag between drug intake and onset of reaction was between 1 and 5 days in 40.6%.WHO scale showed 2% as certain; 74% probable and 24% possible.35.6% (n=57) requiredhospital admissions of which 3.13% required Intensive Care. CADRs outcome showed improvementin 97% (n=156) and 3%(n=4) expired. Conclusion: Cutaneous reactions are the common manifestations of ADRs. Causality link between drug and the reaction was established. 35.6% required hospita admissions

CLP-12

Comparative, randomized, open label, parallel, multicentric study of safety and efficacy of oral balofloxacin versus levofloxacin in patients with uncomplicated urinary tract infections

J.C. Shobha* , C. Srinivas, P. Mohan Rao, Charles S. Manian, Jayanth K. Panda, B. Mohan Reddy

Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Punjagutta, Hyderabad, Andhra Pradesh, India.

Objective: To evaluate the clinical safety and efficacy of oral Balofloxacin as compared to Levofloxacin in the treatment of uncomplicated urinary tract infections (UTI). Materials and Methods: After fulfilling the inclusion and exclusion criteria patients were enrolled in eleven centers after written informed consent was obtained. This study was approved by the institutional ethics committee of each center. Patients' clinical assessment for fever, haematuria, burning micturition, dysuria, supra pubic pain, frequency of micturition and urgency and microbiological assessment for growth of pathogen were recorded at baseline, on day 4 and the end of the study 7/10 day. Investigations were done at baseline and end of the study. Safety evaluation like recording of side effects was done at each follow up visit. Balofloxacin in the dose of 100mg was given twice daily and levofloxacin 500mg was given once daily for 7/10 days. Global evaluation by the patient and as well as the investigator was done at the end of the study. Statistical analysis of the data was done by using ANOVA and wilcoxon signed rank test. Results: Two hundred and twenty seven patients were enrolled in the study at 11 centres. At baseline, both the treatment groups were comparable. In the Balofloxacin group (n = 113) and Levofloxacin group (114) patients were enrolled. As compared to baseline there was statistically significant improvement in various signs and symptoms of uncomplicated UTI like burning micturition, dysuria, suprapubic pain, frequency of micturition and urgency in both the treatment groups of Balofloxacin and Levofloxacin (P< 0.05). Between the groups there was no statistically significant difference in any of the signs and symptoms ( ns). Clinical response in Balofloxacin group - 77% showed clinical cure and 23 % clinical improvement. In Levofloxacin group-72% showed clinical cure, 27% clinical improvement and 1% clinical failure. Microbiological response the eradication and persistence of the pathogen was 91% and 9% in the Balofloxacin and 80% and 20 % in Levofloxacin group respectively. Patient's and investigator's global evaluation was in favourof Balofloxacin. None of the patients were withdrawn from the study due to adverse effects. Both the study medications were well tolerated by all the patients without any serious side effects. Conclusions: Balofloxacin is safe and effective in the dose of 100mg bid as an alternative treatment in the management of uncomplicated urinary tract infections.

CLP-13

Evaluation of safety and efficacy of Curcuma longa linn.Standardized extract [NR-INF-02], glucosamine sulphate and combination of two in the treatment of painful knee osteoarthritis: A randomized, placebo controlled trial


Madhu K., Lohit K. , Saji M.J., Chanda Kulkarni

Department of Pharmacology, St. John's Medical College, Koramangala, Bengaluru, India.

Objectives: 1. To evaluate safety and efficacy of NR-INF-02 and Glucosamine sulphate alone in treatment of painful osteoarthritis(OA). 2. To compare the same with placebo and combination of the two in painful knee OA. Materials and Methods: A single blind, randomized, placebo controlled trial registered under CTRI was carried out after obtaining IERB approval; in 120/157 patients with diagnosis of painful knee OA based on the eligibility criteria. Patients were randomized into four arms with 30 each to receive- placebo 500mg, NR-INF-02 (Curcuma longa linn.-standardized extract) and GS 375mg/500mg capsule each and combination of GS with NR-INF-02. The duration of treatment was 42 days with follow-up on 21 st and 42 nd day. At the end of treatment period primary efficacy outcome was measured using, WOMAC, Visual Analogue Scale[VAS], Clinician Global Impression of Change[CGIC] and by clinical-examination. Secondary efficacy outcome was measured by recording number of rescue medications used. Patients were monitored for ADRs at each visit. Analysis done using, chi-square test, repeated measures ANOVA, mixed model analysis and presented as inferential statistics using SPSS-ver.16.0. Results: NR-INF-02 treated patients showed a significant decrease in OA symptoms (WOMAC:P<0.05, VAS:P<0.05, CGIC:P<0.001) and used lesser number of rescue medications(P<0.05) along with greater clinical and subjective improvement compared to placebo group. The overall improvement in clinical features was more in patients treated with GS alone and combination of GS with NR-INF-02, and this was statistically not significant. Further, patients on NR-INF-02 exhibited good safety profile with minimal ADRs. Conclusion: The study demonstrated acceptable tolerability and efficacy of NR-INF02 in doses used on various algofunctional indices. Therefore the herbal extract NR-INF-02 may be considered as one of the treatment options in patients with uncomplicated knee OA.

CLP-14

Characteristics, determinants and cost implications of severe adverse drug reactions in ccu0 of a tertiary care hospital

Naveen A. , Kamath D., Padmini D., Sushma S., Sandra S., Sumithra S.

Department of Pharmacology, St. John's Medical College, Koramangala, Bangalore, India.

Objective: To assess the frequency, characteristics and incremental cost of severe ADRs in coronary care unit (CCU) of a tertiary care Hospital. Materials and Methods: Two trained physicians retrospectively reviewed case records of all in-patients admitted to CCU over one year (Jan -Dec 2008) and identified ADRs. Each ADR was assessed for causality (Naranjo's algorithm), severity (modified Hartwig and Siegel scale), predictability and preventability (modified Schumock and Thornton scale). Inter reviewer agreements were assessed using Cohen's Kappa. Determinants for developing severe ADRs were identified using multiple binary logistic regression. Cost of ADR management was estimated based on the corrected duration of excess hospital stay after adjusting for age, gender, co-morbid conditions and number of drugs. Results: Of 595 admissions, 152 (25.5%) patients experienced 196 ADRs. 56 (28.5%) ADRs were severe. Patients with severe ADR had longer duration of CCU stay (0.8 extra day) and hospital stay (2.8 extra days) (p <0.05). 89.3% were predictable and 46.4% probably preventable. Streptokinase was the most common drug associated with severe ADRs. Arrhythmias were the most common ADRs. Presence of renal dysfunction (OR 1.66, CI 1.007 - 2.72), arrhythmias (OR 1.74, CI 1.052 - 2.87) and polypharmacy (>10 drugs) (OR 11.3, CI 1.45 - 87.44) were the predictors for occurrence of severe ADRs. The mean incremental cost incurred by the severe ADRs per patient was Rupee 2170 per additional day of hospital stay. Conclusion: Higher incidence of severe ADRs in CCU add considerably to treatment costs. Renal dysfunction, cardiac arrhythmias and poly pharmacy are important predictors of severe ADRs.

CLP-15

Pharmacovigilance of antiepileptic drugs in pediatric patients receiving antiepileptic drug therapy in rural population visiting tertiary care hospital: A mid term review

Akanksha Suman , Devesh D. Gosavi, Manish Jain

Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India.

Objective : To analyze the ADR profile of antiepileptic drug therapy in pediatric age group in tertiary care hospital serving rural population. Materials and Methods: Children both indoor and outdoor on antiepileptic drug therapy were included. They were assessed for different demographic and clinical parameters for 8 months duration. History was taken with help of questionnaire. Causality analysis was done with Naranjo's scale. Therapeutic Drug Monitoring was done. Results: Total 72 patients were included, 44(61.1%males), 28(38.8%females). Commonly prescribed drugs were Sodium valproate, Phenytoin, Phenobarbitone and Carbamazepine. Incidence of ADR was high i.e 34% (25 out of 72 patients). Out of 25 patients, Sodium Valproate(8), Phenytoin(6), Phenobarbitone(5), Carbamazepine(2), Diazepam(3) and Lorazepam(1). Total ADR observed were 46 as one drug causes more than one ADR.. Naranjo's algorithm showed 34(73.95) ADRs as probable and 12(26%) ADRs of possible category. All body systems were involved, with CNS(15), GIT(10), cognitive(7), skin(4), eye(3), hematological(2) and others(5). New possible ADRs observed were Phenytoin induced swelling all over body and Sodium valproate induced neutrophilic leucocytosis.TDM results correlate with toxic ADRs of drugs. Conclusion : Sodium valproate appears to be most toxic of all. The high incidence of ADR can be due to small samplesizeand this being the Rural tertiary care hospital. Although sedation was a common ADR which disappeared later due to tolerance. The role of patient education, TDM and Surveillance is more emphasize with this kind of results. The full sample size will bring out the real picture.

CLP-16

A randomized, controlled, phase 4 trial comparing efficacy and safety of olopatadine and levocetrizine in chronic urticaria

Amrita Sil , Santanu Kumar Tripathi, Anita Choudhuri 1 , Nilay Kanti Das 2 , Avijit Hazra 3 , Chiranjib Bagchi, Chowdhury Nazrul Islam

Department of Pharmacology, Burdwan Medical College, Burdwan, West Bengal, 1 Department of Dermatology, Leprology and Venereology, Medical College, Kolkata, 2 Department of Pharmacology, IPGMER, Kolkata, India.

Objectives:
Chronic urticaria (CU) is characterised by daily appearance of wheals for ≥ 6 weeks. Second-generation antihistamines are considered first line therapy for CU. Olopatadine, a newer antihistamine with additional anti-inflammatory properties, is a new second generation antihistamine in India. The present study was undertaken to compare efficacy and safety of olopatadine with standard second-generation antihistamine, levocetrizine in CU treatment. Materials and Methods: This single-centre, assessor-blind, randomised, active-controlled, parallel-design, phase 4 trial (CTRI/2011/08/001965) was conducted at the outpatients'-department (OPD) of a rural teaching hospital in West Bengal. A total of 120 adult patients of either sex suffering from CU, randomised equally into two groups, received either olopatadine (5 mg) BD or levocetrizine tablets (5 mg) OD orally for a period of 9 weeks. Primary efficacy outcome was Urticaria Total Severity Score (TSS). Secondary outcome measures were Physicians' and Patients' global assessment of disease activity improvement and improvement in quality of life (DLQI® score). Safety measures were haematological and biochemical tests and treatment-emergent adverse events. Results: A total of 105 subjects who completed the total duration of treatment (54 in olopatadine-group and 51 in levocetrizine-group) were analysed. The TSS scores in both groups declined significantly (p<0.001) over the treatment period and decline was significantly more in olopatadine (baseline 15.24 ± 3.88, EOT visit 4.83 ± 4.73) than levocetrizine (baseline 14.63 ± 1.48 EOT visit 8.18 ± 3.85). Secondary outcome measures also significantly improved (p <0.05) with both drugs. Sedation, anti-cholinergic adverse effects were comparable in both arms. Two patients receiving levocetrizine suffered from possible drug-induced hepatotoxicity. Compliance was excellent in both the treatment arms. Conclusion: Olopatadine is safe and efficacious alternative to levocetrizine in treatment of CU.

CLP-17

Comparison of drug sparing effect of two Alpha2 agonists as preanaesthetic and intraoperative agent

Priyanka Singh , A.P. Pawar, Bijoy Kr. Panda, Sourabh Marne, Sarita Swami 1 , Varshali Keniya 1

Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, 1 Department of Anesthesiology, Bharati Hospital and Research Centre, Pune, Maharashtra, India.

Objective: To assess and compare the requirement of preanaesthetic agents to maintain anesthesia within the group of control and groups receiving Clonidine and Dexmedetomidine. Materials and Methods: Three groups of control, clonidine and dexmedetomidine were made. Twenty patients of American Society of Anesthesiologist's grade I and II category for ≥3 hours of surgery and >18 years of age were involved in the study of six months duration in each group. Hemodynamic variables of all patients were continuously recorded and maintained. Then, during surgery with anesthesiologists we have quantified the amount of drugs spared by use of these alpha 2 agonists. Result: Dexmedetomidine and Clonidine were found hemodynamically stable during intubation compared to Control. Dexmedetomidine group showed 25% reduction in Isoflurane and 40% reduction in Diclofenac requirement compared to Clonidine group. The average Fentanyl dose was reduced by 33% and 44% in Clonidine and Dexmedetomidine group respectively compared to Control group. Diclofenac and propofol requirement was found to be less in dexmedetomidine group than of clonidine. Conclusion: Intraoperatively dexmedetomidine showed significant cardiovascular stability compared to clonidine. Also, Dexmedetomidine group showed significant drug sparing effect of Isoflurane, Thiopentone and Fentanyl than Control group but no significant difference was observed when compared with Clonidine group. A clinical pharmacist can assist anesthesiologist's in apt selection of drugs.

CLP-18

Myelotoxicity of thienopyridines

Swarna Maseneni , Karin Brecht, Stephan Krähenbühl

Clinical Pharmacology and Toxicology, Department of Biomedicine, University Hospital Basel, Basel, Switzerland

Introduction : Clopidogrel and ticlopidine are thienopyridine pro-drugs that need activation by cytochrome P450 (CYP) to exert their anti-platelet effect. One of the most important toxic effects is myelotoxicity. The active metabolites formed in intestine and liver may be too reactive and may therefore reach only a low concentration in the myelon, suggesting that there may be activation of thienopyridines in the myelon. The aim was to assess myelotoxicity of thienopyridines with different assays in different cell systems and to find out responsible mechanisms. Methods and Results: We showed the contribution of CYP3A4 and myeloperoxidase to the toxicity of clopidogrel (10μM and 100μM) and ticlopidine (10μM and 100μM) in vitro. We treated HL-60 cells, CYP3A4 over expressing HL-60 cells (3A4 cells), HL-60 cells co-incubated with myeloperoxidase to investigate toxicity mechanisms. We assayed for signs of cytotoxicity, apoptosis, mitochondrial dysfunction, reactive oxygen species, and metabolism of the drugs. The experiments showed a significant increase of toxicity in 3A4 cells when compared to HL-60 cells, supporting the hypothesis that mercapto group is toxic. The inhibitory experiments with ketoconazole rescued the cells, confirming the role of CYP3A4 in toxicity. The HL-60 cells co-incubated with myeloperoxidase showed an enhanced toxicity. Our results suggest that two independent metabolic pathways are involved in the toxicity of thienopyridines.

CLP-19

Effect of obesity and overweight on fasting blood sugar, insulin, serum lipids and blood pressure in Indian school going children

Patel V.D. , Goyal R.K., Patel S.S. 1

Sterling Hospital and Department of Pharmacology, L. M. College of Pharmacy, Ahmedabad - 380 009, 1 Department of Pharmacology, Institute of Pharmacy, Nirma University, Ahmedabad - 382 481, Gujarat, India.

Objective: To examine the association of hyperinsulinemia with the atherogenic risk profile in Indian adolescent school going children in the age group of 12-18 years. Materials and Methods: Obese and overweight children were ascertained in a representative crosssectional study of 5664 school children. We studied effect of obesity and overweight on fasting plasma insulin level with indices of obesity body mass index, glucose,serum cholesterol, triglyceride, lipoprotein levels, and blood pressure in a case-controlstudy of 50 children matched by normal controls. Results: Fasting insulin levels serum triglyceride, cholesterol, low-density lipoproteinand very-low-density lipoprotein cholesterol cholesterol levels, high-densitylipoprotein cholesterol levels are significantly (P<0.05) different from normal control,whereas there were slight changes in glucose levels were observed in obese andoverweight children as compared to normal control.. Systolic and diastolic bloodpressures were significantly different in boys and girls in obese and overweight children as compared to normal control. Conclusion: We conclude that the fasting plasma insulin level may be used as amarker for the development of obesity-associated metabolic disorders and elevated blood pressure in children.


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CVS-1

A prospective observational study to evaluate the pattern of potential drug interactions in an intensive cardiac care and cardiac ward set up of a tertiary care hospital

Joshi P. B. , Kadhe N. G., Pawar S. R.

9, Aryavarta, Deshmukh Wadi, Mithagar Road, Mulund East, Mumbai - 400 081, India.

Objectives: To evaluate the pattern of potential drug-drug interaction (pDDIs) in an intensive cardiac care and ward set up of a tertiary care hospital with respect to the following criteria: 1. The severity of pDDIs. 2. The type of a pDDIs. 3. The time of onset of a pDDIs. 4. The level of scientific evidence for documented pDDIs. 5. The level of clinical significance rating of a pDDIs. Materials and Methods: All patients admitted to the intensive cardiac care unit and ward set up and fulfilling the recruitment criteria were studied for their prescription. Recruitment criteria included admission to Intensive cardiac care and ward set up for a minimum of 24 hrs, more than 18 years of age, of either gender, with prescription of a minimum of three drugs. Certain elements of prescription like herbal preparations, topical drugs, pharmaceutical incompatibilities, drug-alcohol interactions and any self medication by the patient were not included in study. The prescriptions were evaluated for potential drug-drug interactions with respect to their severity, onset, level of scientific evidence for documented reactions, and level of clinical significance rating by a software database, Drug Interaction Facts, 2009, Drug interaction Checker from Healthline.com and Medscape.com. Results : Of the 100 prescriptions analyzed, there were 834 pDDIs found in 912 prescribed drugs. On the severity scale, there were 19.78% Major, 48.92% Moderate, 31.29% Minor pDDIs. The Onset of action was rapid in 30.45% and delayed in 69.54%. The mechanism of action was Pharmacokinetic in 39.44%, Pharmacodynamic in 44% and Unknown in 16.54%. The level of scientific evidence amounts to 0.35% Established, 19.30% Probable, 36.33% Suspected, 24.94% Possible and 19.06% Unlikely. The clinical significance rating is 1(9.35%), 2(36%), 3(9.83%), 4(14.7%) and 5(30.1%). Conclusion : It was evident that there were many potential drug-drug interactions in an intensive cardiac care set up. These interactions can give rise to serious adverse events if proper monitoring is not done. As a result, interacting drug combinations of major severity should be vigilantly avoided. This study gives an overview of the pattern of potential drug-drug interactions in this set up. An extended study to find out the incidence of adverse events in interacting drug pairs may be carried out to throw more light on this issue.

CVS-2

Is root extract of tinospora cordifolia more effective than statins with regard to liver toxicity? A preliminary study in hyperlipidemic model in rats

Sparsha Deep E.M. , Roopa Nayak P., Mohandas Rai

Department of Pharmacology, AJIMS, Mangalore - 575004, India.

Objectives: To elucidate the possible role of aqueous root extract of Tinospora cordifolia in prevention of hepatotoxicity as compared to statins in diet induced hyperlipidemia in rats. Materials and Methods: Total duration of study was 2 months. Hyperlipidemia was induced in rats by feeding them with high fat diet for 30 days. Rosuvastatin (10mg/kg, per oral) was the standard drug used. Test extract (2.5 and 5g/kg, per oral) and standard drug were given for next 30 days. Serum liver enzymes (SGOT/SGPT) levels were observed in the treatment period. Results: There was significant elevation (P<0.0001) in the serum liver enzyme levels in hyperlipidemic control group. Serum liver enzyme levels showed significant reduction (P<0.0001) in the test group but no significant reduction (P=0.056) was observed in standard group. Conclusion: This study suggests a promising protective role of aqueous root extract of Tinospora cordifolia in prevention of hepatotoxicity compared to statins. Further studies are necessary in this line to confirm this role.

CVS-3

Study of the antihyperlipidemic, antiatherogenic and antioxidative activity of cassia fistulain rabbit receiving high fat diet

Hakim A. , Das S.

Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh, Assam-786 002, India

Objective : To study the effect of Cassia fistula on Serum lipid profile, Atherogenesis and Oxidative stress in rabbit receiving high fat diet. Materials and Methods: Twenty numbers of rabbit of either sex were taken and divided into four groups, 5 rabbit in each and treated as follows- Normal Control- received normal diet, Experimental Control- received high fat diet, Test drug - received high fat diet plus ethanolic extract of Cassia fistula (EECF) at a dose of 500 mg/Kg BW/ day orally and Standard Drug- received high fat diet plus Atorvastatin at a dose of 2.1 mg/Kg BW/day orally. The experiment carried out for 12 weeks and then blood sample collected from marginal ear vein and lipid profile (Total cholesterol, Triglyceride, HDL, LDL) was estimated. Catalase and Malondialdehyde (MDA) levels were measured for antioxidant status. The antiatherogenic effect was measured by atherogenic Index and histopathology of aorta. Results : All results were statistically analysed by one way ANOVA followed by multiple Dunnett's test. P value < 0.05 considered as significant. EECF significantly decreased serum lipids towards normal levels (P<0.05). It also increases catalase activity and decreases MDA activity as anti-oxidant action (P<0.05) and on histopathological examination reduced atherogenic plaques in size and number in aorta (P<0.05). Conclusion : Results show that EECF has hypolipidemic, anti-oxidant and anti-atherogenic effects in rabbits receiving high fat diet.

CVS-4

To compare the effect of combination of Tramadol and Paracetamol with NSAID's on blood pressure in patients of hypertension with osteoarthritis


H.S. Somashekar, Swamy Hiremath, Raghu Prasada M.S. , Shankar A.S., Veena

Department of Pharmacology, JJ Medical College, Davanagere

Objective: An observational study on the effects of combination of tramadol and paracetamol in comparison to NSAIDS on the blood pressure of the patients with osteoarthritis and hypertension. Materials and Methods: The clinical study was conducted in JJM Medial college and Chigateri government hospital Davanagere, Karnataka. The patients with osteoarthritis and hypertension were divided into two groups consisting of 30 patients in each group .One group is given NSAIDS and other group is given Tramadol+paracetamol combination. The blood pressure of patients were recorded before and after experiment. Mann-whitney test and Wilcoxon signed rank test was also used for statistical analysis. Results: Compared to the NSAID group ,the Tramadol+paracetamol group showed significant decrease in systolic blood pressure and diastolic blood pressure. Conclusion: Results of study suggests that tramadol +paracetamol group patients were having significant decrease in blood pressure compared to NSAID group probably because of no salt and water retention property in tramadol group but not due to any antihypertensive action of these drug.

CVS-5

A comparative evaluation of the percentage of patients with dyslipidemia who reach LDL-C goals with different starting doses of Atorvastatin - A randomised prospective study

Ghia Canna J. , Khobragade Linesh R., Jha Rajesh K.

Department of Pharmacology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha 442 004, Maharashtra. India.

Objective: 1) To compare the percentage of patients who reach LDL-C goals with 10 mg vs. 20 mg of atorvastatin as starting dose. 2) To compare the incidence of adverse events in patients on 10 mg vs. 20 mg of atorvastatin. Materials and Methods: The study was carried out in Acharya Vinoba Bhave rural hospital, Wardha, Maharashtra from November 2010 to May 2011.It was a prospective, randomized, double blind, parallel groups, unicentre study. 150 patients with dyslipidemia,were randomized into two groups of 75 each. Group 1 received Atorvastatin 10 mg once daily and Group II received Atorvastatin 20 mg once daily for 3 months. Safety reporting was done by monitoring the incidence of adverse effects. Results: Atorvastatin reduced LDL-C levels by 23.43% to 31.14% at 4 weeks and 37.80% and 45.51% at 12 weeks across the dose range of 10 mg and 20 mg respectively. Reduction in LDL- cholesterol and total cholesterol was significantly greater in the 10 mg group as compared to the 20 mg group (P<0.05).Significantly greater (P<0.05) number of patients reached target LDL levels with a dose of 20 mg. There was no dose related association of adverse events. Conclusions: Starting patients at higher doses of atorvastatin can be accomplished without compromising safety. Physicians are likely to have greater success in achieving LDL-C goals if they select the starting dose of atorvastatin according to the percentage reduction in LDL-C required and not only on the basis of the patients cardiovascular risk.

CVS-6

Effect of enalapril and ramipril on serum lipid profile in albino rabbits.

Chandra S. , Singh S.P., Jain I.P., Singh S., Kushwaha V.

Department of Pharmacology and Therapeutics, G.S.V.M. Medical College, Kanpur - 208 002, Uttar Pradesh, India.

Objective : Hypertension with dislipidemia is becoming a common morbidity, since ACE inhibitors are the first line of antihypertensive drugs so present study was undertaken with the aim to evaluate the possible effects of ACE inhibitor on lipid profile in albino rabbits. Material and Methods: The study was conducted in the Dept. of Pharmacology and Therapeutics, GSVM Medical college, Kanpur. Rabbits were divided into 2 groups with 6 in each group. Each group served as its own control. Rabbits of Group I were given Enalapril in dose of 0.50 mg/kg and of group II were given Ramipril in dose of 0.25 mg/kg for a period of 6 weeks. Lipid profile estimation (Serum Total cholesterol, serum HDL, serum LDL, serum Triglycerides and serum VLDL) was done at day 0, 7, 21 and 45 respectively. Results : Statistical analysis was carried out by using paired t-test. Rabbits of group-I (Enalapril) showed 7% decrease in serum cholesterol level at 45 th day when compared with the level on day 0, found to be statistically significant (P<0.05). Serum HDL level increased by 10% and 20% at day 21 and 45 respectively (P<0.05). Serum Triglyceride level increases by 8% at day 45 (P<0.05). Serum LDL level decreases by 7.8% and 16% at day 21 and 45 respectively (P<0.05). There was no significant change in Serum VLDL level. Rabbits of group- II (Ramipril) showed increase in HDL level by 7% and 12% at day 21 and 45. (P<0.05). Total cholesterol, triglycerides and VLDL levels were not significantly altered while serum LDL level decreases by 6.8% at day 45. (P<.05). Conclusion: It was concluded that enalapril had a favourable effect on serum lipid profile by decreasing total cholesterol, increasing serum HDL level. It may increase triglycerides, decrease LDL. Ramipril increase serum HDL and decreases LDL, there is no significant change in cholesterol, TG and VLDL levels.

CVS-7

Scientific validation of three cardio protective polyherbal formulations on patients with both hypertension and hyperlipidemia


P. L Palatty, Simon A.R , Meera Sharke

Father Muller Medical College, Kankanady, Mangalore, India.

Objective: Effect of Ayaskrithi, Hridayarnava Rasa, Triphaladi choorna on selected cardiac parameters. Materials and Methods: Thirty patients attending an ayurvedic clinic having both hyperlipidemia and hypertension were selected and allocated to the three poly herbal formulations (Ayaskrithi, Hridayarnava Rasa, Triphaladi choorna), ten patients each. Baseline investigations of B.P,FBS, PPBS, Creatinine, CPK, SGPT, SGOT, Cholesterol, Triglyceride, HDL, LDL, VLDL, Total Cholesterol/ HDL were done and taken as the cardiac parameters for the study. Inclusion criteria included patients screened for any major cardiac illnesses and having a normal ECG for ethical reasons. The selected parameters were checked at 0 Baseline, 30, 60 and 90 days. Type of study: Cross sectional prospective descriptive study. Results: The ANOVA F value was highly significant for Hridayarnava Rasa and Triphaladi choorna in lowering BP and cholesterol for Hridayarnava Rasa the F value=18.74 and P value=0.001. For Triphaladi choorna the F value=14.45 and P value=0.001. Hridayarnava Rasa also showed a F value=6.64 and P value=0.002 with LDH which is highly significant. Hridayarnava Rasa also showed a highly significant reduction in SGOT with a F value=4.706 and a P value=0.009 Triphaladi choorna is significant in reducing LDH levels with a F value=3.602 and a P value=0.026. Conclusion: Despite great strides in understanding cardio vascular disease and technological advancement the optimal therapy is still elusive. Hridayarnava Rasa and Triphaladi choorna showed significant reduction in the parameters of BP, cholesterol and LDH and SGOT, while Ayaskrithi was not shown to be significantly as effective. Appreciable effects were seen only after 3 rd month. These cardio protective polyherbal formulations need scientific validation as cardiovascular diseases dominate the cardiac mortality and morbidity profile of the world and India in particular.

CVS-8

Study of current trends in treatment of cardiovascular disorders: A pharmacoepidemiological overview

Gunjan Sharma , Veeranjaneyulu Addepalli 1 , Meena Chintamaneni 1 , Devarati Majumdar 2

Amity University, Noida, 1 School of Pharmacy and Technology Management, NMIMS University, Mumbai, 2 Max Health Care Instt. Ltd., New Delhi, India.

Objective: To study the concurrent trend in treatment of cardiovascular disorders so as to achieve even faster and efficacious results in future. Materials and Methods: A study was conducted from Sep'08 to Jan' 09 on pharmacological therapy of 208 patients suffering from cluster of cardiovascular disorders. ANOVA test (P>0.05 at 95% CI) and t- test were applied on results for statistical evaluation. Results: It was found that amongst 208 patients suffering from Coronary Artery Disease (CAD), only 13% were having it in isolation and the rest major population of 87% was having CAD as a co morbid condition with other cardiovascular diseases like Hypertension and Diabetes Mellitus. In the patients having cluster of cardiovascular diseases, 42.64% (64 of 208) had hypertension, 14.67% (22 of 208) had Diabetes Mellitus as co morbid condition and also higher number of patients i.e. 30% (45 of 208) were having all the three disorders. One more outcome of the study was the effect of age factor. More than half population i.e. 56.45% patients lie in the age group of 50 yrs to 70 yrs. 18% of these patients are managed by monotherapy where as 76% are managed by combination therapy with two or more than two antihypertensive drugs. Also a small group of patients i.e. 5.7% (12 of 208) were treated only with Antiplatelet and Hypolipidemic drugs. Also, amongst antihypertensive drugs the combination of ACE inhibitor with Beta Blocker gave best results in patients of CAD irrespective of co morbidity present. Conclusions: Hypertension and Coronary Artery Disease frequently occurs in cluster of other cardiovascular diseases, maximally in the age group of 50 yrs to 70 yrs. It is best managed with the combination of two to three antihypertensive drugs with antiplatelet and hypolipidemic drugs in their synergism along with advised lifestyle modification.

CVS-9

Awareness of hypertensive guidelines among medical practitioners of District Hospital and Government Medical College

Misra P. , Zia F., Bindra H., Nim D.K., Goel B., Chaurasia R.C.

Motilal Nehru College, Allahabad, U.P.

Objective: Unsatisfactory blood pressure (BP) control in the hypertensive patient is not only related to poor compliance but is also explained by insufficient physicians' awareness of experts' guidelines. Study was done to assess awareness of current recommendation about hypertension awareness among medical practitioners of district hospital and government medical college. Materials and Methods : A questionnaire was prepared containing MCQs to assess awareness of hypertensive guidelines among medical practitioners. The number of answers in agreement with World Health Organization (WHO)/International Society of Hypertension(ISH) guidelines was used as an awareness measure. This was considered adequate, if correct answers to 6 out of 10 questions, including an appropriate definition of hypertension was provided. Physicians' perception of BP control among their patients was also requested at the end of questionnaire. Results: Of the 200 questionnaires given, 181 questionnaires were returned (a 90.5% response rate), 163 were suitable for analysis. The mean score of correct answers was 4.2 points and only 14.7% of the study population correctly answered at least 6 of the questions (including that on the definition of hypertension in the elderly). Guidelines awareness was inversely related to increase in physicians' age and duration of clinical practice. Physicians who reported a high rate of achieved BP control had a lower rate of adequate knowledge than those who reported less-successful therapeutic results. Finally, physicians of district hospital had significantly lower prevalence of adequate guidelines awareness as compared to medical college physicians (P<0.05). Conclusion : This survey shows that a sufficient degree of guidelines awareness is present only in a minority of medical practitioners. Therefore, further efforts are required to intensify information strategies for improving professional education, training and practice organization aimed at achieving therapeutic goals.

CVS-10

Interaction of garlic oil and its constituents, diallyl disulfide, with atenolol in isoproterenol induced myocardial injury in rats

V.V. Srujan Kumar , Pulla Reddy Avula, Syed Mohammed Basheeruddin Asdaq, Suresh Kumar Nagpal, Rajesh Kumar Rawri 1

Departments of Pharmacology, 1 Pharmaceutical Chemistry, Krupanidhi College of Pharmacy, Varthur Hobli, Chikkabellandur Village, Carmalaram Post, Bangalore-560 035, India

Objectives: The present study was performed to evaluate the role of garlic oil (GO) and its active constituent, diallyl disulfide (DADS), individually or when administered concurrently with atenolol for ameliorating the myocardial damage induced by isoproterenol in rats. Materials and Methods: Based on the GCMS peaks of GO, the doses of DADS was selected (4.47 and 8.94 mg/kg). Animals were administered GO 50, 100 mg/kg, DADS 4.47, 8.94 mg/kg individually in their respective groups or in combination with ATN (6 mg/kg) for three weeks alternative days. At the end of treatment, two doses of ISO (150 mg/kg, sc) were administered to rats. Blood samples were collected to evaluate LDH and CK-MB activities. Hearts were excised from anaesthetized animals and heart tissue homogenate (HTH) was prepared to estimate LDH, CK-MB as well as SOD and Catalase. Results: Subcutaneous administration of ISO caused elevated serum LDH, CKMB activities with a subsequent decline in HTH. Groups treated with ISO, GO high dose and GO low dose +ATN showed significant increase in the serum LDH compared to normal control. Among the various groups, garlic oil low dose and high dose of DADS are equally potent indicating the presence of additional active constituents in GO responsible for cardioprotective behaviour. Conclusions: Efficacy of garlic oil was further augmented when used in combination with ATN in combating myocardial dysfunction and metabolic derangement. Hence caution should be exercise while using garlic oil with atenolol.

CVS-11

The potential for interaction of gliclazide and ramipril with garlic during myocardial damage in diabetic rats

Kedarinath T. , Suresh Kumar V., Syed Mohammed Basheeruddin Asdaq, Prem Kumar N., Suresh Kumar Nagpal, Rajesh Kumar Rawri 1

Departments of Pharmacology, 1 Pharmaceutical Chemistry, Krupanidhi College of Pharmacy, Varthur Hobli, Chikkabellandur Village, Carmalaram Post, Bangalore-560 035, India.

Objectives: The present study was designed to evaluate the cardioprotective potential and anti diabetic effect of garlic alone and in combination with gliclazide (GLI) and ramipril (RAM) in diabetic animal subjected to ischemia reperfusion injury (IRI). Materials and Methods: The Male Sprague dawley rats were randomly allocated into eight groups. Diabetes was induced by a single dose of alloxan 150 mg/kg (i,p). Three days subsequent to Alloxan treatment, blood glucose levels were checked. Those animals with established serum glucose levels >/300 mg/dl were selected for our experiments. Subsequently, GH was administered for 30 days, whereas, GLI and RAM were given for 10 days in both interactive and individual groups. At the end of treatment, heart was excised from deeply anesthetized rat and perfused with Kreb-Henseleit solution gassed with carbogen at 37 o C. Further, hearts were subjected to global no flow ischemia for induction of myocardial damage. Perfusate collected during post ischemia and heart tissue homogenate (HTH) were subjected to biochemical studies which were later confirmed by histological studies. Results: Experimental diabetic model in IRI suggests that GH alleviated the myocardial damage in diabetic animal during IRI. The GLI and RAM demonstrated some cardioprotective effect. Among all GH+RAM was most effective in reverting the damages due to IRI. The protective behavior of GH was further augmented when used along with RAM. Conclusions: The observations suggest the cardioprotective behavior and antidiabetic potential of GH when used alone or in combination with RAM and GLI in diabetic rats.

CVS-12

Abana® , A Polyherbal Formulation Inhibits Platelet-aggregation in both In vitro and In vivo Experimental Models

Vishwanath G.L ., Jagadeesh M., Rajesh S., Thippeswamy A.H.M., Patki P.S., Mohamed Rafiq

Department of Pharmacology, R and D Centre, The Himalaya Drug Company, Makali, Bangalore, Karnataka, India.

Objective:
The present study was aimed to evaluate the effect of Abana® - a polyherbal formulation on in vitro platelet aggregation-induced by different agents and also in occlusion-induced deep vein thrombosis in rats. Materials and Methods: The anti-platelet property of Abana was evaluated by using ADP (Adenosine- 5, 5'- di phosphate) and adrenaline-induced platelet aggregation models using platelet rich plasma (PRP) separated from rat blood, while anti-thrombotic activity was evaluated against occlusion-induced deep vein thrombosis model in wistar rats. Results: ADP and adrenaline are well known and commonly used platelet aggregating agents for screening anti-platelet activity, In present study both ADP and adrenaline have showed dose dependent increase in platelet aggregation in PRP separated from rat blood. Abana® dose dependently alleviated ADP and adrenaline induced-platelet aggregation in in vitro conditions. Occlusion-induced deep vein thrombosis is the most popular method for screening the antithrombotic potential. In present study, Inferior venacaval ligation (IVC) caused prominent thrombus formation in the occluded region the vena cava in wistar rats; Abana® 5 days pretreatment to rats howed significant dose dependent protection against occlusion induced deep vein thrombosis in rats. Conclusion: Abana® , a polyherbal formulation possesses anti-platelet and antithrombotic effect in the experimental models of invitro platelet aggregation and deep vein thrombosis in rats, which could account for one of the mechanism of its beneficial activity observed in cardio and cerebrovascular cases.


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END-1

Efficacy of pioglitazone hydrochloride in combination with metformin versus metformin and placebo in the treatment of type 2 diabetes mellitus: a randomized study.

Trivedi M. , Chansoria A., Shukla P., Shukla K.N. 1 , Verma V.K., Ahmed A.

Department of Pharmacolgy, Era's Lucknow Medical College Sarfarzganj, Hardoi Road Lucknow, 1 Department of Medicine, Balrampur Hospital, Lucknow, Uttar Pradesh, India.

Objective : 0 This study assessed the efficacy and tolerability of pioglitazone in combination with metformin v/s metformin in patients with type 2 diabetes mellitus. Materials and Methods : 0 A 16-week, double-blind study included drug naïve patients with not well controlled diabetes mellitus (glycated hemoglobin [HbA1c] > or =8.0% was conducted, Patients with any complication of diabetes, CVS , etc. were excluded. Patients were randomized to receive once-daily pioglitazone 30 mg + metformin or placebo + metformin. Results : 0 One hundred sixty four patients were randomized to treatment (84 pioglitazone + metformin, 80 placebo + metformin), and 124 completed the study. Patients receiving piogli- tazone 30 mg + metformin had statistically significant mean decreases in HbA1c (-0.88%) and fasting plasma glucose (FPG) levels (-38.0 mg/dL) compared with placebo + metformin (P < or = 0.05). Decreases in FPG levels occurred as early as the fourth week of therapy, the first time point at which FPG was measured. The pioglitazone + metformin group had significant mean percentage changes in levels of triglycerides (-17.8%) and high-density lipoprotein cholesterol (+8.9%) compared with placebo + metformin (P < or = 0.05). Mean percentage increases were noted in low-density lipoprotein cholesterol levels (7.9%, pioglitazone + metformin; 12.1%, placebo + metformin) and total cholesterol (4.3%, pioglitazone + metformin; 1.4%, placebo + metformin), with no significant differences between groups. The incidence of adverse events was similar in both groups. Conclusions : 0 In this study in patients with type 2 diabetes mellitus, pioglitazone + metformin significantly improved HbA1c and FPG levels, with positive effects on serum lipid levels

END-2

Study on awareness of safety aspect of emergency contraception

Patil S.U. , Lalan B.K., Deshpande P.K., Ghongane B.B.

Department of Pharmacology, B.J. Medical College and Sassoon General Hospital, Pune-411 001, Maharashtra, India.

Objectives : To test knowledge about safety aspect of emergency contraception. Materials and Methods : A questionnaire was circulated which paid special attention to the safety aspect of the use of emergency contraception. 250 people were enrolled out of which 100 were from medical field (Groups- I :Medicos), 100 from IT sector(Group-II :Non-medicos.and 50 people were patients (Group-III :patients) from a peripheral health centre. The responses to the questionnaire were obtained and stastistical analysis done.Then the study population was given information sheets containing latest drugs and highlighting safety aspect. The questionnaire was given again and answers were re-obtained. Results : There was an equal awareness about emergency contraception amongst all the groups



Conclusion: Awareness about the safety aspect was significantly lacking in all the groups. Providing information sheets is an useful tool to improve knowledge and awareness

END-3

Antioxidant stratus in streptozotocin induced diabetic rats and effect of aqueous extract of Murraya koenigii leaves on it

Sudha M.J. , Seethalakshmi, Mohandas Rai, Kumaraswamy

Department of Pharmacology, A J Institute of Medical Sciences, Mangalore-575004, India.

Background and Objectives: Free radicals may play an important role in causation and complications of Diabetes Mellitus. Abnormally high level of free radicals and the simultaneous decline of antioxidant defense mechanisms can lead to damage of cellular organelles and enzymes, increased lipid peroxidation, and development of insulin resistance. These consequences of oxidative stress can promote the development of complications in diabetes mellitus. Materials and Methods: Diabetes was induced in Wistar rats by intraperitoneal injection of streptozotocin (75 mg/kg body weight). The antioxidant status of these diabetic rats was determined by estimating levels of Malondialdehyde (MDA) and catlase in RBC hemolysate and Total Antioxidant Activity in plasma after 6 weeks and was compared with normal control rats. These levels were assessed in the same rats after 6 weeks of oral administration of aqueous extract Murraya koenigii leaves (MKL). Results : The levels of malondialdehyde in RBCs were increased in diabetic rats as compared to normal controls after 6 weeks of induction of diabetes. The level of catalase was lower in RBC hemolysate of diabetic rats as compared to normal controls. The total antioxidant activity was depleted in diabetic rats. After administration of MKL extracts these parameters showed significant improvement. Conclusions: The results indicate that increased oxidative stress and accompanying decrease in antioxidants may be related to the causation of diabetes mellitus. MKL extract has significant impact on improvement of antioxidant status of diabetic process.

END-4

Congenital anomalies in male newborn, associated with letrozole use in healthy 25 years old woman having anovulatory infertility

Mistry R.A. , Singh A., Nayak B. 1 , Trivedi H.R.

Departments of Pharmacology, and 1 Obstetrics and Gynaecology, M.P. Shah Medical College, Jamnagar, Gujarat, India.

There are no published case reports of letrozole (aromatase inhibitor) induced congenital anomalies like Anencephaly, Cervical vertebral fusion, Spina bifida (Cervicothoracic level) and lowerlimb bone deformity in male newbrn baby of 25 years old woman, taking letrozole for primary anovulatory infertility. Here we report such a case. Patient had taken treatment with tablet letrozole (Letroz: Sunpharma), 2.5mg, from 2 nd day of menses for 5 days for such 3 cycles in government hospital. Before that Patient was already given such 6 cycles from private hospital,but patient didn't give that history initially when asked before prescribing letrozole in government hospital. Regular followups by USG were done since starting of treatment, USG report of 1 month and 10 days of completion of therapy showed congenital anomalies in male newborn and so termination of pregnancy was advised. As per WHO Causality assessment,it falls in a "possible" adverse drug reaction. Gynaecologists must keep in mind of such rare and serious side effect before prescribing letrozole for anovulatory infertility.

END-5

A study on effect of combination of tramadol and paracetamol on blood glucose level in type 2 diabetes patients suffering from osteoarthritis

Acharya Abhishek , Somashekar H.S., Kiran L.J., Ramakrishna Santhosh, C.G. Gokul, Adake Prabhakar

Department of Pharmacology, JJM medical college, Davangere, India.

Objectives : To study the effect of combination of tramadol and paracetamol on blood glucose level in type 2 diabetes patients suffering from osteoarthritis. Materials and Methods: This is an observational study conducted in one of the private hospitals in Davangere by recruiting 60 patients of 35yrs and older having been diagnosed with type 2 diabetes mellitus and osteoarthritis and was on oral antidiabetic medications. These patients were given fixed dose combination of tramadol and paracetamol twice daily for not less than 1 week and blood glucose levels were compared before and after the treatment with fixed dose combination of tramadol and paracetamol. Results: The results showed a mean drop in fasting blood glucose levels by 26.5mg/dl with a p value of <0.001 and a mean drop of postprandial blood glucose level by 28.7mg/dl with a p value of <0.01. These results showed a significant reduction of blood glucose level in type 2 diabetes patients receiving fixed dose combination of tramadol and paracetamol for osteoarthritis. Conclusion: The study shows that fixed dose combination of tramadol and paracetamol has a significant blood glucose lowering capacity in patients of type 2 diabetes. However, further studies are required to conclusively know the exact mechanism of blood glucose lowering action.

END-6

To study the antidiabetic activity of vanadium and chromium compounds in normal and streptozotocin induced diabetes in experimental animals


Bezbaruah B.K., Lahkar M., Pathak P.

Department of Pharmacology, Gauhati Medical College, Narakachal Hill Top, Bhangagarh, Guwahati - 781 032, Assam, India.

Objectives: The present study had been undertaken to study the antidiabetic activity of Vanadium and Chromium compounds in normal and streptozotocin induced diabetes in experimental animals. Materials and Methods : A total of 54 rats were divided into the following groups with 6 animals in each group. Group-A: Normal control: normal saline 5ml/kg. Group-B: Diabetic control group: normal saline 5ml/kg. Group-C: Diabetic test group (Vanadium)-Group C(i)Vanadium pentoxide 5mg/kg, Group C(ii)Vanadium pentoxide 10 mg/kg. Group-D: Diabetic test group (Chromium)- Group D(i): Chromium oxide 10 mg/kg, Group D(ii):Chromium oxide 20 mg/kg. Group-E: Diabetic standard group: Glibenclamide 0.5 mg/kg. Group-F: Test control: Vanadium Pentoxide 10 mg/kg. Group G: Test control: Chromium oxide 20 mg/kg. All the above groups were fed orally for 10 days. Diabetes was induced by single intraperitoneal injection of streptozotocin 60 mg/kg. Results : In diabetic rats, Vanadium pentoxide (5 mg/kg and 10 mg/kg) and Chromium oxide (20mg/kg) gives statistically significant (P<0.05) hypoglycemic effect compared to control group. Conclusion : The observations in the present study lead to the conclusion that Vanadium and Chromium compounds have antidiabetic properties.

END-7

Protective effects of seabuckthorn (Hippophae rhamnoides l.) In streptozotocin-nicotinamide induced type-2 diabetic rats

Manju Sharma , M. W. Siddique, Mohd. Shamim Akhter, Gyanesh Shukla 1 , K.K. Pillai

Department of Pharmacology, Jamia Hamdard (Hamdard University), New Delhi, 1 Herbal Drug Research, Ranbaxy Laboratory, Gurgoan, Haryana, India.

Objective: The present study is aimed at finding the antidiabetic and antioxidant effect of sea buckthorn (Hippophae rhamnoides L.) in streptozotocin-nicotinamide induced type-2 diabetic rats. Materials and Methods: Experimental diabetes was induced by a single intraperitonial injection of streptozotocin (60 mg/kg), 15 minutes after the i.p. administration of 120 mg/kg nicotinamide. Seabuckthorn was administered orally to STZ diabetic rats. Blood glucose, tissue glutathione (GSH) and thiobarbituric acid reactive substances (TBARS) in pancreas were estimated following the established procedures. Biochemical observations were supplemented with histological examination of pancreatic tissue. Results: The increase in blood glucose levels, TBARS level with reduction in GSH content were the salient features observed in STZ- diabetic rats. Sea buckthorn produced a significant (p< 0.05) lowering of blood glucose levels in the STZ- diabetic rats. Glutathione (GSH) that was reduced significantly (p< 0.05) in diabetic rats, was brought back to near normal levels by co-administration of seabuckthorn. The lipid peroxides were increased in STZ diabetic animals. Seabuckthorn reduced the lipid peroxides level in diabetic animals. Degenerative changes of pancreatic beta cells in STZ- diabetic rats were minimized to near normal morphology by administration of sea buckthorn as evident by histopathological examination. Conclusion: The results of the study indicate the role of oxidative stress in the induction of diabetes and suggest antidiabetic and antioxidant effect of sea buckthorn in this animal model.

END-8

Effect of quetiapine on blood glucose levels in rats


Amit Jadhav, Charles.V. Adhav , V.S. Chawan, Nisha Jadhav, P.R. Pandit, K.A Bhave

Department of Pharmacology, Topiwala National Medical College and B.Y.L. Nair Ch. Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai- 400 008, India.

Objectives: To evaluate the effect of quetiapine on blood glucose levels in rats on acute and repeated daily administration over a period of 14 days at 18,36 and 72 mg/kg. Materials and Methods : 24 albino wistar rats were divided in 4 groups of 6 rats each. Rats were fasted overnight before the study. Group 1 received 1% carboxy-methylcellulose in distilled water, orally as vehicle control. Group 2, 3 and 4 received 18, 36 and 72 mg/kg of quetiapine orally resp. for 14 days. Blood was collected using Tail pin prick method on day 1 at 0, 2,4,6,8 hours on day 3, 7, 14 at 0 and 4 hours. Blood glucose levels were estimated using glucometer and glucose strips. Results: Quetiapine, on acute and daily repeated administration orally for 14 days maintained the baseline blood glucose levels for atleast 4 hours only at a high dose of 72 mg/kg. This effect was not seen with low and moderate doses of Quetiapine. Conclusion : Diabetic patients suffering from psychosis on treatment with quetiapine should be monitored for blood glucose levels.

END-9

Effect of hydroalcoholic extract of cinnamomum tamala leaves on serum glycocylated hemoglobin in diabetic rats


Rupesh Soni, Narendra Yadav 1 , D. N. Srivastava 1

Faculty of Pharmaceutical Sciences, Jodhpur National University, Jodhpur, Rajasthan, 1 B. R. Nahata College of Pharmacy, Mandsaur, Madhya Pradesh, India.

Introduction : Diabetes is a metabolic disorder which occurred due to some changes in carbohydrate, protein and fat metabolism. In presence of high blood glucose level the metabolites of glucose or carbohydrate metabolism react with essential proteins of blood like hemoglobin and formed a new product called as glycocylated hemoglobin. This glycated Hb reduces the oxygen carrying capacity of blood and causes several pathophysiological changes in body. Which are harmful and can produces chronic diabetic disorders. Cinnamomum tamala leaves have been used by investigators as antidiabtic. So our aim is to study effect of hydroalcoholic extract of cinnamomum tamala leaves on serum glycocylated hemoglobin in alloxan induced diabteses in rats. Materials and Methods : Wistar albino rats were made diabetic by single intraperitneal injection of alloxan monohydrate 120 mg/kg and serum glycocylated hemoglobin level was estimated by NBT reduction method of Somani BL et al 1985. Results : The hydroalcoholic extract of cinnamomum tamala leaves treated rats showed decreased amount of serum glycocylated hemoglobin and blood glucose level as compared to diabetic control rats. Conclusion : The above study concludes that hydroalcoholic extract of cinnamomum tamala leaves can be effective in treatment of diabetic complications and glycocylated hemoglobin related disorders.

END-10

Is hexokinase activator attenuates diabetes and associated endothelial dysfunction in rats?

Kanzariya N.R.* , Patel E.D., Patel Rameshvar K., Patel N.J.

Department of Pharmacology, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, India.

Objectives: Hexokinase is the rate limiting enzyme involved in the glycolysis. Decreased hexokinase levels were found in diabetic rats. So our main aim of the project was to find out the effect of hexokinase activator in diabetes and associated endothelial dysfunction in rats. Materials and Methods: Type 2 diabetes was induced by high fat diet and low dose of streptozotocin. Diabetic rats were divided into diabetic control and magnesium treated groups. Magnesium was used as a hexokinase activator. The treatment was given for 4 weeks. Various biochemical parameters were measured before initiation and the end of treatment. Hepatic hexokinase activity was measured in diabetic and various treated rats. Systolic blood pressure was measured by the non-invasive tail-cuff method, while various biochemical and tissue parameters were estimated for efficacy. Endothelial dysfunction was checked by taking the relaxation responses of Acetylcholine (10 -10 M to 10 -6 M) in phenylephrine induced precontractile rat thoracic aortas of different groups. Statistical comparisons between all groups were performed by using two-tailed one-way ANOVA followed by the Dunnett test. P-values <0.05 were considered statistically significant. Results: Treatment with magnesium significantly increases hexokinase activity while reduced the augmented systolic blood pressure, various biochemical parameters, and antioxidant parameters in diabetic-treated rats. Treatment also showed the increase in acetylcholine induced relaxation responses in rat thoracic aortas of treated rats. Conclusions: We can conclude that magnesium treatment reduces the diabetic state as well as diabetes associated endothelial dysfunction. Hence, hexokinase activator may be the newer target for the treatment of diabetes.


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GIT - 1

Study of the anti-ulcerogenic activity of the ethanolic extracts of tuber of curcuma caesia against gastic and duodenal ulcers in experimental animals

Bordoloi P., Phukan D., Das S.

Department of Pharmacology, Assam Medical College and Hospital, Dibrugarh-786002, Assam, India.

Objective: To study the anti-ulcerogenic activity of the ethanolic extracts of tuber of Curcuma caesia (EECC) against gastric and duodenal ulcers in experimental animals. Materials and Methods : Healthy albino rats of either sex weighing 100-150 g were taken and divided randomly into four groups of five animals in each group for evaluation of anti- ulcerogenic activity of EECC by pyloric ligation method. Group A received gum acacia orally for 7 days. Group C and D received EECC (500 mg/kg orally) and ranitidine (150 mg/kg) for 7 days respectively. On 7 th day, Group B, C and D received aspirin 400 mg/kg orally as a single dose. After 24 hours of aspirin administration, pyloric ligation was done in all animal groups and they were kept for 4 hours. Thereafter rats were sacrificed and their stomachs were removed to measure the (1) ulcer index (2) pepsin activity, (3) gastric mucus,(3)free acidity, (4) total acidity, and (5) gastric volume. Results: One way ANOVA followed by Dunnett's multiple comparison tests were used for statistical analysis of the results. Values of <0.05 were considered significant. The ulcer index, pepsin activity, free and total acidity showed a significant decrease P<0.05, whereas there was increase in gastric mucus secretion in Group C and D. The reverse was seen in Group B. Conclusion: The study showed that Curcuma caesia has an anti-ulcerogenic effect similar to that of Ranitidine.

GIT-2

Screening of Doronicum hookeri root extracts for hepatoprotective and antioxidant activity in CCl4 treated rats

Syed S.N. , Rizvi W., Kumar A., Khan AA. 1 , Moin S. 2

Department of Pharmacology, JNMC, AMU, Aligarh, 1 Department of Anatomy, JNMC, AMU, Aligarh, 2 Department of Biochemistry, JNMC, AMU, Aligarh, Uttar Pradesh, India.

Objective: To evaluate the hepatoprotective and antioxidant activity of aqueous and ethanolic extract of root of Doronicum hookeri. Materials and Methods: The aqueous and ethanolic extracts were prepared by soxhalet extraction method. The rats (200-250 gms) were divided into 6 group (n=6). (Control - Vehicle, Positive control - Silymarin, Negative control- CCl 4 and Test group -aqueous (500mg/kg) and ethanolic extract (300 and 500mg/kg). The test drug and CCl 4 (Dose- 1ml/kg in olive oil in a ratio of 1:1) were given orally for 7 days. On the 8 th day the animals were sacrificed and blood was collected for biochemical parameters like AST, ALT, ALP and TOTAL BILURUBIN. The liver tissue was used for histopathological examination and antioxidant tests viz. Superoxide dismutase (SOD), catalase (CAT), Glutathione Reductase (GSH) and Malonlydialdehyde (MDA). Results: The Ethanolic extract showed significant dose dependent reduction of AST, ALT, ALP and Total Bilurubin as compared to CCl 4 control group. In case of antioxidant enzymes, the alcoholic extract significantly increased SOD, CAT, GSH enzymes and decreased the activity of MDA. The findings were confirmed by histopathological examination. The aqueous extract activity was found to be less effective in reducing the liver biomarkers as compared to ethanolic extract of root of Doronicum hookeri. Conclusion: On the basis of our finding we can conclude that the ethanolic extract of Doronicum hookeri has some role in protecting the hepatocytes from CCl4 induced injury.

GIT-3

To evaluate the hepatoprotective activity of Berberis aristata in CCl4 induced hepatotoxicity in rats.

Pawar U. , Nasiruddin M., Khan R.A., Khan A.A. 1 , Tajuddin 2

Department of Pharmacology, J.N.M.C.H, A.M.U, Aligarh, 1 Department of Anatomy, J.N.M.C.H, A.M.U, Aligarh, 2 Department of Ilmul Advia, A.K.T.C, A.M.U, Aligarh, Uttar Pradesh, India.

Objective: To evaluate the hepatoprotective activity of freeze dried aqueous and ethanolic extract of stem of Berberis aristata in CCl 4 induced hepatotoxicity in albino wistar rats. Material and Methods: The aqueous and ethanolic extracts were prepared by soxalate extraction method and then freeze dried. The albino wistar rats (200-250 gms) were divided into 6 groups with 6 animals each. Control - Vehicle, Positive control - Silymarin, Negative control- CCl 4 and Test group -aqueous (300mg/kg) and ethanolic (300 mg/kg). The test drugs were given orally for seven days while CCl 4 (Dose- 2ml/kg in liquid paraffin at a ratio of 1:1) was given intraperitoneally on 7 th day. On the 8 th day the animals were sacrificed and blood was collected for biochemical parameters like AST, ALT, ALP, TOTAL BILURUBIN . The liver tissue was used for histopathological examination. Results: The Freeze dried aqueous extract showed significant reduction of AST, ALT, ALP, TOTAL BILURUBIN as compared to CCl 4 control group. The freeze dried ethanolic extract activity was found to be less effective in reducing the liver biomarkers as compared to freeze dried aqueous extract of stem of Berberis aristata. Conclusion: So it is inferred that the freeze dried aqueous extract of stem of Berberis aristata protect the liver form CCl 4 injury as demonstrated by liver function tests.

GIT-4

Study of the anti-ulcerogenic activity of the ethanolic extracts of leaves of Paederia foetida L. against gastric and duodenal ulcers in experimental animal models.

Singh R. , Das S.

Assam Medical College and Hospital, Dibrugarh, Assam, India.

Objective: To study the anti-ulcerogenic activity of the ethanolic extracts of leaves of Paederia foetida L. (EEPF) against gastric and duodenal ulcers in experimental animal models. Materials and Methods: Healthy albino rats of either sex weighing 150-200 gms were taken and divided randomly into four groups of five animals in each for evaluation of anti-ulcerogenic activity of EEPF against aspirin induced gastric and duodenal ulcers. Group A received gum acacia orally for 7 days. Group C and D received EEPF (500mg/kg orally) and ranitidine (150 mg/kg orally) respectively for 7 days. On 7th day, Group B, C and D received aspirin 400 mg/kg orally as a single dose. After administration of aspirin, the animals were fasted overnight and had water ad libitum. On the 8th day, pyloric ligation was performed on all the rats under light anaesthesia and kept for 4 hours. Thereafter.the rats were sacrificed by proper doses of ether and the stomachs were removed and the contents collected in test tubes for analysis. The mucosa of the stomach and duodenum was examined for ulcers and subjected to gastric mucus estimation. Result : EEPF significantly reduced the ulcer index in aspirin-induced gastric and duodenal ulcers (P<0.05). Analysis of the gastric contents showed significant decrease in total acid, free acid and pepsin content and significant increase in the mucus content by EEPF indicating anti-ulcerogenic activity. Conclusion : The finding suggests that the ethanolic extracts of leaves of Paederia foetida L. possess significant anti-ulcerogenic activity.

GIT-5

Hepatic metabolism of ibuprofen under acute hypobaric hypoxia in rats

Shefali Gola , Gaurav K. Keshri, Asheesh Gupta

Defence Institute of Physiology and Allied Sciences, DRDO, Lucknow Road, Timarpur, Delhi - 110 054, India.

Background: Induction to high altitude (HA) affects the drug metabolic capacity of the body. Due to altered drug metabolism and pharmacokinetics, the drug dosage required for safe and effective therapy may differ at HA and therefore it is necessary to ensure safe drug dosage regime. Objective: In the present study, the effect of hypobaric hypoxia on hepatic drug metabolism of ibuprofen was evaluated under acute hypoxia exposure in experimental rats. Materials and Methods: Animals were exposed to altitude of 7620m (~25,000 ft) for acute exposure (6 and 24 hr) in decompression chamber. Ibuprofen (80 mg/kg body weight, PO) was administered as a candidate drug and hepatic drug metabolizing enzymes (Phase-I and II) were evaluated. Results: GST activity was significantly reduced at 6 hr (15%) and 24 hr (23%) (p<0.05) in hypoxia exposed group as compared to normoxia. Glucuronide conjugate formation showed a decreasing trend at 24 hr however no change was observed at 6 hrs hypoxia exposure. Similarly, no significant change was observed in total CYP450, NADPH Cyt c reductase, aniline hydroxylase and aminopyrine demethylase activities after acute hypoxic exposure. A significant increase in the liver function tests (LFT) viz. ALT and AST was observed. LDH activity was also found significantly increased after 24 hr hypoxia. Conclusion: The results suggest that acute hypobaric hypoxia affects GST phase II hepatic drug metabolism conjugation pathways of ibuprofen and LFT and can also impair disposition of the drug at HA due to dependency on oxygen availability.

GIT-6

Genotype phenotype correlation of Serine Protease Inhibitor Kazal Type I (SPINK I) polymorphism in chronic pancreatitis patients in a tertiary care hospital in South India

Seethalakshmi A. , Shiran Shetty, Venkatakrishnan L., Thiagarajan S., Sudha R., Ramalingam S.

PSG Center for Molecular Medicine and Therapeutics, PSG IMSR, Coimbatore, India.

Introduction: Chronic pancreatitis (CP) is a chronic progressive inflammatory disease of the pancreas. The prevalence of CP varies from 10 to 25 /100 000 populations in different countries the incidence being much higher in India. The pancreatitic secretory trypsin inhibitor SPINK1-Serine Protease Inhibitor Kazal Type 1 is secreted by the acinar cells and inhibits prematurely activated trypsin within the pancreas. The N34S mutation in Exon 3 represents the most frequent mutation in chronic pancreatitis. Studies exploring the treatment outcomes and SPINK1 mutation are very minimal in India. Aim : This study was aimed to analyze the treatment outcomes with respect to N34S SPINK1 mutation in a hospital based study conducted in India. Materials and Methods : The exon 3 of the SPINK gene was amplified and a Restriction Fragment Length Polymorphism (RFLP) analysis using SPINK F and SPINK R primers for RFLP PCR and Pst I and Bsrd I enzymes was carried out to confirm the polymorphism. Treatment outcomes were analyzed based on presence or absence of mutation. Results of the ongoing study : Of the 20 patients with CP who were evaluated for SPINK 1 N34S polymorphism, heterozygous mutation was found in 6 of 20 (30%) patients and homozygous mutation was found in 1 of 20 (5%) patients. Furthermore these findings in concert with previous reports that SPINK 1 mutation is associated with chronic pancreatitis from multiple etiologies, they also provide additional evidence that the pathologic pathway beginning with Acute pancreatitis (AP), advancing to Recurrent Acute Pancreatitis (RAP) in some patients and ultimately to Chronic Pancreatitis (CP) .Conclusion : Our study reports a possible association of SPINK I N34S polymorphism and chronic pancreatitis in our population and implying a potential novel drug target in future. In addition, results of analysis of treatment outcomes based upon SPINK1 mutation will also be presented.


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IMP-1

Impact of first line antiretroviral therapy on CD4 cell count

Pavankumar M. Daultani , Jatin G. Buch, Kiran G. Piparva

Department of Pharmacology, P.D.U. Medical College, Rajkot, Gujarat - 360 001, India.

Objectives : To analyze and compare improvement in CD4 count with first line ART regimens. Materials and Methods: This prospective, observational study was conducted in ART centre, P.D.U. Hospital, Rajkot from June 2010-June 2011.HIV positive patients of either sex of age >12 years were included. Patients of either sex, <12 years, pregnant and lactating women were excluded. CD4 count was recorded at baseline and 6 months of ART. Results: Of 294 patients enrolled, 176 ART naïve patients' data were complete and analyzed. Of 5 available antiretroviral drugs Zidovudine(Z), Stavudine(S), Lamivudine(L), Nevirapine(N), Efavirenz(E), following triple-drug regimens were prescribed; ZLN, ZLE, SLN and SLE. Out of 176 patients at initiation of ART; 92 were prescribed ZLN, 63 ZLE, 14 SLE and 7 SLN. 100 out of 176 patients were continued on same initial therapy when CD4 count was repeated at 6 months of ART (48 ZLE, 31 ZLN, 14 SLE and 7 SLN) whereas in 76 patients, ART regimen was changed during first 6 months of ART for various reasons. Mean increase in CD4 count was 165 cells/μl (p value <0.0001). Mean CD4 count increase were 218 cells/μl (p value <0.0001), 215 cells/μl (p value <0.01), 211 cells/μl (p value <0.0001) and 144 cells/μl (p value <0.0001) with SLE, SLN, ZLN and ZLE respectively. There was no statistically significant difference among ART regimens in increasing CD4 count (p value >0.05). Conclusions : There was statistically significant improvement in CD4 count at 6 months of ART but differences among various regimens for same was not statistically significant.

IMP-2

Comparative study of immunomodulatory activity of Andrographis paniculata and Tinospora cordifolia in rats and mice

Shinde B.S , Kale R.S.

Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India

Objective:
To compare immunomodulatory activity of Tinospora cordifolia and Andrographis paniculata in rats and mice. Materials and Methods: Healthy albino rats (150-200 gm) and Swiss albino mice (20-30 gm) of either sex were taken for the experiment. The hydro-alcoholic extracts of shed-dried aerated part of Andrographis paniculata and stem of Tinospoara cordifolia were given orally to rats and mice separately. To assess cell-mediated immune response neutrophil adhesion test and Cyclophosphamide-induced neutropenia were carried out while humoral immune response was evaluated by measuring sr. immunoglobulin level and indirect haemagglutination test. And comparative analysis was done. Results: On oral administration of hydroalcoholic extracts of both plants had stimulatory effect on both cellular as well as humoral immune response. But Tinospora cordifolia showed significant stimulation (P <0.01) compared to that of Andrographis paniculata in humoral as well as cellular immunity. Conclusion: Study has shown stimulatory effect of both the plant extracts on humoral and cellular immune response but Hydro-alcoholic extract of Tinospora cordifolia is more effective than hydro-alcoholic extract of Andrographis paniculata

IMP-3

Modulation of Toll like receptors in Ishikawa cell lines infected by Mycobacterium tuberculosis

Meenu S. , Thiagarajan Sairam, Ranjani S., Ramakrishnan R., Sudha Ramalingam, Ramalingam Sankaran

PSG Center for Molecular Medicine and Therapeutics, PSG IMSR, Coimbatore, India

Female genital tuberculosis is the secondary complication of primary tuberculosis and is an important cause for infertility. Mycobacterium tuberculosis colonizes the organs of the female reproductive tract like fallopian tube, endometrium, ovary, cervix and vagina to various degrees during the genital infection. The endometrium is defended against microbes by physical barriers, antimicrobial peptides, complement, Toll-like receptors (TLRs), and other pattern recognition receptors. Mycobacterial cell wall components acted as ligands to activate TLRs, especially TLR 2. The objective of this study was to evaluate the TLR 2 gene expression in vitro upon infection with Mycobacterium tuberculosis in Ishikawa cell lines. In this study, we have infected the Mycobacterium tuberculosis in the Ishikawa cell linesat the multiplicity of infection of 1:1 for four hours. The RNA was isolated from the infected cells and the control (uninfected cells). The TLR 2 gene expression was quantified by real time PCR. The TLR 2 gene expression has increased to 15.75 folds in the infected cells compared to the control while the infected cells upon incubation for 24 hours showed a downregulation to 0.5 folds. The increase in the expression of TLR2 in acutely infected endometrial cell lines could be further extended to investigate the immunopathology of the disease as well as finding novel drugs to target the proinflammatory cytokines which is responsible for the infertility associated with this disease.


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IND-1

Evaluation of the effect of Vanillin on the lipid profile in Wistar rats

Yogesh Belagali , Sheetal Ullal, Ahsan Shoeb, Ramya K., Vani Bhagwat, Rakshita M.

Department of Pharmacology, Kasturba Medical College, Mangalore - 575 001, India.

Objective : To evaluate the effect of vanillin on the lipid profile of high fat diet induced hyperlipidemic rats. Materials and Methods: Hyperlipidemia was induced by feeding cholesterol rich high fat diet for 45 days in Wistar rats of either sex.Vanillin was administered at the dose of 100mg/kg/day and 200mg/kg/day orally. It was compared with the standard drug Atorvastatin (10mg/kg/day, oral).The animals were treated with the study/standard drug during the latter 30 days of the high fat diet administration. Complete lipid profile was analyzed at the end of the study period. The data was analyzed using one-way ANOVA followed by Tukey's post hoc test. Results : Reduction in the triglycerides and VLDL-C was significant (P<0.05) at the dose of 200mg/kg of vanillin compared to atorvastatin group. Reduction in total cholesterol was significant (P<0.05) in the dose of 200mg/kg compared to hyperlipidemic control. Conclusion : The present study demonstrates that vanillin at a dose of 200mg/kg body weight lowers the serum triglyceride, VLDL-C and total cholesterol level significantly in high fat diet induced hyperlipidemic rats. However there was no significant effect on lipid profile a100mg/kg dose. There were no statistically significant changes in the HDL-C and LDL-C levels at either dose.

IND-2

Study of hepatoprotective and anti-oxidant activities of the ethanolic extract of bark of syzygium jambos on paracetamol induced liver injury in albino rats.

Garodia N. , Das S.

Department of Pharmaocology, Assam Medical College, Dibrugarh, Assam - 786 002, India.

Objectives: To study of hepatoprotective and anti-oxidant activities of the ethanolic extract of bark of Syzygium jambos (EESJ) on paracetamol induced liver injury in albino rats. Materials and Methods: Ethanolic extract of bark of Syzygium jambos was prepared by percolation method. 20 healthy albino rats of either sex weighing 100 - 150 g were taken and divided randomly into four groups of 5 rats each as follows: normal control, experimental control, test drug and standard drug. Standard drug (Silymarin at dose 100mg/kg BW) and test drug (EESJ at dose 500mg/kg BW) were given by oral ingestion for 8 days. Hepatotoxicity was induced by paracetamol ingestion at dose 5mg/kg BW on the 8th day. On the 10th day, from each group blood samples were collected and animals were sacrificed. The hepatoprotective effect was evaluated by the assay of LFT (SGOT, SGPT, ALP, total bilirubin) by auto-analyzer and histopathological studies. The anti-oxidant effect was analysed by assay of myeloperoxidase and catalase using spectrophotometer. Data were statistically analysed. Result: EESJ treated group showed significant (p<0.05) improvement of LFT and the histopathological picture as compared to the experimental control. Also the anti-oxidant effect was confirmed by improvement in the levels of myeloperoxidase and catalase levels. Conclusion: The present study showed that the ethanolic extract of bark of Syzygium jambos (EESJ) has both hepatoprotective and anti-oxidant activities.

IND-3

An In vitro Comparative Study of the Antibacterial Activity of Ethanolic Extracts of Phlogacanthus thyrsiflorus, Hottuynia cordata, Curcuma caesia and Eugenia jumbos on Clinical Isolates of Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa

Ahmed S. , Das S.

Department of Pharmacology, Assam Medical College, Dibrugarh, Assam - 786 002, India.

Objective : To study and compare the antibacterial activity of ethanolic extracts of leaves of Phlogacanthus thyrsiflorus (EEPT) and Hottuynia cordata (EEHC), tuber of Curcuma caesia (EECC) and bark of Eugenia jumbos(EEEJ) on Staphylococcus aureus, Escherichia coli and Pseudomonas Aeruginosa. Materials and Methods: EEPT, EEHC, EECC and EEEJ were prepared by percolation method. Clinical isolates of E. Coli, S. aureus and P. Aeruginosa were used for the study. Disc diffusion method for antimicrobial susceptibility testing on Mueller - Hinton agar plates was done according to the standard Kirby Bauer method. Sterilized filter paper discs of 6mm, impregnated with the plant extracts of 500mg/ml and 1g/ml were placed over the agar surface seeded with the bacterial strains. Ciprofloxacin (5μg/disc) was used as a positive control. The antibacterial activities were assessed by the presence or absence of inhibition zones after incubating the plates at 37 degree Celsius for 18-24 hours. The data was subjected to statistical analysis using one-way ANOVA followed by Dunnett's Multiple Comparison test. Values less than 0.05 were significant. Results : EEPT and EEHC showed significant antibacterial activity (inhibition zones of 12-18mm) against S. aureus, E. coli and P. aeruginosa. EEEJ showed significant antibacterial activity (inhibition zones of 11- 15mm) against S. aureus and E.coli while EECC showed significant antibacterial activity (inhibition zones of 11- 16mm) against S.aureus. Maximum zones of inhibition to S. aureus, E. coli and P. aeruginosa were exhibited by EEPT, EEEJ and EEPT respectively. Conclusion: The present study showed that the ethanolic extracts of the selected plants possess significant anti-bacterial activity. These plants could be potential sources of new antimicrobial agents.

IND-4

Evaluation of hypoglycemic activity of extract of bark of ficus bengalensis linn in alloxan induced diabetic rats

Arati C., Y.A. Maniyar

Department of Pharmacology, S N Medical College, Bagalkot, Karnataka, India.

Objective: Evaluation of Hypoglycemic activity of Extract of bark of Ficus bengalensis Linn.in alloxan induced diabetic albino rats and comparison with standard drug Glibenclamide was done. Materials and Methods: Aqueous extract of bark of Ficus bengalensis was evaluated for hypoglycemic activity. Albino rats were divided into five groups of six-animals each. Diabetes was induced by using alloxan monohydrate (180mg/kg.b.w:i.p). Control group was treated with normal saline 0.5, second group was treated with Glibenclamide 5mg/kg as a standard drug. Remaining 3 groups were treated with different doses (100,150 and 300mg/kg.b.w) of bark of F.Bengalensis for a period of two weeks. Fasting blood glucose levels was estimated using Glucometer on days 3,7and14. Results: An Aqueous Extract of F.Benglensis Linn. produced significant regulation of fasting bl.glucose in diabetic rats. The dose of 300mg/kg showed significant fall in bl.glucose level(p<0.0001) as compared to150 and 100mg/kg.b.w. Conclusions: Further studies are required to evaluate its potential antidiabetic activity. Key words: Aqueous extract, diabetes, ficus bengalensis

IND-5

Wound healing effect of extract of terminalia chebula fruit pulp in rats

V. Purohit , R.R. Ghatule, M.K. Gautam, S.R.S. Murthy, A. Singh, R.K. Goe

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

Objective : To study wound healing effects of 50% ethanolic extract of fruit pulp of T. chebula (TCWE) in rats. Materials and Methods : TCWE (600 mg/kg), suspended in 1% CMC, was administered orally once daily to C-F rats (150-200 g) for variable days depending on the type of wound ulcer study (10 days both for Incisional and Dead space wound and 24 days or earlier till complete epithelization in case of Excisional wound study). Wounds (Excisional, Incisional and Dead space) were produced in rats as per standard procedures (n=6-8). Wound contraction, epithelization period and scar area (Excisional model); wound breaking strength (Incisional model); weight of granulation tissue and antioxidants (SOD and GSH) status, levels of oxidative stress markers (LPO and NO) and connective tissue determinants (Hydroxyproline, Hexosamine, Hexuronic acid) in wet granulation tissue (Dead space wound) were evaluated. Results: Complete wound contraction and epithelization were observed at 18 th day after treatment with TCWE as compared to 24 th day in control (1% CMC) rats. Mean epithelization period and scar area were decreased while wound breaking strength was increased with TCWE compared with control. Granulation tissue showed increased levels of collagen determinants like Hydroxyproline, Hexosamine, Hexuronic acid and antioxidants (SOD and GSH) whereas markers of oxidative stress (viz. LPO and NO) were decreased in TCWE treated groups when compared with control group. The results with TCWE on the above parameters were comparable with that of Vitamin E (positive control) treated group. Conclusion : T. chebula seems to promote wound healing by enhancing connective tissue formation and antioxidants status with decrease in free radicals having tissue damaging effects.

IND-6

Healing effect of azadirachta indica leaves extract on experimental colitis in rats

R.R. Ghatule , M.K. Gautam, V. Purohit, S.R.S. Murthy, R.K. Goel

Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi - 221 005, India.

Objectives: To assess the healing effect of 50% ethanolic extract of dried leaves of Azadirachta indica (AIWE) in acetic acid (AA)-induced colitis in CF rats . Materials and Methods : Colitis was produced in rats by intracolonic administration of AA (10%, 0.2 ml). AIWE (500 mg/kg) and sulfasalazine (SS, 100 mg/kg) were orally administered to rats after induction of colitis with AA while, AA-untreated rats received NS orally and intrarectally. AIWE was studied for its effects on various physical (colonic damage score, weight and adhesions, fecal output with blood or mucous, body weight changes, food and water intake), histology and estimation of free radicals, lipid peroxidation (LPO), and nitric oxide (NO) and antioxidants, superoxide dismutase (SOD) and reduced glutathione (GSH) in colonic mucosal homogenates. Results : AA treatment led to significant increase in colonic damage score, adhesions and weight and histology showed deformed cryptae, loss of goblets cells, lymphocytic infiltration and submucosal oedema in the rat colon. AIWE showed decrease in colonic damage score, weight and adhesions and improvement in the structures with decreased lymphocytic infiltration. AA caused increase in fecal output with blood/mucous and decrease in body weight with no change in food and water intake while, AIWE treatment reversed the above effects of AA. AA showed increase in free radicals levels and decrease in antioxidants status in the colonic mucosal homogenate while the treatment with AIWE in AA-induced colitis rats showed decrease in free radicals and increase in antioxidants levels. The results were comparable with those of SS treatment . Conclusions : A. indica leaves possessed significant healing effects in AA-induced colitis which may be due to the enhanced antioxidant and free radical scavenging actions.

IND-7

Analgesic and antipyretic activities of ethanolic extract of terminalia Chebula retz. Fruit in experimental animals

Lahon J. , Lahkar M., Bezbaruah B.K., Sharma U.

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam-781032, India.

Objective: The present study was undertaken to evaluate the analgesic and antipyretic activities of ethanolic extract of Terminalia chebula Retz.(EETC) in experimental animals. Materials and Methods: The study was carried out using Wistar rats (120-130g). The EETC was prepared by Soxhlet extraction process. For analgesic activity, 24 rats were allotted to four groups of 6 animals each- Gr I: Control (Normal saline), Gr II: Standard (Morphine sulphate 5mg/kg s.c.), Gr III: EETC 400mg/kg orally, Gr IV: EETC 600mg/kg orally. Thermal stimulus-induced pain (hot plate test) was done at 0, 30, 60 and 120 min to assess analgesic activity. For antipyretic activity, 24 rats were allotted to four groups of 6 animals each- Gr I: Control (normal saline), Gr II: Standard (Paracetamol 150mg/kg orally), Gr III: EETC 400mg/kg orally, Gr IV: EETC 600mg/kg orally. Pyrexia was induced by Brewer's yeast (20mg/kg of 20% suspension in normal saline) . Results: EETC produced significant (P<0.05) increase in the mean reaction time in hot plate method at400mg/kg and 600mg/kg, oral doses. Single administration of EETC at doses 400mg/kg and 600mg/kg, orally showed significant (P<0.05) antipyretic activity throughout the observation period of 3 hours, which was comparable to the standard paracetamol group. Conclusions: The present study suggested that ethanolic extract of Terminalia chebula Retz.has significant analgesic and antipyretic activities.

IND-8

Anti-inflammatory and analgesic properties of ocimum sanctum - A comparative study using animal models

Umamageswari A. , Kudagi B.L., Amitabh Kumar, Siddalingappa C.M., Ram Mohan P.

Department of Pharmacology, Narayana Medical College, Nellore-2, India.

Objectives : To evaluate the anti-inflammatory and analgesic activity of Ocimum sanctum aqueous leaf extract in thermal and chemical induced pain and inflammatory models. To compare the anti-inflammatory and analgesic activity of Ocimum sanctum with Aspirin and Celecoxib. Materials and Methods : After obtaining Institutional Ethical Committee approval, Wistar albino rats (150-200g) and Swiss albino mice (25-30g) of either sex were randomly divided into 4 groups of 6 animals each. Dried powder of Ocimum sanctum was boiled with distilled water, cooled, filtered, placed on hotplate for complete evaporation, finally weighed and stored. The control group, test group and standard drugs group received saline, Ocimum sanctum extract (100mg/kg), Aspirin and Celecoxib respectively by oral feeding. The anti-inflammatory effect was assessed by Carageenan induced rat paw edema, Cotton pellet induced granuloma in rats. Analgesic effect was assessed by Hot plate method and Acetic acid induced writhing method in mice. Results : In Carageenan induced rat paw edema, maximum inhibition by Ocimum sanctum, Aspirin and Celecoxib were 13.43%, 30% and 32% respectively and time to reach maximum inhibition for Ocimum sanctum was 2 hours. In Cotton pellet induced granuloma, percentage inhibition by Ocimum sanctum, Aspirin and Celecoxib were 23.85%, 45.84% and 42.77% respectively. In Hot plate method, maximum inhibition by Ocimum sanctum, Aspirin and Celecoxib were 143.92%, 288.18% and 260.59% respectively. In Acetic acid induced writhing method , percentage protection by Ocimum sanctum, Aspirin and Celecoxib were 50.2%, 71.4% and 66.5% respectively. Conclusion : The current study demonstrates statistically significant anti-inflammatory and analgesic activity of Ocimum sanctum.

IND-9

An in-vitro comparative study of the antibacterial activity of ethanolic extracts of Vitex negundo, Fragaria vesca, Terminalia arjuna and Citrus maximus on Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa

Borah M. , Das S.

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

Objective : To study and compare the antibacterial activity of the ethanolic extracts of Vitex negundo (EEVN), Fragaria vesca (EEFV), Terminalia arjuna (EETA) and Citrus maximus (EECM) on Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa by disc diffusion method. Materials and Methods : The ethanolic plant extracts were prepared from the bark of Terminalia arjuna and leaves of Fragaria vesca, Vitex negundo and Citrus maximus by percolation method. Clinical isolates of Staphylococcus aureus, E.coli and Pseudomonas aeruginosa were obtained from the Department of Microbiology, AMCH. Disc diffusion method for antimicrobial susceptibility testing was performed according to the standard Kirby Beur method. The whatman-1 filter paper discs of 6mm sizes impregnated with the plant extracts of 500mg/ml and 1g/ml were placed on Mueller-Hinton agar plates seeded with bacterial cultures of 0.5 Mc Farland standard. Ciprofloxacin(5μg/disc) was used as positive control. The antibacterial activities were assessed by the presence or absence of inhibition zones after incubating the plates at 37 0 C for 18 to 24 hours. Results : The plant extracts of EEVN, EEFV and EETA showed zones of inhibition(11-18mm) for Staphylococcus aureus and E.coli.EEFV also showed activity against Pseudomonas aeruginosa. EECM showed zones of inhibition (13-16mm) for E.coli and also for Pseudomonas aeruginosa that was resistant to the positive control (Ciprofloxacin). Staphylococcus aureus and E.coli were maximally inhibited by EEVN and EEFV respectively. The data were statistically analysed using ANOVA followed by Dunnett's multiple comparison tests and found significant. Conclusion : The study reveals the comparative antibacterial efficacy of the plant extracts. Citrus maximus may be a good candidate for further antimicrobial evaluation as sufficient study regarding it is lacking.

IND-10

Antidepressant activity of ethanolic extract of piper betel leavesin mice

Vinayak Meti , Ruckmani A., Chandrasekhar K., Venu Gopala Rao Konda, Eerike Madhavi, Swati. B.

Department of Pharmacology, Chettinad Hospitals and Research Institute, Chettinad University, Chennai - 603 103, Tamil Nadu, India.

Objective : To evaluate the antidepressant activity of ethanolic extract of Piper betel leaves in mice. Materials and Methods : 48 adult albino mice (swiss strain) weighing 25-30 grams were selected. 24 animals were allocated to forced swim test (FST) and 24 to tail suspension test (TST) models. In each model there were 4 groups. The control group received vehicle (10 ml/kg, p.o). The Standard, Imipramine (10mg/kg, p.o) and the two test groups received ethanolic extract of P.betel leaves (PBL)100 mg/kg, 200 mg/kg p.o. respectively, 1hour prior to the acute study. In chronic study the drugs were given orally once a day for 10 days and the last dose was given 1hour before the experiment. Duration of immobility was noted in FST and TST. Statistical analysis was performed using Mean ± SEM. ANOVA followed by Dunnet's test. P < 0.05 was considered statistically significant. Results : Ethanolic extract of PBL produced significant antidepressant effect at both the doses (100, 200 mg/kg), as indicated by reduction in immobility time compared to the control. The antidepressant effect was higher at 100 mg than at 200 mg. In addition the effect at 100 mg was greater than that for Imipramine. Conclusion : Ethanolic extract of PBL has shown significant antidepressant activity greater than Imipramine in mice. Keywords: Forced swim test, Tail suspension test, PBL, Depression.

IND-11

Wound healing activity of calendula officinalis linn: an appraisal

Anuradha A. Nadkarni , Subhash C. Marihal

P.E.S. Rajaram and Tarabai Bandekar College of Pharmacy Education and Research, Farmagudi, Ponda, Goa, India.

Objectives : To investigate the comparative wound-healing potency of aqueous and ethanol extracts of flowers of Calendula officinalis Linn. Materials and Methods: Excision, incision and dead space wound models were used to evaluate the wound-healing activity of Calendula Officinalis Linn., on Swiss Wistar strain rats of either sex. In excision wound model, treatment was continued till the complete healing of the wound, in incision and dead space wound models the treatment was continued for 10 days. For topical application, 5% w/w ointment of aqueous and ethanol flower extracts was prepared in 2% sodium alginate and for oral administration suspensions containing 30 mg/ml of each of the extracts in 1% gum tragacanth were prepared. In excision and incision wound models, the control group of animals were left untreated and in dead space wound models the animals were treated with 1 ml of 1% gum tragacanth / kg, b.w. The healing of the wound was assessed by the rate of wound contraction, period of epithelialisation, skin breaking strength, granulation strength, dry granulation tissue weight, hydroxyproline estimation and histopathology of the granulation tissue. Results : Aqueous and Ethanol flower extracts promoted the wound-healing activity significantly in all the wound models studied. High rate of wound contraction, decrease in the period for epithelialisation, high skin breaking strength and granulation strength, increase in dry granulation tissue weight, elevated hydroxyproline content and increased collagenation in histopathological section were observed in animals treated with ethanol leaf extract and aqueous leaf extract when compared to the control group of animals.

Conclusion : Ethanol and aqueous flower extracts of Calendula Officinalis Linn promote wound-healing activity. Ethanol extract possesses better wound-healing property than the aqueous extract.

IND-12
"Protective effect of citrus limon l. (burm) peels in Streptozotocin induced diabetic rats"


Bairagi G.B., Mandade R.J., * Randhe S.V. , Wawge D.D.

Sudhakarrao Naik Institute of Pharmacy, Pusad, Dist-Yavatmal, Maharashtra - 445 204, India. *E-mail: svrandhe09@gmail.com

Objective: To investigate protective effect of citrus limon L. (Burm) in streptozotocin induced diabetic rats. Materials and Methods: All the animals divided into five groups. First group treated as control received vehicle only. Remaining animals after 10 days of streptozotocin induction (60mg/kg/i.p) were divided into, second group as a diabetic control, third and fourth group treated with lower dose (250mg/kg/p.o.), higher dose (500mg/kg/p.o.) of ethanolic extract respectively. The fifth group treated with standard glibencamide (10mg/kg/p.o). The treatment given for the period of 8 weeks and blood sample was collected on 1 st , 4 th and 8 th week of the study. The various parameters like plasma glucose level, lipid profile, haematobiochemical such as Creatinine, total protein, urea, uric acid was estimated and compared for statistical analysis. Histopathology was also carried out for complete investigation. Result: After administration of higher and lower dose of extract for the period of 8 weeks shows the significant decreased in the plasma glucose level, serum Creatinine level, lipid profile, urea, uric acid level and increased in serum total protein. Histopathological study shows recovery of the injurious cells compared to the STZ-induced diabetic groups. Conclusion: The study able to demonstrate antidiabetic, antihyperlipdemic and cardio protective potential as well as nephroprotective activity. So, we can conclude that extract of Citrus limonL. (Burm) peels shows protective effect in diabetic complications in STZ- induced diabetic rats.

IND-13

Cystone, an Ayurvedic Formulation Improves Renal Function in Rats with Acute Renal failure -induced by Glycerol intoxication

Rajesh S. , Uday Kumar V.K., Vishwanath G.L., Rangesh P., Patki P.S., *Mohamed Rafiq

Department of Pharmacology, R and D Centre, The Himalaya Drug Company, Makali, Bangalore, Karnataka, India.

*E-mail: dr.rafiq@himalayahealthcare.com

Objective : The objective of the present study is to evaluate the beneficial effect of Cystone syrup on renal dysfunction in an experimental model of acute renal failure (ARF) in rats- induced by glycerol-intoxication. Materials and Methods : Forty male wistar rats were divided in to four groups of ten each. Rats from Group I and II received DM water (10ml/kg.p.o) and served as normal and positive untreated control respectively. Rats from Group III and IV received Cystone syrup at the dose of 2.5 and 5 ml/kgp.o. respectively. After one week of the assigned treatment, all the animals received a single intramuscular injection of glycerol (50% v/v) 8 ml/kg except group I rats, which were injected with normal saline 8 ml/kg.i.m. 24-hours after the injection, urine samples were collected and the rats were sacrificed after 48 hrs. Blood and renal tissue samples were collected for biochemical and histological examinations. Also, studies were carriedout to study the radical scavenging and inhibitory effect of Cystone on lipid peroxidation in vitro. Results: Glycerol administration caused severe renal dysfunction which was indicated by significant increase in markers of renal dysfunction such as serum creatinine, blood urea nitrogen (BUN), decrease in the Creatinine clearance (Ccr) and histopathological changes etc. Pre-treatment with Cystone syrup at the dose of 2.5 and 5 ml/kg dose dependendly protects the kidney against the changes induced by glycerol intoxication by decreasing serum creatinine (P<0.05), BUN (P<0.01)

IND-14

Investigation of in vitro and in vivo antimutagenic potential of tinospora cordifolia

Pankaj Tripathi , Pranav Dudhat

S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, India.

The present study investigated the antimutagenic effect of aqueous extract of Tinospora cordifolia (TC). In vitro Ames test, in vivo mouse bone marrow chromosomal aberrations (CA) assay and single cell gel electrophoresis (comet) were employed to measure the genotoxicity and DNA damage, respectively. The activities of hepatic markers of oxidative stress were also determined in vivo. Salmonella typhimurium strains TA 98 and TA 1535 were applied as the tester strains. Sodium azide (NaN3) was used as mutagen for ames test without metabolic activation. TC was tested for wide concentration range (100-5000 μg/plate) in triplicate. For CA and comet assay, animals were administered two doses of TC 150 and 250 mg/kg for 2 weeks prior to induction of clastogenicity by Cyclophosphamide. The results of ames test show that TC reduce the number of revertant colonies against the mutagenicity induced by NaN3. Cyclophosphamide significantly increased the chromosomal aberrations and induced DNA damage in mouse bone marrow cells, and also markedly inhibited the activities of hepatic SOD, CAT and GSH, while increased the MDA content. Pretreatments with TC significantly inhibited the frequencies of chromosomal aberrations; DN Adamage and also antagonized the oxidative stress in liver. The antimutagenic activity of TC could be due to its antioxidant activity. In conclusion, TC had significant antimutagenic potential in both in vitro and in vivo test systems.

IND-15

Antiarthritic activity of alcoholic and water extract of ayurvedic formulation catpusphadya churna by freund's adjuvant induced arthritis rats model

Hardik P. Patel , Nimisha D. Darji, Rakesh K. Patel

S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, India.

Objective : The aim of study was to evaluate the anti-arthritic activity of the water and alcoholic extract of Ayurvedic formulation Catpusphadya churna which contains (Piper nigrum, Anethum sowa, Embelia ribes, Saindhav salt). Catpusphadhya Churna is one of the classical Ayurvedic dosage form mentioned in book of "The Ayurvedic System of Indian Medicine", by Kaviraj Nagendranath Sen Gupta for treatment of body pain. Materials and Methods : The anti-arthritic activity of catpusphdya churna were carried out by freund's adjuvant induced rats arthritis model after approval of Institutional Animal Ethical Committee. Water and Alcoholic extracts of Catpusphadya churna 100 mg/kg and 200 mg/kg, 1% Carboxymethyl cellulose was used as vehicle control, dexamethasone 1 mg/kg positive control given orally to rat. Anti-arthritic activity was evaluated by determining physical parameters (body weight, inflammation, mobility test, Gait test, Joint stiffness, joint hyperalgesia), hematological parameters (red blood cells (RBC), white blood cells (WBC) and haemoglobin), and biochamical parameters (erythrocyte sedimentation rate (ESR) and RA factor). Results and Discussion: Results of anti arthritic activity of alcoholic and water extract of catpusphadya churna were significant as compared to vehicle treated control groups. Significantly decrement of inflammation of rat paw volume (P<0.05 to P<0.01), Gait score (P<0.05), WBC (P<0.05 to P<0.01), rheumatoid arthritis (RA) factor (P<0.05 to P<0.001), and erythrocyte sedimentation rate (ESR), significantly improvement of mobility (P<0.05 to P<0.01), RBC (P<0.05 to P<0.01), and hemoglobin (P<0.05 to P<0.01), significantly in treated groups from 0 to 28 days. Both alcoholic and water extract of catpusphadya churna shows significant anti inflammatory activity. Conclusions : Catpusphadya churna contain piperine, embelin and carvone phytoconstituents in their plant raw materials. These constituents may be responsible for significant anti arthritic activity.


  Mis Top


MIS-1

Analysis of information provided in drug package inserts in India

Pramod Pujari

Department of Pharmacology, Topiwala National Medical College and B. Y. L. Nair Ch. Hospital, Mumbai - 400008, India.

E-mail: pramodpujari7@gmail.com

Background : Access to clinically relevant, recent, reliable and unbiased information is an essential requirement of the physicians for rational drug use. Pharmaceutical companies disseminate information regarding marketed products through promotional materials, scientific meetings, and Package inserts which accompany drugs. Study was planned to analyse information provided in drug package inserts. Objective: To evaluate adequacy of format and completeness of the information in package inserts of drugs marketed in India. Materials and Methods: Package inserts accompanying allopathic drugs marketed in India were collected from four pharmacies. Information included in leaflets was analyzed according to headings in 'Section 6.2' of Schedule D, 1945 Act. Results: On analysing 153 package inserts only 38.56% were in appropriate format as described in regulations. Drug interactions were not mentioned in 33.98% of inserts. Adverse drug reactions were categorized only in 39 (25.49%) of the inserts. Date of update of information was mentioned only in 21 package inserts. Pharmaceutical section was incomplete in majority of leaflets. Discussion and Conclusion: Information for safe and effective use of drugs is missing in package inserts analysed. Regulatory authorities and Pharmaceutical companies should implement measures to provide accurate and recent information in drug package inserts which will reduce serious ADRs and drug related hospitalization

MIS-2

Evaluation of psychomotor performance of 2 nd MBBS students after exposing them to lectures during pre and post lunch session

*M.S.M. Bashir , Ajay Khade

Department of Pharmacology, Rajiv Gandhi Institute of Medical Sciences (RIMS), Adilabad, Andhra Pradesh - 504 001, India. *E-mail: drmsmbashir76@rediffmail.com

Objectives: In India, didactic lectures are important part of medical education. It is said that concentration levels never remain same during entire one hour lecture leading to impairment in cognitive performance. Moreover, status of performance in students might be different at different hours of the day. Therefore, we planned this study to evaluate the effectiveness of lectures at various time intervals by assessing the status of psychomotor performance. Materials and Methods: Twenty 2 nd MBBS students of RIMS Adilabad were included in the study. Psychomotor performance was evaluated using Digit Symbol Substitution Test (DSST) and Six Digit Cancellation Test (SDCT). Subjective assessment was done using Visual Analogue Scales (VASs). Tests were carried out before and after exposing the volunteers to lectures of 8 A.M. to 9 A.M., 1 P.M. to 2 P.M. and 3 P.M to 4 P.M. Results: Significant (p >0.05) impairment in the performance of DSST and SDCT were observed when 8 to 9 theory class was compared with 3 to 4. Post 3 to 4 lecture performance was significantly improved (p >0.05) in both the tests. The performance was nonsignificant on all the three VASs. Conclusion: Psychomotor performance of 2 nd MBBS students in our set up is better during the post lunch theory classes. Whenever teaching activities are planned local factors must be considered and optimum learning atmosphere should be provided to the students.

MIS-3

Analysis of students' assessment of different teaching methods in pharmacology.

Suneel Ishwar Majagi

Department of Pharmacology, K.L.E University's J.N.M.C, Belgaum, India. E-mail: suneelmajagi@yahoo.co.in

Objectives: Literature survey urges the need to reform pharmacology teaching. As a first step, students' attitude has been considered. This study has been conducted to analyse students' assessment of various teaching methods. Materials and Methods: Sample size was 126, consisting IIPhase M.B.B.S. students. Students' assessment of retaining, recalling and reproducing skills of different teaching methods were analysed by using different questionnaires with 5 point scale. A total of 17 teaching methods, 6 tests, 9 practical exercises and 20 learning characters were analysed. Inclusions of topics like use of animals, newer methods like e-learning, mobile teachings were also analysed. [Nonparametric tests and P<0.05 = significant]. Results and Conclusions: Present study findings indicate that some of the teaching methods significantly(P<0.05, P<0.01 and P<0.001) help "to" learn the following topics more effectively (method to topics) viz., Theory class teaching to History of drugs, Herbal medicines, Pathophysiology, Classification of drugs, Pharmacological actions, Adverse Drug Reactions, Selecting the drug and Understanding(whole subject); Sessional examinations(long/short essays) to Understand and Retention (whole subject), Pharmacological actions and Pass final examination; Practicals to Selecting dose and route of drugs and Pass final examination; Therapeutic problem to Clinical applications; Spotters to Retention; Tutorials to Pharmacological actions; Bedside clinical postings to Pathophysiology, Adverse Drug Reactions, Resistance against Antimicrobial-agents, Selecting the drug, dose and route, Multidrug prescribing and Retention (whole subject);Use of animals to Retention. Chalk-piece teaching was preferred to power-point teaching. Students expressed the need to keep in touch with their teachers on mobile for long time learning.

MIS-4

To study knowledge, attitude and pattern of use of over-the-counter drugs amongst undergraduate students of Subharti Medical College, Meerut (UP)

Surabhi Gupta , Meenakshi Jindal

Department of Pharmacology, Subharti Medical College, Delhi-Haridwar Byepass Road, Meerut, Uttar Pradesh - 250 005, India.

Objectives: Self medication is a very common practice among Indian population. It is directly related to the level of education. We wanted to ascertain the level of knowledge, source of knowledge and commonly favored categories of OTC drugs amongst medical undergraduate students as they are future health providers of society. Materials and Methods: The study was conducted on questionnaire based survey. Results : 65% of students possessed good knowledge about OTC drugs with parents / relatives being major source of information (60%). The most favored category of OTC medicines were of NSAID group (47%), followed by antimicrobials (16%), H1 antihistaminics (11%), Cough syrups (7%), antispasmodic (6%), drugs for hyperacidity (5%) multivitamins (4%). In NSAIDs, Paracetamol was most commonly self-prescribed drug for headaches and fever. Conclusions: Use of OTC drugs is highly prevalent in medical undergraduate students. NSAIDs are most favored category.

MIS-5

Are drug advertisements misleading us?

Shaveta Kaushal , Jatinder Singh, Jaswant Rai

Department of Pharmacology, Government Medical College, Amritsar, Punjab - 143 001, India.

Objectives: To determine the quality of drug advertisements for completeness, consistency, accuracy and validity using WHO's ethical criteria for drug promotion. To audit the drug promotional claims and pictorial data. To assess the accessibility and usefulness of drug promotional methods to the physicians, and their opinion about the information provided therein. Materials and Methods: In this observational, cross-sectional study, 100 drug advertisement brochures were collected, examined using WHO criteria and audited for claims, references and pictorial data. Questionnaires filled by 100 doctors were analyzed to find their opinions regarding accuracy and reliability of advertisements and whether they influence prescribing. Results: None of the advertisements fulfilled all the 15 WHO criteria. Only 5% and 13% advertisements matched 13 and 12 criteria respectively. 88% gave exaggerated claims, 80% efficacy claims and only 42% claimed safety. Vague pictorial data was provided in 70%, but brief prescribing information (BPI) only in 9%. 59% provided references, out of which 92% were from journals. 70% of doctors considered drug advertisements as biased still, 61% of them were influenced by them while prescribing and 41% were concerned about the safety profile. Conclusions: The study reflects that the majority of drug advertisements provide an information that is incomplete, inaccurate, exaggerated and devoid of safe prescribing information. Doctors are aware of the missing data, but not of the inaccuracy and unreliability of the data presented. There is an urgent need for active monitoring and enforcement rules so that the drug advertisements are more educational than promotional and contribute to rational prescribing.

MIS-6

Role of desferoxamine as an antioxidant in prevention of ischemic myocardial injury in rabbits

Gupta Ambrish , Jain I.P., Sharma M.K., Puri J.N., Agarwal Asha, Sharma Varun

Department of Pharmacology, GSVM Medical College, Kanpur, India.

Objective: Myocardial ischaemia and infarction are responsible for great number of deaths. Recent evidence suggest that damage caused by free radicals is also a contributing factor in ischaemic injury especially after reperfusion. This study was conducted with the objective of evaluating the role of desferoxamine, as an antioxidant in preventing ischaemic myocardial injury in rabbits. Materials and Methods: For this study rabbits were divided into 4 groups (n=5 in each group): control and test for pre-reperfusion desferoxamine therapy; control and test for post reperfusion desferoxamine therapy. To produce experimental myocardial ishaemia anterior descending branch of left coronary artery ligated with slip ligature, so whenever desired the reperfusion can be done. In this study the percentage mortality, heart rate, systolic and diastolic blood pressure, ST-segment elevation in ECG and as histopathological parameters infarct size and area at risk in percentage were observed before and after reperfusion of myocardium. Results: Pre-reperfusion desferoxamine test group showed decreased mortality in test animals (C=80%, T=40%) but not significant (P>0.05). Post reperfusion desferoxamine has no role in decreasing mortality. Hemodynamic parameters BP and HR showed no significant change in pre and post reperfusion (both) groups. Pre-reperfusion desferoxamine test groups showed significant (P<0.05) attenuation of ST-segment elevation but not in post reperfusion groups. Desferoxamine in pre-reperfusion test group decreased the infarct size significantly but not in post reperfusion one. Conclusion: These findings concluded that par-enteral (IV) administration of desferoxamine just before reperfusion can prevent oxidative free radical mediated reperfusion injury by limiting lipid-peroxidation but not effective in myocardial protection if administered after the reperfusion , when oxy-free radical cascade already sets in.

MIS-7

A trial of the objective structured practical examination in pharmacology at a rural tertiary care medical college - students point of view

Rushikesh Deshpande , Vijay Motghare, Sudhir Padwal, Chetanraj Bhamare, Rakesh Pore, Suvarna Rathod

Department of Pharmacology, Swami Ramanand Teerth Rural Medical College, Ambajogai, Dist. Beed, Maharashtra - 431 517, India.

Objectives: 1) To evaluate the attitudes of undergraduate medical students towards objectively structured practical examination (OSPE) component of Pharmacology practical examination. 2) To investigate any gender differences and any influence of medium of instruction in school on these attitudes. Materials and Methods: The score of 40 undergraduate medical students was analysed at S R T R Government Medical College, Ambajogai, Maharashtra. A Likert scale containing 9 items was used to assess the attitudes of students towards OSPE in Pharmacology. Student perspectives regarding the OSPE were obtained by asking them to respond to a questionnaire. Results: The study revealed that the OSPE was an acceptable tool in Pharmacology practical examination. The overall mean attitude score (3.99) was towards the favourable side. Male students showed more positive response than female students. Students strongly agreed that OPSE covers wide range of skills and it was a good form of examination and learning experience. Majority of students were in favour of continuing OSPE as method for examination in Pharmacology. Conclusions: OSPE was found to be a valuable tool to check the depth of understanding of undergraduate students. OSPE can be used as an index of the learning attitude of students throughout the year. The present study is a small step in a direction of changing the traditional patterns of practical examination to a more objective and reliable way of evaluation in Pharmacology. It will help in modifying teaching-learning strategies so that both, the teachers as well as the students can gain maximum advantage.

MIS-8

A study on awareness and attitudes of clinicians and post graduates regarding reporting of adverse drug reaction in a tertiary care hospital attached to a Medical College

Sudhakar K. , Ushakiran P., Sudha J., Vijay T., Srinivas A., Suresh N.

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

Objectives: To study and compare the attitudes and awareness of ADR reporting among clinicians and postgraduates (PGs) in Andhra medical college. Materials and Methods: An observational study was conducted with the help of a questionnaire to assess the awareness of ADR reporting, reasons for underreporting and suggested methods for improving ADR reporting among a sample of 118 containing 57 Clinicians and 61 Post graduate students. Results: 31% of the clinicians and 29% of the PGs are aware of ADR reporting system. Only 4.9% PGs as compared to 21% clinicians identified correctly the regional Pharmacovigilance Centre for Andhra Pradesh. 52% of clinicians and 34.4% PGs encountered a potential ADR within the last 12 months. But, only 17.5% clinicians and 4.9% PGSs reported an ADR during the same period. 95% of clinicians and 100% of PGs felt, lack of awareness of channels for reporting as the major cause for under reporting. 89% of clinicians and 100% of PGs felt that there should be CMEs regarding ADR reporting from under graduation. 100% clinicians and 85% PGs felt that every medical college should be a Peripheral Pharmacovigilance Centre. Conclusion: Only a few clinicians and PGs are aware of ADR reporting system and very few reported ADR's encountered by them. There is no major difference in the response of Clinicians and PGs regarding ADR reporting system and most of them felt lack of awareness of proper channel as the most important cause of under reporting.

MIS-9

Study on usage of self medication in mbbs0 students in a teaching hospital

Sireesha N. , Sudha J., Ushakiran P., Vijay T., Sudhakar K.

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

Objective: To assess the self-medication practices, the common types of illnesses for which self-medication has been taken among medical undergraduate students and to identify frequently used drugs, determinants of self-medication, drug information resources, the side effects encountered and attitude towards self-medication. Materials and Methods: An observational study with the help of a questionnaire (mentioning different groups of drugs) among the medical undergraduates. The collected data is represented in Excel 2007 for analysis and percentage calculation. Results: 95% of the students (n=156) used self-medication for their symptoms in the last 6 months. Prior experience (77%) and non seriousness of illness (44%) were the two major reasons of self-medication. The major source of information for most of those who practiced self-medication was from physician's prescription provided during their prior illness (40%) and advice from seniors/friends (33%). Paracetamol (20%) and antibiotics (18.8%) were the most commonly used drugs. Nausea/ vomiting (22%) and sedation (8%) were the common side effects encountered. Among the students 48% supported self-medication practice and 34% were against the practice. Conclusion: The study indicated the need for legal regulations regarding the sale of "prescription only drugs" even to medical faculty. The spectrum of "Over the counter" drugs should be narrowed (eg.Antibiotics should be excluded). Drug authorities should pose stringent rules against pharmacies marketing banned drugs (eg. Nimesulide). Students need to be educated about the long term adverse effects of the drugs and that indiscriminate use of antibiotics will result in uncontrolled rise in resistant pathogens, increases the morbidity and wastes the limited health care resources.

MIS-10

Study on the awareness of clinicians and post graduates about generic versus branded drugs in tertiary care hospital

Durgaprasad B. , Ushakiran P., Sudha J., Triveni M., Vijay T., Sudhakar K.

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

Objectives: To study the awareness of clinicians and post graduates (PGs) about generic versus branded drugs. Materials and Methods: An observational study of awareness of PGs and clinicians regarding generic compared to branded drugs with the help of a questionnaire (like are generics equivalent, cheaper compared to branded ones). The collected data is represented in Microsoft Excel 2007 for data analysis and percentage calculation. Results: 87% of PGs and 94% of clinicians are aware of Generic drugs. 65%, 85%, 100% and 98% of PGs and 44%, 63%, 94% and 94% of the Clinicians feel that Generic drugs are equivalent, safer, cheaper and reduce Pharmacoeconomic burden respectively. 87% of PGs and 100% of clinicians are aware of Jana Oushadi outlets. 91% of PGs and 75% clinicians support generic substitution .74%, of PGs and 94% of clinicians opine that emphasising the importance of Generic drugs in Undergraduate education. Conclusions: Majority of doctors are aware of generic drugs and consider generics are safe and cheaper and support generic substitution in most cases. But strict Quality control studies should be done to maintain efficacy and safety of generic drugs as only few of them feel that generics are therapeutically equivalent to branded drugs. Majority doctors support media publicity, Political commitment and increase in Jana Oushadi outlets to encourage Generic prescription. Generic prescription should be a part of undergraduate education to have an effect from grass root level.

MIS-11

Exposure to and attitudes about the pharmaceutical industry in postgraduate and undergraduate medical students in a Government Medical College

Bindra Harleen , Nim D.K., Misra P., Zia F., Goel Bhomik, Chaurasia R.C.

Department of Pharmacology, Motilal Nehru Medical College, Allahabad, Uttar Pradesh, India.

Objective: To assess the exposure and attitudes of postgraduate and undergraduate medical students about the pharmaceutical industry. Materials and Methods: A questionnaire was prepared which had 26 questions, the answers to which were to be given as yes or no. It was randomly distributed to 80 postgraduate (PG's) and 70 undergraduate (UG's) medical students of Allahabad Medical College, out of which 63 PG's and 66 UG's returned the completed questionnaires which were then analyzed. The questions were framed regarding the exposure of the students to the pharmaceutical industry, for e.g. had they attended any educational presentations, had they received any gifts from pharmaceutical sales representatives (PSR's) or did they feel adequately educated about interactions with the industry. Some questions were regarding students' attitudes about the industry, for e.g. did they consider the PSR's or educational presentations to be biased or did the gifts influence prescribing. Results: The results were assessed and compared for both the PG's and UG's. Some questions had a similar response from both the groups, while for a few there was a substantial difference of opinion. For e.g. where 83% PG's had attended the educational presentations, only 30% of the UG's had done so. 53% PG's and 60% UG's thought that the drug samples were not being rightly utilized. 80% PG's and 60% UG's supported industry sponsored events in curriculum. About 53% PG's felt adequately educated about the industry, while only 21% UG's felt the same. Conclusion: For quality patient care, a symbiosis has to exist between the clinicians and the pharmaceutical industry. The study points towards the dearth of knowledge in PG's as well as UG's regarding clinical trials and industrial role in patient care. Thus keeping in mind that medical education modifies the thought process of the students, some aspects of industrial interaction should become a part of UG curriculum.

MIS-12

A pilot survey to evaluate the knowledge, attitude and practice of pharmacovigilance among medical practitioners in Kolhapur city, Maharashtra

Patil Sunita S. , Khanwelkar Chitra C. 1 , Phirke Vivek R. 2

Department of Pharmacology, D.Y. Patil Medical College, Kolhapur, 1 Department of Pharmacology, Krishna Institute of Medical Sciences, Karad, 2 Maharash Emcure Pharmaceutical Ltd., India.

Objectives: National Pharmacovigilance program is recently launched in India. Major problem is under-reporting of ADRs. This study was aimed at investigating the knowledge and attitudes of doctors towards ADR reporting in a teaching hospital, practicing doctors and third year MBBS students. Materials and Methods: The survey questionnaire were distributed to three groups i.e. Group 1(n=36) includes clinicians and post graduates working in medical college, Group 2(n=30) includes private practitioners and Group 3(n=40) includes III rd year MBBS students. The questionnaires were structured to obtain information about the knowledge and awareness of Pharmacovigilance, attitude and factors influencing this attitude. Results: 83.3% institutional clinicians, 86.6% private practitioners and 80% students were aware of Pharmacovigilance and ADR monitoring system. ADR reporting was practiced by 0% institutional and 13.3% private practioners. 75% students said they were sufficiently made aware about ADR reporting. 83.4% institutional doctors, 70% private practitioners and 75% students were not aware of spontaneous reporting.72.2% institutional doctors, 56.6% private practitioners and 37.5% students said direct ADR reporting should not be allowed. All three groups said this system is going to benefit the patients and they wanted to know more about this system. Conclusion: There is dire need of creating awareness about Pharmacovigilance among practicing doctors. Awareness of this is more in III rd year MBBS students, might be a result of inclusion of this topic in undergraduate syllabus. The effective Pharmacovigilance in India is possible only if training of all health professionals is done effectively and made mandatory by MCI.

MIS-13

Critical evaluation of promotional drugliterature

Phirke V.R. , Khanwelkar C.C. 1 , Patil S.S. 2 , More K.E. 3 , Thorat V.M. 1 , Jadhav S.A. 1

Emcure Pharma.Ltd., 1 Department of Pharmacology, Krishna Institute of Medical Sciences Karad, 2 Department of Pharmacology, D.Y.Patil Medical College, Kolhapur, Maharashtra, 3 Department of Pharmacology, Travancore Medical College, Kollam, Kerala, India.

Objective: To have a control on inappropriate drug promotion, WHO has laid 'Ethical Criteria For Drug Promotion'. The objective of this study was to critically evaluate the 'Leave Behind' drug literatures, with respect to the ethical guidelines given by WHO and 'International Federation of Pharmaceutical Manufacturers Association'. Materials and Methods: 50 leave behind drug literatures each of cardiovascular, nervous system, antimicrobial and OTC drugs were evaluated. The parameters considered were brand name, generic name, ingredients, therapeutic uses, contraindications, interactions/precautions, adverse reactions, scientific references, name and address of manufacturer and date of production of literature. Literatures were scored by using a self-devised scoring system based on absence or presence of complete/incomplete information of each parameter (Maximum Score 17).Literatures were assessed for presence of appealing images, objectionable claims, improper graphs also. Results: The literatures failed to reveal dosage form / ingredients (30%), therapeutic uses (18%), name and address of manufacturer (12.5%), date of production of literature (72.5%). The literatures had mentioned therapeutic uses incompletely (65%), adverse reactions, interactions, pre cautions (7%). We found 302 appealing images, 144 objectionable claims and 27 inappropriate graphs in 200 literatures. 59% literatures obtained low score (1-7), 35% obtained medium score (8-12) and 6% obtained high score (13-17). Maximum low scoring literatures were of OTC group. Conclusion: There is substantial scope for improvement in the drug literatures given by pharmaceutical companies in India. Strict adherence to standard ethical guidelines may increase value of promotional literature as reliable source of information of drugs.


  Neu Top


NEU-1

Evaluation of effect of allopurinol in behavioural model of depression in mice


Karve Ashwini, Jagtiani Sagar Suresh

Department of Pharmacology, Topiwala National Medical College and B.Y.L. Nair Ch. Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai - 400 008, India.

Objective: To evaluate the effect of chronic administration (21 days) of Allopurinol on depression using Forced Swim Test in mice. Materials and Methods: Allopurinol in the dose of 39 mg/kg was administered once daily for 21 successive days to a group of Swiss Albino mice. On the 21 st day, one hour after administration of the drug, the effect of the drug on locomotion was tested using Photo-actometer followed by the recording of immobility period in the Forced Swim Test (FST). The antidepressant like effect of Allopurinol was compared to that of Fluoxetine (10mg/kg) administered for 21 successive days. Results were analysed using one way analysis of variance (ANOVA) followed by post-hoc Tukey's test. P value of <0.05 was considered significant. Results: Allopurinol expressed significant antidepressant like effect as indicated by reduction in the immobility period of mice in the FST as compared to control group without producing any effect on the locomotor activity of the animal. The effect of Allopurinol was found to be comparable to that of Fluoxetine. Conclusion: The results of the present study indicate that Allopurinol has significant anti-depressant action.

NEU-2

Evaluation of seizure modifying potential of Ondansetron in mice


P.R. Pandit, Nisha Jadhav , V.S. Chawan, M.S. Bhosale, P. Pujari

Department of Pharmacology, Topiwala National Medical College and B.Y.L. Nair Ch. Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai - 400 008, India.

Objective: To evaluate the seizure modifying potential of Ondansetron in experimental models of seizures in mice. Materials and Methods: Mice were treated with three different doses of ondansetron i.p., mainly 3mg/kg, 6mg/kg and 8mg/kg and control group received normal saline i.p.for 3days. On 3 rd day, mice were subjected to MES of different current strength i.e.subconvulsive and convulsive current strength half hr after ondansetron administration and findings were recored. The minimum threshold current at which tonic hind limb extension occurred was recorded. Each animal was observed for incidence and duration of tonic hind limb extension and the strength of current was noted. In PTZ model, mice were subjected to subconvulsive dose 45mg/kg and convulsive dose 60mg/kg. The incidence, onset of convulsion and dose of PTZ were recorded. Results: Mice receiving ondansetron 3mg/kg, showed significant decrease in duration of tonic hind limb extension at convulsive 50mA current strength (P< 0.001). While group receiving 6mg/kg, showed decrease in seizure threshold. (40mA current strength). Mice receiving 3mg/kg, showed significant increase in onset of seizures (P< 0.001) at convulsive 60mg/kg dose of PTZ. While mice receiving 6mg/kg, show decrease in seizure threshold. (subconvulsive PTZ dose 45mg/kg). Group receiving 8mg/kg ondansetron, show 100% mortality due to convulsions caused by ondansetron. Conclusion: Ondansetron at low therapeutic dose acts as anticonvulsive, while at high therapeutic dose, itacts as proconvulsant. Ondansetron causes convulsions at toxic dose. So, care should be taken while giving ondansetron in high doses to prevent chemotherapy induced emesis.

NEU-3

Evaluation of the seizure modifying potential of sildenafil in mice

Manisha Bhosale , Pandit, Mainkar, Munde, Bhete

Department of Pharmacology, Topiwala National Medical College and B.Y.L. Nair Ch. Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai - 400 008, India.

Objective: To evaluate the seizure modifying potential of various doses of Sildenafil in experimental models of mice. Materials and Methods: Mice were divided in 4 groups in both MES and PTZ model. Control group received normal saline i.p. Test group received single dose of sildenafil i.p (6.5, 13, 26 mg/kg) 30 min later mice in MES model were subjected to 50 mA strength of Maximal electroshock using a electroconvulsiometer and time duration for tonic limb flexion and extension, recovery/death was observed. Similarly in PTZ model mice were administered pentenyltetrazole i.p 80 mg/kg after administration sildenafil (6.5, 13, 26 mg/kg) 30 min prior to PTZ in test groups. Time interval between PTZ injection and occurrence of jerks, seizures, recovery /death was recorded. Results: In MES model, Mice receiving sildenafil 13 and 26 mg/kg, show significant increase in duration of tonic hind limb extension at 50mA current strength (P< 0.001), while there was no significant change at 6.5 mg/kg.In PTZ group, Mice receiving 26 mg/kg, show significant decrease in latency of onset of jerks (P< 0.01) and significant decrease in onset of seizure onset( P <0.05) at 80mg/kg dose of PTZ. Conclusion: Sildenafil is proconvulsant, when used at higher doses therapeutic doses so, over the counter use of sildenafil without medical advice should be restricted.

NEU-4

Comparative study of psychomotor performance in schizophrenia and depression patients with healthy volunteers

*Ajay Khade , M.S.M. Bashir

Department of Pharmacology, Rajiv Gandhi Institute of Medical Sciences (RIMS), Adilabad, Andhra Pradesh - 504 001, India. *E-mail: ajay_khade2000@yahoo.com

Objectives: The psychomotor performance in psychiatric diseases like schizophrenia and depression is usually impaired. With drug treatment the performance is supposed to be improved. Paper pencil tests are validated tool for assessment of psychomotor functions. Hence the present study was planned to compare psychomotor performance in schizophrenia and depression patients taking drug treatment with healthy volunteers. Materials and Methods: The study was conducted in Pharmacology and Psychiatry department of RIMS, Adilabad. A total of 32 patients (16 schizophrenia and 16 depression) taking drug treatment and 32 healthy volunteers were included. Patients taking drug treatment for not less than one month were included. Cognitive performance was evaluated by objective tests like Digit Symbol Substitution Test (DSST), Six Digit Cancellation Test (SDCT) and Arithmetic Ability Test (AA) and subjective assessment by Visual Analogue Scales (VAS1, 2, 3). Results: Psychomotor performance in DSST (P < 0.0001), SDCT (P = 0.0003) and AA test (P = 0.0012) was found to be significantly impaired in comparison to healthy volunteers. On subjective scales, performance on VAS-1 (P = 0.1911), VAS-2 (P = 0.2261) and VAS-3 (0.5956) was not significant in comparison to healthy volunteers. Conclusion: Psychomotor performance in schizophrenic and depression patients taking drug treatment is significantly impaired in comparison to healthy volunteers.

NEU-5

To evaluate the analgesic effect of duloxetine and its Interaction with morphine and naloxone in rats

*Ayesha Siddiquea , Ramabhimaiah, V. N. Biradar

Department of Pharmacology, Navodaya Medical College, Raichur - 584 103, Karnataka, India. *E-mail: ayeshasid6@gmail.com

Objective: To study the probable site of the anti-nociceptive action of duloxetine and its interaction with morphine and naloxone. Materials and Methods: The anti-nociceptive activity of duloxetine was studied using Tail flick method in the absence and presence of naloxone in rats. Morphine 1mg/kg, duloxetine 10mg/kg and naloxone 1mg/kg were administered to study their interaction on Tail flick latency. Results: A dose of 1mg/kg morphine produced a significant increase in Tail flick latency at 30 mins that persisted during the entire test period. Combination of duloxetine 10mg/kg and morphine 1mg/kg produced an additive effect. Naloxone pretreatment did not affect the anti- nociception produced by duloxetine. Conclusion: It is not yet known whether the analgesic action of SNRI (duloxetine) involves an interaction with opioid system similar to tricyclic antidepressants but the present study suggests that opioid system does not contribute to the effect of duloxetine.

NEU-6

Anti-epileptic effect of ethanolic extract of marsilea quadrifolia in rats

Mukunda N. , Avinash H., Chandrashekar B.R., Satish M.C., Adhikari S., Bairy K.L.

Department of Pharmacology, Kasturba Medical College, Manipal, India.

Objectives: To evaluate anti-epileptic activity of ethanolic extract of Marsilea quadrifolia (MQEE) in rats by using maximal electroshock (MES) and pentylenetetrazole (PTZ) induced seizure models. Materials and Methods: Male Wistar rats (n=48) weighing 250-300 g were divided into four groups (n=6) in each model; Group I- Control (Saline), Group II- Standard (Phenytoin 300 mg/kg in MES and Sodium Valproate 200 mg/kg in PTZ model), Group III- MQEE 400 mg/kg and Group IV- MQEE 600 mg/kg. After 60 min of oral administration of above mentioned agents, all animals in MES model received electricshock (150mA, 50Hz for 0.2 sec) and in PTZ model, PTZ (60 mg/kg i.p.) respectively. In MES model, occurrence of tonic hindlimb extension and in PTZ model, time to onset of first clonus and seizures were recorded. Analysis was done using one way ANOVA. Results: In MES model 50% of rats in Group III and IV were protected from developing hindlimb extension, when compared to Group I; while in Group II all the rats were protected. In PTZ model, time to onset of first clonus and seizures were significantly prolonged in Group IV (216.67 ± 64.58 and 467.0 ± 206.39 sec) when compared to Group I (58.0 ± 12.13 and 80.16 ± 21.48 sec) but not significant when compared to Group II (360.33 ± 136.20 and 1251.66 ± 208.07 sec). Conclusion: The ethanolic extract Marsilea quadrifolia is having significant anti-epileptic activity and its mechanism of anti-epileptic action is yet to be elucidated.

NEU-7

Protective effect of melatonin against oxidative stress

K. Karthika , Preetha Selva, V. Srinivasan, S. Seethalakshmi

Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Chennai - 600 116, India.

Introduction: N-acetyl-5-methoxytryptamine (Melatonin) is a hormone produced by pineal gland. Melatonin promotes spindle formation in the thalamus and acts as a sedative. It delays aging, enhances cytokine production by lymphocytes, decreases blood pressure and prevents cardiac arrhythmias. These effects are mediated through MT1 and MT2 receptors. Stress, acute or chronic, can lead to insomnia. During insomnia, there is liberation of free Radicals. So, we studied melatonin to assess whether it has free radical scavenging property. Objectives: 1.To study the effect of different doses of melatonin on free radical scavenging property 2.To compare the antioxidant property of minimal doses of melatonin with a standard antioxidant. Materials and Methods: We studied the antioxidant effect of melatonin using Lipid peroxidise inhibition assay (Reiter et al). Different concentrations of melatonin were studied. The results were compared with a standard antioxidant, curcumin. Results: Our study showed that 1.5 mcg/ml of melatonin led to 58.95% inhibition of lipid peroxidation. Lower and higher doses led to increased protection but intermediate doses led to a decrease in protection.When antioxidant properties of melatonin and curcumin were compared, melatonin was a better antioxidant at lower doses. Both were equally efficacious at intermediate doses.

Conclusion:
Our study showed that the free radical scavenging property of melatonin varied with different doses. Compared to curcumin, the percentage of protection against lipid peroxidation was higher with melatonin. The antioxidant activity of melatonin has a contributory role in the sedative property of melatonin.

NEU-8

Study of antiepileptic activity of flupirtine in albino mice

Naveen Kumar M. , Prashanth P., Prabhakar Adake, Gokul C.G., Abhishek Acharya, Shankar A.S.

Postgraduate Pharmacology, JJMMC Boys Hostel, MCC B Block, Davangere, Karnataka, India.

Objective: To evaluate anticonvulsant activity of flupirtine against maximum electroshock (MES) induced seizures in albino mice. Materials and Methods: In MES method 24 male albino mice weighing between 30 to 40 gm, were divided into 4 groups each containing 6 animals. Group I (Standard) received phenytoin sod 20mg/kg po. Flupirtine dissolved in Di Methyl Sulphoxide (DMSO). Group II (Test) received flupirtine 39mg/kg po. Group III (Test) received flupirtine 79mg/kg po. Group IV (Control) received DMSO 1ml/kg po. Convulsion was induced by stimulus of 45mA for 0.2sec by ear electrodes. The animals were observed closely for 2 min and duration of hind limb extension was recorded. Results: The results were analyzed by one way ANOVA followed by posthoc tukeys test. There was significant reduction of duration of hind limb extension in group III (flupirtine 79mg/kg) as compared to control group [DMSO] (p<0.005). But reduction in duration of hind limb extension was not significant in group II (flupirtine 39mg/kg) and group III(flupirtine 79mg/kg) as compared to group I(phenytoin20 mg/kg). Conclusion: In comparison with DMSO, Flupirtine at a dose of 79mg/kg po, has significant anticonvulsant activity.

NEU-9

Analgesic activity of chloroform leaf extract of ficus racemosa linn.

Niket Rai , R.P. Agrawal, Savita Vyas, P. Phadnis

Department of Pharmacology, M G M Medical College, Indore, Madhya Pradesh - 452 001, India.

Objective: To evaluate analgesic activity of chloroform leaf extract of Ficus racemosa and its comparison with standard drugs using acetic acid induced writhing and hot plate methods in mice. Materials and Methods: Chloroform leaf extract was obtained using soxhlet apparatus (FRE). Swiss albino mice of either sex, 23±2gms were used for experiments. Animals were divided into 6 groups (n=6). Analgesic activity of FRE was evaluated at the doses 50, 100 and 200 mg/kg per oral. Diclofenac sodium (5 mg/kg) and Pentazocine (5 mg/kg) were used as standard drugs for acetic acid induced writhing and hot plate method respectively. In hot plate method, the temperature was maintained at 55 0 C±1 0 C while 1% v/v acetic acid by i.p. was used to induce pain sensation in writhing model. Result: FRE at the dose of 50mg/kg did not shows any significant analgesic activity (P>0.05) while at the dose of 100 and 200 mg/kg it showed significant analgesic activity (P<0.001) as compare to control group in both the experiments. FRE, at the dose of 200mg/kg showed significant analgesic activity (P<0.05) as compare to diclofenac and pentazocine, in writhing method and in hot plate model respectively. However, in the combination study, FRE (50 mg/kg) with diclofenac or pentazocine produced highly significant analgesic activity (P<0.01) as compared to control value or either treatment alone. Conclusion: FRE endowed with both central and peripheral analgesic properties in dose dependent manner. And also enhances the analgesic effect of the standard drugs.

NEU-10

Comparative effectiveness study of vinpocetine vs Nimodipine on functional recovery in patients of head injury

Alok Singh , Vivek Sharma 1 , B.L. Pandey

Departments of Pharmacology and 1 Neurosurgery, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.

Objective: Head injuries are increasing cause of overall disability which needs aggressive researches on neuroprotective agents to prevent or rectify the sequelae of brain damage. Nimodipine is used for long in cases of hemorrhagic brain damage while other drug options have not been adequately substantiated on neuroprotective cases. Circulatory compromises due to edema, oxidant-excitotoxic damage make vinpocetine also an attractive option. The outcomes on functional recovery following add on therapies either nimodipine or vinpoceine was done to compare merits of either therapies. Materials and Methods: 45 head injury cases admitted to S.S. hospital were divided into standard treatment group givent neither vinpocetine nor nimodipine and other two groups given either nimodipine or vinpocetine dependent entirely on clinician's discretion. The patients data on initial severity on GCS scale and functional recovery on Barthel Index, head injury watch scale, Disability rating score were collected at discharge and at one month follow up thereafter to compare the recovery profiles. Result: Vinpocetine treatment proved superior to nomodipine or standard treatment on examining the outcomes by moods median analysis. Significance of time since injury was emphasized for improved outcome to nimodipine but not so necessary for vinpocetine. Vinpocetine doses used were suboptimal while nimodipine was given as per recommended doses. Conclusion: Nimodipine delayed administration had no consequence while vinpocetine is useful treatment at any stage to enhance functional recovery in cases of head injury.

NEU-11

Evaluation of anticonvulsant activity of magnesium oxide alone and along with topiramate and phenytoin against maximum electroshock induced seizures in albino rats.

Shankar A.S. , Somashekar H.S., Narendranath S., Suryanarayana Babushaw N., Naveen M., Raghuprasada M.S.

Department of Pharmacology, JJM Medical College, Davangere - 577 004, India.

Objective: To evaluate anticonvulsant activity of magnesium oxide alone and along with topiramate and phenytoin in albino rats. Materials and Methods : 48 healthy male albino rats weighing between 100-200gm were divided into 8 groups. Group A is control, Group B,C,D,E were given MgO 500mg/kg and group F was given MgO1000mg/kg for ten days. On 11 th day topiramate 9, 18, 36, 36mg/kg, and phenytoin36mg/kg was given orally to groups C, D,E,G and H respectively one hour before MES induced seizures to groups. Convulsion was induced by stimulus of 180mA for 0.2sec by ear electrodes. Abolition of Tonic hind limb reflex and time taken to regain righting reflex was noted for each animal. Results: The results were analyzed by one way ANOVA followed by posthoc turkey's test. There was significant increase in percentage of abolition of tonic hind limb extension(THE) and decrease in time taken to regain righting reflex in groups receiving only magnesium oxide in comparison to control group (P<0.005).There was dose dependent increase in percentage of abolition of THE and decrease in time taken to regain righting reflex in animals receiving low dose, intermediate and high dose topiramate along with magnesium oxide in comparison to high dose topiramate and high dose phenytoin which was statistically significant. Conclusion: Magnesium oxide has anticonvulsant activity and this activity may be due to blockade of NMDA receptor channels by magnesium ions. Intermediate and lowdose topiramate along with magnesium oxide supplementation is equally effective in comparision to high dose topiramate and phenytoin.

NEU-12

Evaluation of Anticonvulsant activity of Magnesium oxide alone and along with Carbamazepine

Navin A. Patil , Abhishek Acharya, Somashekhar H.S., Narendranath S., Suneel Kumar Reddy, Shankar A.S.

Care of SV Lokesh, Door no 3811, Sri Veerbhadreshwar Nilaya, 19 th main, 4 th cross, MCC B Block, Davangere - 577 004, Karnataka, India.

Objective: To evaluate anticonvulsant activity of Magnesium Oxide alone and along with Carbamazepine against maximum electroshock (MES) induced seizures in Albino Rats. Materials and Methods: In MES method, 36 male albino rats weighing between 100-200gm, were divided into 6 groups each containing 6 animals were all treated with magnesium oxide(500,1000mg/kg) for 10 days orally. On 11 th day Carbamazepine (50,30mg/Kg) was given orally an hour before MES induced seizures except control and only magnesium oxide groups. Abolition of tonic hind limb extention reflex and time taken to regain righting reflex were noted for each animal after MES induced seizures. Results: The results were analyzed by one way ANOVA test. There was significant increase in percentage of abolition of THLE and decrease in time taken to regain righting reflex in in groups receving only magnesium oxide in comparision to control group The group which receieved low dose carbamazepine along with magnesium oxide was effective as high dose carbamazepine alone. There was no significant decrease in percentage of abolition of THLE and time taken to regain righting reflex in animals receiving high dose carbamazepine along with magnesium oxide in comprision with high carbamazepine. P<0.005. Conclusion: Magnesium oxide has anticonvulsant activity. Low dose carbamazepine along with magnesium oxide supplementation is equally effective in comparision to high dose carbamazepine.

NEU-13

An observational study on incidence of nausea and vomiting with different brands of oral tramadol HCL


Somashekar, Sohit Anand, Gokul C.G. , Srinivas L.D., Kiran L.J., Murthy S.S.

Department of Pharmacology, JJMMC, Davangere, Karnataka, India.

Objectives: To observe for the incidence of nausea and vomiting with different brand products of oral tramadol. To compare the incidence and grading of nausea and vomiting among different brand products and its relation with the concentration of (+) and (-) isoforms. Materials and Methods: The patients attending orthopaedic out-patient departments who were prescribed different brand products of tramadol (Brand A and Brand B) were enrolled according to the order of enrollment such that every first patient received Brand A, second Brand B, so that equal number of patients were recruited in each of these groups. Totally 35 patients were recruited for Brand A and 36 for Brand B Group. The patients prescribed with different formulations of tramadol under these different brand names were observed for the incidence of nausea and vomiting. The grading of nausea and vomiting was done by Common Terminology Criteria for Adverse Events (CTCAE) Version 4. At the end of 3 months the data collected were analyzed using Mann-Whitney tests and the difference in the incidence or grading of nausea and vomiting among the different brand products were calculated. Results: Nausea: No statistically significant difference was observed between 2 groups with respect to the Nausea scores recorded on Day 1 (p>0.05), Day 2 (p>0.05), Day 3 (p>0.05), Day 4 (p>0.05), Day 5 (p>0.05). Vomiting: No statistically significant difference was observed between 2 groups with respect to the Vomiting scores recorded on Day 1 (p>0.05), Day 2 (p>0.05). No comparisons were carried out on day 3, day 4 and day 5 as no vomiting was recorded in patients who were administered either of the brands. Conclusion: Different products of tramadol (Brand A and Brand B) had incidence of nausea and vomiting. But they had no significant difference when compared to each other.

NEU-14

A randomized open label active control study comparing safety and efficacy of levetiracetam and oxcarbazepine as monotherapy in newly diagnosed partial onset seizures

Jacob Jesurun R.S. , Manimekalai K., Murugesan S.

Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute, Pondy-Cuddalore Main Road, Pillaiyarkuppam, Puducherry - 607 402, India.

Objectives: To compare the efficacy and tolerability of levetiracetam with that of oxcarbazepine as monotherapy in newly diagnosed partial onset seizures. Materials and Methods: Newly diagnosed partial seizure patients attending the neurology outpatient department in a tertiary care center were randomized into Oxacrbazepine and Leviteracetam group (30 patients each). These patients were followed up for a 6 week period of stabilization (with step wise increase in dose) and 26 weeks after stabilization for seizure control and adverse effects. Results: In Oxcarbazepine group, most of the patients (70%), achieved seizure freedom at 6 months with Dose level 1(150mg BD) itself. 2 patients(6.66%) achieved seizure freedom at Dose Level 2 (300mg BD) and 2 patients (6.66%) at Dose Level 3 (600mg BD). In 2 patients, seizures were not controlled inspite of maximum dose. These patients were started on alternative drugs.In Leviteracetam group also, most of the patients (63.33%) had seizure control at 6 months with Dose level 1 (250mg BD) itself. 5 patients (16.67%) had control on Dose Level 2 (500mg BD). 2 patients(6.67%) had seizure control at maximum Dose Level 3(1500mg BD). In1 patient, seizures were not controlled inspite of maximum dose. This patient was started on alternative drugs.In Oxcarbazepine group, 26 patients (86.66%) were seizure free, at the final evaluation at 26th week after 6 weeks of dose stabilization.In Leviteracetam group, 25 patients (83.33%) were seizure free at the final evaluation. Adverse effect profiles were comparable between the 2 groups. Only 1 patient in each group had to discontinue treatment owing to adverse drug reaction (cutaneous rashes). Conclusion: In this study, Leviteracetam has been proven non-inferior to Oxcarbazepine in treatment of new onset partial seizures, both in terms of efficacy and tolerability.

NEU-15

Experimental evaluation of tinospora cordifolia and bacopa monniera for learning and memory enhancement- a pilot study

Kiran P. Poojar , Pratibha Nadig, B.N. Srinivas, Lingaraj Jayalakshmi

Vydehi Institute of Medical Sciences and Research Centre, #82, EPIP Area, Nallurahalli, Whitefield, Bangalore - 560 066, India.

Objectives: To evaluate the efficacy of aqueous extract of Tinospora Cordifolia (TC) at the doses of 50mg/kg and 100 mg/kg and Bacoppa Monniera (BM) at the doses of 40 mg/kg and 80 mg/kg on learning and memory using Hebbs Williams maze (HWM), Passive avoidance apparatus paradigm (PAT), Spatial habituation learning (SHL). Materials and Methods: 30 Wistar albino rats were randomized into 6 groups-two for BM, two for TC, one for Piracetam(400mg/kg i.p) and another for control. Learning trial was conducted seven days after dosing. Step through latency (STL), time to reach reward chamber (TRC) and no of crossings (CR) and no of rearing's (RR) in PAT, HWM and SLP respectively. Retention trial was conducted in all the groups after 24 hours, same outcomes were recorded. The mean decrease in TRC in HMW; mean increase in STL in PAT and mean decrease in the number of crossings and rearing's in SLP were analyzed between the groups using ANOVA. P≤0.05 was considered statistically significant. Results: In comparison with the normal control, Piracetam showed significant improvement in PAT and SLP, BM at 40 mg/kg showed significant improvement in all the three models; BM at 80mg/kg showed improvement in PAT only. TC was found to be effective at 50mg/kg in PAT model but 100mg/kg did not produce significant improvement in any of the models. Conclusion: Bacoppa Monniera at a dose of 40mg/kg and Tinospora Cordifolia at the dose of 50mg/kg, orally for seven days is effective in improvement of learning and memory. However the study needs further confirmation using larger no of animals.

NEU-16

A comparative study of venlafaxine and milnacipran in major depression

Vidushi Sharma , Shailesh Yadav, Moushumi Purkayastha, Rani Walia

Department of Pharmacology, Maharishi Markandeshwar Institute of Medical Sciences and Research (MMIMSR), Mullana, Ambala, India.

Objective
: To compare the efficacy and safety of venlafaxine and milnacipran in major depression. Materials and Methods : A 8 weeks prospective, randomized, open, parallel group study was conducted in patients meeting the DSM-IV-TR criteria for MDD and fulfilling the inclusion and exclusion criteria. Patients were divided randomly into Group A (n=30; Tab. Milnacipran 50-150 mg/day/po) and Group B (n=30; Tab. Venlafaxine 50-150 mg/day/po). Vital signs, MADRS, HDRS and CGI Scales and any adverse-effects were recorded at weeks 0, 1, 2, 4, 6, 8. Patients were labeled as: Responders- at 50% reduction in baseline HDRS and MADRS Scores and as Remission- when HDRS scores reduced to ≤7 MADRS ≤ 12 on drug treatment. Results : The mean baseline HDRS, MADRS and CGI in group A patients was 27.23±3.20 , 34.17±5.45 and 5.03±0.76 respectively and 28.23±4.47, 34.13±4.7 and 5.10±0.71 respectively in group B. On starting the treatment, patients in both the groups showed decline in the score which was statistically significant (P<0.001) compared to the baseline values, while inter-group comparisons were non significant (P>0.05). Responses and remissions were higher in Group B but statistically not significant (P>0.05). Common adverse events were: nausea, dizziness, headache and, in males, genito-urinary problems. Hemodynamic parameters showed a statistically significant effect on both systolic and diastolic blood pressure in group B, which showed an increase in SBP and DBP (P<0.05; P<0.001) as compared to Group A (P<0.05). Conclusion : The overall efficacy and safety of venlafaxine and milnacipran were similar in the patients of MDD but with mild increase in blood pressure in venlafaxine treated patients.

NEU-17

A comparative analysis of fixed combinations of latanoprost/timolol vs. dorzolamide/timolol in primary open angle glaucoma or ocular hypertension

Sukhsagar Ratol , Rani Walia, Mridu Chowdhary, Akarsh Bajaj

MMIMSR, Mulana, Ambala, Punjab

Objective: To compare the efficacy and tolerability of the fixed combination latanoprost and timolol instilled once daily in the evening vs fixed combination of Dorzolamide and timolol instilled twice daily in primary open angle glaucoma or ocular hypertension. Materials and Methods: A 12-week, randomized, open, parallel group study including 50 patients with primary open angle glaucoma or ocular hypertension was conducted at ophthalmology deptt at MMIMSR, Mullana. Patients giving the informed consent and fulfilling the eligibility criteria were randomized to group 1,n=25( FC latanoprost and timolol eye drops, once daily in evening) and group 2,n=25 (FC dorzolamide and timolol eye drops, twice daily).At baseline, 2 weeks,4 weeks and 12 weeks IOP was recorded at 9AM and 12 noon. Any adverse drug reactions were inquired, analysed and recorded at each visit. The difference in IOP reduction in two treatment groups from baseline to 12 weeks was the main outcome measure. Results: Mean diurnal IOP was similar at baseline for both groups. Mean reduction in IOP from baseline to 12 weeks was 9.92mm Hg (p=0.001) in group 1 and 9.22 (p=0.001) in group 2. The reduction in IOP in both group 1 and 2 was statistically significant at all time intervals. There was a statistically significant advantage for group 1 at 12 weeks for both time readings (p=0.013 and 0.002 respectively) as compared to group 2.Both treatments were generally well tolerated. Conclusions: The fixed combination of latanoprost and timolol was more effective than that of dorzolamide and timol in reducing mean diurnal IOP and both treatments were well tolerated.To confirm further such studies are required.

NEU-18

The effect of diltiazem on the antidepressant effect of imipramine and venlafaxine in vivo in rats

Rajesh K. , Bhalerao S.

Department of Pharmacology, Padmashree Dr. D.Y. Patil Medical College, Pimpri, Pune - 18, India.

Objective: To evaluate antidepressant like effect of diltiazem in rats . Introduction: Results of numerous pre-clinical studies have demonstrated that calcium channel blockers have an antidepressant activity and a potential for interaction with standard antidepressants. The present study is designed to test this hypothesis in rats. Materials and Methods: Rats were assigned to six groups, one group is the control group (distilled water), three groups are, imipramine (10 mg/kg), venlafaxine (20 mg/kg), and diltiazem (20 mg/kg) alone and other two groups are combination of diltiazem with imipramine, and diltiazem with venlafaxine. To know the antidepressant effect, forced swim model had been used, the immobility period of all the groups are compared with each other after giving drugs for 7 days. Results: Diltiazem produced significant antidepressant effect either alone or in combination with imipramine and venlafaxine. The efficacy of diltiazem (20 mg/kg) was comparable to that of imipramine (10 mg/kg) and venlafaxine (20 mg/kg). Discussion and Conclusion: The results of the present study indicate antidepressant like activity of diltiazem.

NEU-19

Acetaminophen attenuates compulsive-like effect in mice

Shyamshree S.S. Manna , Rupali A. Sondawale, Sudhir N. Umathe

Department of Pharmaceutical Sciences, RTM Nagpur University, Amravati road, Nagpur - 440 033, Maharashtra, India.

Objectives: Studies have shown the involvement of endocannabinoid and serotonergic systems in antinociceptive effect of acetaminophen. Interestingly, both the systems have shown to be involved in pathophysiology of obsessive-compulsive behavior. Thus, the objective of the present study was to investigate whether acetaminophen exhibit anti-compulsive effect in mice. Materials and Methods: Separate groups (n=7) ofSwiss male mice (20-25g) were subjected to marble-burying behavior and DOI-induced head twitches, afterintraperitoneally administration of acetaminophen (50, 100, or 200 mg/kg), or fluoxetine (2.5, or 5 mg/kg, i.p.) or intracebroventricular administration of anandamide (a CB1 agonist:1, 5, and 10 μg/mouse, i.c.v.). The effects of acetaminophen in mice pre-treated either with AM251 (a CB1 antagonist: 1 mg/kg, s.c.), anandamide (5 μg/mouse, i.c.v.), PCPA (300 mg/kg/day, i.p. X 3 days) or fluoxetine (2.5, or 5 mg/kg, i.p.) were studied. Results: Acetaminophen dose-dependently decreased the burying behavior as well as DOI-induced head twitches similar to that of anandamide and fluoxetine. Pre-treatment of AM251 as well as p chlorophenylanaline (PCPA) antagonized the effects of acetaminophen in both the models. Lastly, co-administration of acetaminophen in sub-effective dose potentiated the effects of fluoxetine or anandamide in both the tests. Conclusions: Thus, the results of the present study indicate that acetaminophen exhibits anti-compulsive-like effect in mice and might be beneficial in the delayed anti-compulsive effect of fluoxetine.

NEU-20

Antidepressant like activity of (4-phenylpiperazin-1-yl) (quinoxalin-3-yl) methanone(4a), a novel 5 ht3 receptor antagonist: An investigation in behaviour-based rodent models

Baldev Kumar , Ankur Jindal, Dilip Kumar Pandey, Shvetank Bhatt, Thangaraj Devadoss, Radhakrishnan Mahesh

Department of Pharmacy, Birla Institute of Pharmacy, Pilani, Rajasthan, India.

Objective: The present study was designed to investigate the antidepressant potential of (4-phenylpiperazin-1-yl) (quinoxalin-3-yl) methadone (4a), a novel 5-HT 3 receptor antagonist, with an optimal log P (2.84) and pA 2 value (7.3) greater than ondansetron (pA 2 - 6.9) using rodent behavioural models of depression. Materials and Methods : Swiss albino mice were used in actophotometer test, forced swim test (FST), tail suspension test (TST) and 5-hydroxytryptophan (5-HTP) induced head twitch response, whereas reserpine induced hypothermia (RIH) and olfactory bulbectomy were performed in male wistar rats. Results: Acute treatment of 4a in mice produced antidepressant-like effects in FST and TST without affecting the baseline locomotion in actophotometer test. Interaction studies were carried out with standard antidepressants like venlafaxine and bupropion. 4a (1-2 mg/kg, i.p.) significantly augmented the antidepressant action of venlafaxine (4 mg/kg, i.p) and bupropion (10 mg/kg, i.p) in the mouse FST and TST respectively. Furthermore, 4a potentiated the 5-HTP induced head twitches response in mice and also antagonized RIH in rats. Chronic treatment (14 days) with 4a and paroxetine significantly reversed the behavioural anomalies induced by bilateral olfactory bulbectomy in rats in modified open field exploration. Conclusion: These preliminary investigations confirm that 4a exhibits antidepressant-like activity in acute and chronic rodent models of depression.

NEU-21

Effect of levacecarnine on seizure threshold in animal models of anti-convulsants


S. Mohanty, S. Mohapatra, K.P. Pattnaik, T.R. Swain, G. Kumar

Department of Pharmacology, S.C.B. Medical College, Cuttack, Odisha, India.

Objectives: This study aims to evaluate the effect of Levacecarnine (L-Acetyl Carnitine) shown to have a beneficial role in neurodegenerative disorders in humans, on seizure threshold in animal models. Materials and Methods: Albino rats(100-150gms) and albino mice (20-25gms) of either sex were used for Maximal Electroshock Seizure (MES) and Pentylenetetrazol (PTZ) induced convulsions respectively. The animals were divided into 4 groups of 6 animals each. Group 1 served as control, Group 2 were administered Levacecarnine 50mg/kg/day, Group 3 was administered Levacecarnine 100mg/kg/day orally for a period of 7 days and 15 days and thereafter the animals were tested in MES and PTZ models. The effects were compared with the control drug Phenytoin 20mg/kg administered intraperitoneally to Group 4 animals. Results: Levacecarnine was found to have a decremental effect on the seizure threshold. The onset as well as the duration of seizure was observed to be similar to that of the Phenytoin group.No mortality was noted in any of the four groups. Conclusion: The present study reveals Levacecarnine to have significant seizure threshold lowering effect when tested in animal models of anti-convulsants.


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PKN-1

Study on the pharmacokinetic drug-drug interaction potential of morin with pioglitazone in rats

Prashant B. Musmade , Swapnil J. Dengale, K. L. Bairy 1 , M. S. Reddy, N. Udupa

Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, 1 Department of Pharmacology, Kasturba Medical College, Manipal University, Manipal - 576 104, India.

Objective : The present study was aimed to understand drug interaction of pioglitazone with morin which is metabolized by multiple CYP enzymes, mainly by CYP3A and CYP 2C. Morin belongs to class of flavonoids having the ability to modulate CYP450 activity. Materials and Methods: In-vitro drug metabolism studies of pioglitazone in presence and absence of morin were carried out in the rat liver microsomes. The single pass intestinal perfusion in-situ studies were carried in the intestine. In-vivo pharmacokinetic studies of pioglitazone were carried out in rats in presence and absence of morin. Estimation pioglitazone was carried out using HPLC method. Results : In vitro studies in rat liver microsomes showed that, the percentage remaining of pioglitazone in control and in presence of morin was found to be 62.62±6.40 and 86.86±10.38 % respectively. In-situ study revealed the significant difference in Peff of pioglitazone in presence of morin compared to pioglitazone. In vivo pharmacokinetic studies showed that Cmax and AUC (0-∞) after oral administration raised by 1.4 and 1.8 fold respectively whereas there was increase in AUC (0-∞) by 1.3 fold after intravenous administration of pioglitazone in presence of morin compared with pioglitazone. There was a significant decrease in the elimination rate constant K el ) of pioglitazone in oral and intravenous administration in presence of morin compared with pioglitazone control which results prolongation of half-life of pioglitazone. Conclusion: These results indicate that there is drug interaction of morin with pioglitazone may be due to inhibition of CYP3A and CYP2C enzymes mainly responsible for metabolism of pioglitazone.


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RDU-1

Pattern of use of antimicrobials in patients following snake bite in a tertiary care centre

Palappallil Dhanya , Kala Kesavan P.

Department of Pharmacology, Government Medical College, Kottayam, India.

Objectives: The routine prophylactic use of antibiotic after snake bite is controversial. This study was done to determine and describe the pattern of antimicrobial usage after snakebite in atertiary care centre. Materials and Methods: Retrospective review of case records from January to August 2011 was done and all the cases filed as snakebite were reviewed and details entered in a structured proforma. Data was analysed using SPSS 16. Results : 313 cases were evaluated with median age 39 and male: female ratio 1.25:1. 31.9 %( 100) were venomous bites of which 53% had local envenomation and 47% systemic. Lower limb (89.8%) was the commonest site of bite. 16.3% received first aid in local hospital. Mean stay in hospital was 3.13±1.304 and there were 5 deaths.95.2% received antibiotics of which 82.7% were oral, 6.7% parenteral and 5.7% both. 7 different types of antibiotics were prescribed alone or in combination of which Cloxacillin was the commonest (35.14%) followed by Ampicillin (33.2%). Ampiclox in a dose of 500 mg (250 mg each) was prescribed in 30.03%. 94.4% with no envenomation received antibiotics mainly Cloxacillin. Intravenous antibiotics were given only in patients witheither local or systemic envenomation.Antisnake venom (mean 3.67±6.83 vials) was administered in 32.2% of which 41.5% developed anaphylaxis. Proton pump inhibitors were prescribed to 100%. Conclusion: Prophylactic use of antibiotics is a common practice in this hospital considering the risk of infection.Ampiclox 500 mg due to inadequate dose is irrational and its use should be discouraged as it promotes bacterial resistance.

RDU-2

Drug prescription pattern of outpatients in a tertiary care teaching hospital in Maharashtra

Lalan B.K ., Singh K., Manu H.C., Patil S.P., Hiray R.S., Ghongane B.B.

Department of Pharmacology, B.J. Medical College and Sassoon General Hospital, Pune - 411 001, Maharashtra, India.

Objectives: To study the drug prescribing pattern and evaluate the rationality of the prevalent prescribing practices. Materials and Methods: A cross sectional descriptive study was conducted in the Out Patient Department of Sassoon Hospital. Total of 1200 prescriptions (average daily OPD attendance) were randomly collected over a period of 10 days from the pharmacy of the hospital and were recorded over a specially designed proforma. The data was then analyzed to find out the prescribing pattern in the hospital using the WHO prescribing indicators. Results: Average number of drugs per encounter was 3.62. Encounter with an antibiotic prescribed was 46.17% and with a Fixed Dose Combination (FDC) it was 46.67%. Encounter with an injection was only 0.17%. The most commonly used group of drug was Vitamins and Minerals (24.44%), followed by Analgesics (17.76%), Antimicrobials (16.59%) and Antiulcer drugs (16.49%). The most common drug prescribed was Ranitidine (15.89%), followed by Vitamin B complex (11.03%) and Diclofenac (10.69%). The most common antibiotic prescribed was Ciprofloxacin (3.80%), followed by Amoxicillin (3.73%) and Metronidazole (2.30%). Conclusions: The present drug utilization study is to give feedback to the prescribers, so as to create awareness about the rational use of drugs. The present prescribing practices are far from satisfactory. They can be improved by conducting CMEs and promotional workshops for medical personnel regarding rational use of drugs.

RDU-3

A study of prescription pattern in the drug therapy of ENT infections in a Rural Teaching Hospital, Sullia

Guruprasad N.B. , Vijayaraghavan S., Rajasekhar C.H.

Department of Pharmacology, K.V.G. Medical College, Sullia, D.K, Karnataka, India.

Objectives: To study the pattern of drug utilization of the antimicrobial agents (AMAs) and the adjunctive drug therapy for ENT infections in a rural teaching hospital. Materials and Methods: Over a period of 5 months, 512 patients were selected in K.V.G Medical college hospital. Details of diagnosis, investigations, antimicrobials, and adjunctive medications prescribed were collected in a specially designed proforma. Descriptive analysis of data was done. Results : The study showed that in the 512 prescriptions, a total of 524 AMAs were used i.e., 1.02 AMAs per patient. The AMAs were indicated therapeutically in 79.68%, prophylactically in 9.16% and both in 11.16% patients. In the adjunctive therapy, antihistamines (39.46%) and NSAIDs (25.20%) were used. Among the infections reported the most common was URTI (38.26%) followed by ASOM (19.53%), otomycosis (11.71%), CSOM (10.15%), otitis externa (5.4%). Out of 512 patients' culture and sensitivity was performed in 92 patients and only 36 showed bacterial isolate. The commonest microbes isolated were staphylococcus aureus (33.3%) and pseudomonas (33.3%). Most (53%) prescriptions contained 2 AMAs. The preferred combination was cefpodoxime plus dicloxacillin (35.15%). The preferred route for administration of the drugs was oral. Most causative microbes were sensitive to the β-lactam group of drugs (53.4%), and resistant to erythromycin and tetracycline. Conclusion : The study shows that ENT infections in this hospital were treated in accordance with standard practice guidelines.

RDU-4

Role of information, education and communication in impoving adherence to artemether-lumefantrine combination in patients of uncomplicated plasmodium falciparum malaria in Orissa

*Trupti Rekha Swain , Anshupa Raulo, Namita Mohapatra

Department of Pharmacology, SCB Medical College and Hospital, Cuttack, Orissa, India.

*E-mail: drtruptiswain@yahoo.com

Objectives : Malaria is a major public health problem in Orissa. Successful completion of total dose in appropriate time is very important to prevent the patients from going to complications. One study in Thailand has shown that proper use of information, education and communication (IEC material) can increase drug adherence and improve drug use in Vivax malaria. Materials and Methods : This study was conducted in OPD patients of Medicine and Pediatrics departments of SCB Medical college, Cuttack .150 patients and 20 control patients diagnosed as uncomplicated Plasmodium falciparum malaria either by rapid diagnostic tests / slide test were randomly selected. Approval of Ethics Committee was obtained. Both participatory learning and diagrammatically drawn drug bag was used as IEC to facilitate ACT use. Importance of use of drug after a fatty meal / milk, role of adherence to the specified dose schedule was highlighted. Result: Adherence to proper dosing schedule of the drug was significantly higher in patients receiving IEC (81 %). Demographic parameters like age, sex and socio-economic status of the patients, had no influence on adherence. (p >0.05) On the contrary, educational status of the patient and geographical area of the patient was found out to affect adherence to IEC in a significant extent.

RDU-5

Use of antibiogram to assess the prescription pattern in Govt Medical College and Hospital, Amritsar

Upveja K.H. , Paul S., Rai J., Singh J., Kaur I.P.

Department of Pharmacology, Government Medical College, Circular Road, Amritsar, Punjab, India.

Objective: 1. To prepare antibiogram for the indoor patients of Government Medical college and hospital. 2. To detect and monitor trends in resistance . 3. Compare susceptibility rates and prescribing patterns across the institution. Materials and Methods : This retrospective study was conducted to evaluate culture sensitivity reports prepared by Department of Microbiology of 1000 indoor patients admitted to the Government Medical College and Hospital, Amritsar between May 2011 to July 2011. Reports were compiled to make the antibiogram. 1500 indoor antibiotic prescriptions within the same time span were collected .The data was then compared and analyzed accordingly. Results : After analyses it was found that the most common organism in Pulmonary Medicine was Pseudomonasaeruginosa (35%), found most susceptible to amikacin (86%) and piperacillin/tazobactum (41%). But the commonly prescribed antibiotics were amoxycillin/clauvulinic acid (65%) followed by ceftriaxone (42%). Similarly, the results from Medicine showed Escherichia coli (42%) susceptible to amikacin (77%) but among the prescribed drugs were ceftriaxone (32.5%) and amoxycillin/clauvulinic acid (14%). In Surgical departments Staphylococcus aureus and Escherichia coli were the most common organisms. In Surgery sensitivity pattern was amikacin (57%) followed by piperacillin/tazobactum (31%) and the prescribed drugs were amikacin (74%) followed by amoxycillin/clauvulinic acid (50%) and piperacillin/tazobactum (48%). In Orthopedics sensitivity pattern was amikacin (58%) followed by linezolid (27%) and the prescribed drugs were amikacin (90%) followed by cefoperazone/sulbactum (65%). In Obstetrics and Gynaecology sensitivity pattern was amikacin (84%) followed by gentamycin (45%) and the prescribed drugs were gentamycin (64%) followed by cefotaxime/sulbactum (45%). Conclusion : Antibiograms are useful in predicting the outbreaks of infections in the institution and in monitoring the trends of antimicrobial resistance. The survey revealed a clear mismatch between the sensitivity reports and the prescribing trends which can lead to emergence of multi-drug resistant organisms. To control this menace, institutions should have a multidisciplinary process in place to review local antibiograms and regulate antibiotic prescribing to enhance its appropriate use. Rational use of antibiotics is essential for their continued effectiveness.

RDU-6

Rationality versus irrationality in fixed dose combinations At a tertiary teaching hospital of rural India

Ahmed Tabish , Jha R.K., Ghia Canna, Kaikade Swapnil, Rathod Roheet, Giri Kiran R.

Jawaharlal Nehru Medical College, Sawangi, (Meghe), Wardha, Maharashtra, India.

Objectives: To assess knowledge about fixed dose combinations amongst clinicians of rural hospital, attitude about rationality and irrationality and practice of prescribing rational fixed dose combinations. Materials and Methods: A prospective observational study was conducted, total 300 patients attendingmedicine OPD of rural hospital in Wardha district were interviewed and their prescriptions were analysed. Results: Total 350 drugs were prescribed, 60(17.14%) were prescribed by generic name and the rest 290 (82.86%) were prescribed by brand name. Only 18 (5.14%) drugs were not prescribed from hospital formulary. 264 (75.43%) drugs were dispensed from hospital pharmacy. On the basis of rationality score 53% prescriptions were rational, 30% semi rational and 17% irrational. Average rationality score was 20.56. Conclusion: In a rural hospital, where hospital formulary is based on WHO Essential medicine list, hundred percent utilization of hospital pharmacy service doctors and patients would ensure rational prescribing benefits of the patients coming from rural and uneducated background.

RDU-7

Knowledge, attitude and practice of pharmacovigilance among medical professionals at a tertiary care hospital in Mumbai

Vijay K. , James J., Neha K., Sudhir P.

Department of Pharmacology, LTM Medical College and General Hospital, Sion, Mumbai - 400 022, India.

Objective: To assess the knowledge, attitude and practice related to pharmacovigilance among medical professionals at a tertiary care hospital in Mumbai. Materials and Methods: With the approval of Institutional Ethics Committee, 150 medical teachers and postgraduate resident doctors were evaluated for their knowledge, attitude and practice of pharmacovigilance with the help of a questionnaire. Questionnaire also sought their demographics along with suggestions for improving the effectiveness of the pharmacovigilance practices. Results: Of the total 150 participants, 73 (48.7%) were males and 77 (51.3%) were females. 91 (60.7%) postgraduate students and 59 (39.3%) teaching staff participated in study. 144 (96%) believed that pharmacovigilance is important in medical practice but only 119 (79.3%) knew the definition of pharmacovigilance. Only 37 (24.7%) were aware about the existing Pharmacovigilance Programme of India (PvPI). 39 (26%) knew about WHO Uppsala monitoring centre. 144 (96%) believe that it is duty of the treating physician to report an ADR while 55 (36%) felt that ADR reporting should be a responsibility of separate team. More than fifty percent, [n=81, 54%] felt that financial aid should be provided for ADR reporting. 64 (42.7%) have not reported any ADR whilst only 24 (16%) have reported more than 10 ADRs in their career. 73 (48.7%) spend time to explain to the patients about possible ADRs. 103 (68.7%) never attended any workshop or CME related to the pharmacovigilance. Most common expectation from the pharmacovigilance centre was to create an ADR database [n=119, 79.3%]. Most common measure suggested for improving effectiveness of pharmacovigilance was continued medical education and training [n=148, 98.7%]. Conclusion: The study identifies that inspite of having fair attitude; there is poor practice of ADR reporting probably because of lack of knowledge about the pharmacovigilance. Motivation through continued medical education and training is needed to improve and strengthen pharmacovigilance practices.

RDU-8

Prescribing pattern of antihypertensives in individuals with hypertension alone and with coexisting diabetes mellitus - A comparative study

Keerthi Sagar J. , Narendranath S., H.S. Somashekar, Reshma S.R., Susheela S. Halemani, Prabakar Adake

Department of Pharmacology, JJM Medical College, Davangere - 577 004, Karnataka, India.

Objective: Analysis of prescribing pattern of antihypertensives in patients with hypertension alone and with coexisting diabetes mellitus. Materials and Methods: A cross sectional study was conducted in an out patient and in patient department of general medicine at JJM Medical College hospital for a period of 3 months (July 2011 to September 2011). Prescriptions of the patients were collected and relevant data was entered in the preformed proforma and analyzed. Results : A total of 210 prescriptions were analyzed using Chi square test. Out of which 126 prescriptions were of patients with hypertension alone which contain calcium channel blockers (30%), beta blockers (26%), angiotensin receptor blockers (15%), angiotensin converting enzyme inhibitors (4%) and fixed drug combinations of angiotensin receptor blockers with hydrochlorthiazide (11%) and combination of amlodipine with hydrochlorthiazide (2.5%). 84 Prescriptions of hypertension with coexisting diabetes mellitus had calcium channel blockers (24%), angiotensin converting enzyme inhibitors (19%), angiotensin receptor blockers (13%), beta blockers (13%), and fixed drug combinations of angiotensin receptor blockers with hydrochlorthiazide (18%) and combination of amlodipine with hydrochlorthiazide (6%).[χ2 =17.01, P=o.oo4]. Conclusion : The present study shows that angiotensin converting enzyme inhibitors because of its beneficial effects which are well known are more commonly prescribed drugs in individuals with hypertension with coexisting diabetes mellitus. Calcium channel blockers and newly introduced angiotensin receptor blockers alone or in combination with hydrochlorthiazide are preferred drugs in both the study groups. Beta blockers are less preferred in patients of hypertension with coexisting diabetes mellitus for obvious reasons.

RDU-9

Drug utilization pattern of non steroidal anti-inflammatory drugs in combination with gastroprotective agents in orthopedic outpatient department

Abhishek Rahim , Asawari Raut, Sanjay Patil, Goutham Reddy, Nitin Dalvi

Department of Clinical Pharmacy, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, Maharashtra, India.

Aim: To assess the drug utilization pattern of Nonsteroidal anti-inflammatory drugs in combination with gastroprotective agents in orthopedic outpatient department. Materials and Methods: A prospective observational study was conducted at orthopedic OPD of Bharati Hospital during May 2011 to July 2011. Four hundred patients receiving NSAIDs either as monotherapy or in combination with gastroprotective agents were evaluated for diagnosis, reason for initiating therapy, dose, frequency and duration of the therapy. The drug use indicators were determined and average cost per prescription was calculated. Results: A total of 400 patients (male 202 and female 198) received oral NSAIDs with an average age of 38.9 years. 364 of them received a combination with gastroprotective agents. Diclofenac was the most common NSAID prescribed followed by aceclofenac. Most common gastroprotective agent was H 2 blocker, which was prescribed for 196 encounters, followed by Proton Pump Inhibitors. A large number of patients were initiated NSAID therapy due to the complaint of pain. Average dose of NSAID was found to be 50-75 mg with frequency of two times a day and for 5-7 days of duration. Average cost per prescription was found to be Rs.70.63. Conclusion: Diclofenac induced gastric damage is common and is well managed by proton pump inhibitors. However it was observed that H 2 blockers were the choice of drug for majority cases.


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RSP-1

A study of prescribing pattern of drugs for bronchial asthma of indoor patients in a tertiary care teaching hospital in Dakshina Kannada district, Karnataka

Srinivas Bhat U. , Mohandas Rai, Sharath Kumar, Rashmi R. Rao

Department of Pharmacology, A. J. Institute of Medical Sciences, Mangalore - 575 004, Karnataka, India.

Objective: To study the prescribing trends of drugs for bronchial asthma of indoor patients in a tertiary care teaching hospital in Mangalore. Materials and Methods: In this retrospective study a total of 100 prescriptions of indoor patients were studies and the relevant information was entered into preformed proforma and were analysed for various parameters. Results: Out of the 100 prescriptions studied the number of drugs prescribed for bronchial asthma alone was 20. Among these drugs Intavenous Hydrocortisone was given followed by tapering doses of oral prednisolone in 44% of the cases. Among the bronchodilators 52% of the cases received intravenous deriphylline followed by oral deriphylline whereas 48% received only oral deriphylline. Salbutamol nebulization was administered concurrently in 72% of the cases whereas ipratropium bromide nebulization was administered in 42% of the cases. Ciprofloxacin and ranitidine was the commonest antibiotic and antiulcer drug used to combat associated infection and gastric acidity in 56% and 92% cases respectively. Conclusion: Fixed drug combinations are used to treat patients of bronchial asthma in this hospital which corresponds to as mentioned in the GINA guidelines where bronchodilators, corticosteroids and antibiotics are prescribed together. A combination of intravenous hydrocortisone followed by tapering doses of oral prednisolone, intravenous followed by oral deriphylline, asthalin and ipravent nebulization, oral ciprofloxacin and ranitidine was most commonly prescribed.


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TOX-1

Analysis of pattern and outcome of poisoning cases in a tertiary care hospital in south India. Do pharmacologists have a role in the management of poisoning cases?

*Harivenkatesh N. , Darling Chellathai David, Prabhakar Reddy C.

Department of Pharmacology, Sri Ramachandra Medical College and Research Institute, Chennai - 116, India.

*E-mail: dr_harivenkatesh@yahoo.co.in

Introduction: Acute poisoning is a common cause for Emergency department admissions. Poisoning agents vary in different places. Data regarding poisoning pattern/trends is meager in India. We aimed to analyze the pattern and outcome of acute poisoning cases admitted in our tertiary care hospital. Materials and Methods: All poisoning cases (Suicidal, Accidental and Homicidal) irrespective of age and gender, admitted in Emergency Department of our hospital during the year 2010 were studied after obtaining IRB approval. Information regarding socio-demographic characteristics, agents and cause of poisoning, symptoms, clinical course, outcome and severity was collected and analyzed. Results: 421 acute poisoning cases were admitted in the year 2010. Male: Female ratio was 1.2:1. 56% of poisoning cases were unmarried. 79% resided in urban areas. 67% (n=282) of the cases were suicidal, 32.8% (n=138) were accidental and 0.2% (n=1) was homicidal. Acute poisoning was common in 21-30 years age-group (36.1% n=152) followed by 11-20 years age-group (19.7% n=83). Common poisoning agents were Drugs (30.2%), Organophosphorus compounds (11.6%), Snake venom (8.6%), Rat-killer poison (7.4%), Corrosive acid/alkali (7.4%), Pyrethroids(5.5%) and Oleander seeds(4%). Mortality rate was 2.9% (n=12). Majority of deaths were due to OPC (41.7% n=5). According to poisoning severity score, 18.8% (n=79) had severe poisoning. Antidote was required for 33.7% (n=142) and mechanical ventilation for 15.7% (n=66) of cases. Discussion: Patients who presented directly to the hospital without delay had significantly better outcome than those who presented late after getting first aid at peripheral centers (χ2 =19.7, p<0.01). Time lag had a significant influence on the outcome. Conclusion: Effective prevention and treatment strategies should be developed to reduce poisoning related mortality and morbidity. Clinical Pharmacologists can setup drugs and poisons information center and collaborate with clinicians for better management of poisoning cases.

TOX-2

Evaluation of hepatoprotective activity of vitex negundo linn. leaf extract against paracetamol induced liver damage in rats

Thakuria B. , Lahkar M., Bezbaruah B.K.

Department of Pharmacology, Gauhati Medical College, Guwahati, Assam - 781 032, India.

Objectives: To evaluate the hepatoprotective activity of Vitex negundo Linn. leaf against Paracetamol induced hepatotoxicity in rats. Materials and Methods: Liver damage was induced in 30 albino rats by Paracetamol (650 mg/kg i.p.) once daily for 7 days. Silymarin was taken as the standard drug in a dose of 25 mg/kg PO. For this Albino Wistar rats (150-200 g) were divided into 5 groups containing 6 rats each .Group I - Control (received Normal Saline) , Group II - Paracetam-ol (650 mg/kg i.p. × 7 days), Group IIIa - V. negundo ethanolic extract (100 mg/kg PO × 14 days) + Paracetamol (650 mg/kg i.p. from the 7 th to the 14 th day) , Group IIIb - V. negundo ethanolic extract (300 mg/kg PO ×14 days) + Paracetamol (650 mg/kg i.p.from the 7 th to the 14 th day), Group IV - Silymarin (25 mg/kg PO ×14 days) + Paracetamol (650 mg/kg i.p. from the 7 th to the 14 th day) . On the 14 th day blood was collected from the animals by retro-orbital puncture and serum separated by centrifugation and estimation of biochemical parameters (SGOT, SGPT, ALP, proteins and bilirubin). These were supplemented by Pentobarbitone sleeping time and liver histopathology. Data was analyzed by one-way ANOVA, followed by Schiff's/Dunnett's test. Results : Ethanolic extract of V.negundo leaf resulted in statistically significant (P<0.05) reduction in paraceta- mol induced elevated liver enzymes and proteins. Pentobarbitone sleeping time and liver histopathology yield-ed consistent results. Conclusions: Ethanolic extract of V. negundo leaves shows hepatoprotective effect in paracetamol induced liver damage.

TOX-3

Ciprofloxacin residues in pork of Assam and its public health significance

D.C. Roy* , R. Gogoi, M. Gogoi, L.C. Lahon, S.K. Laskar, A. Chakraborty

Department of Pharmacology and Toxicology, College of Veterinary Science, Assam Agricultural University, Khanapara, Guwahati - 781 022, India.

*E-mail: roydula@gmail.com

Pork contributes about 39% of total meat share in Assam. Most of the people of Assam are avid consumers of pork. Presence of Ciprofloxacin, an antibacterial agent used in farm pigs may be found as residues in meat of slaughterd pig. The people of Assam may risk the chances of Ciprofloxacin residue in pork. Thus, the present study was undertaken to detect the presence of Ciprofloxacin residue in pork. 200 nos. of representative pork samples were collected from different pork markets of Assam. The samples after collection were preserved at -20°C. Analyses of the samples were done using High Performance Liquid Chromatography with UV-Vis Detector as per the method of Salehzadeh et al.,2007 with slight modification. Ciprofloxacin residues were extracted with Phospate buffer. Solid phase extraction clean up was done with Sep-pak C 18 cartridge. Recovery ranged from 78-88%. Out of the collected samples, 14 nos. (7%) of the screened samples were detected to be positive for trace residues of Ciprofloxacin which were below the MRL value. It may be concluded that the analyzed samples were well below the MRL which may be an indication of its safe consumption.




 

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