BackgroundRoot extracts of Withania somnifera (Ashwagandha) are known to possess analgesic, anti-inflammatory and chondroprotective effects. An aqueous extract of roots plus leaves of this plant has shown to yield higher percentages of withanolide glycosides and, accordingly, may possess better analgesic, anti-inflammatory and chondroprotective effects than root alone extracts.ObjectivesTo evaluate efficacy and tolerability of a standardized aqueous extract of roots plus leaves of W. somnifera in patients with knee joint pain and discomfort.Material and methodsSixty patients with knee joint pain and discomfort were randomized in a double-blind manner to W. somnifera 250 mg, W. somnifera 125 mg and placebo, all given twice daily. Assessment was done by Modified WOMAC, Knee Swelling Index (KSI), Visual Analogue Scale (VAS) at baseline and at the end of 4, 8, 12 weeks. Tolerability was assessed by incidence of adverse effects in treatment groups. Student's ‘t’ test and ANOVA were used to compare mean change from baseline within and between the study groups. A p < 0.05 was considered significant.ResultsAt the end of 12 weeks, compared to baseline and placebo, significant reductions were observed in mean mWOMAC and KSI in W. somnifera 250 mg (p < 0.001), W. somnifera 125 mg (p < 0.05) groups. VAS scores for pain, stiffness and disability were significantly reduced in W. somnifera 250 mg (p < 0.001), W. somnifera 125 mg (p < 0.01) groups. W. somnifera 250 mg group showed earliest efficacy (at 4 weeks). All treatments were well tolerated.ConclusionsBoth the doses of an aqueous extract of W. somnifera produced significant reduction in outcome variables, with the 250 mg group showing significantly better response. In addition, the therapeutic response appears to be dose-dependent and free of any significant GI disturbances.

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ObjectivesTo evaluate the efficacy and tolerability of standardized aqueous extracts of Terminalia chebula and Terminalia bellerica versus febuxostat and placebo on reduction in serum uric acid levels in subjects with hyperuricemia.Materials and methodsA total of 110 eligible subjects with hyperuricemia were enrolled and randomized to either of the five treatment groups – T. chebula 500 mg twice a day (BID), T. bellerica 250 mg BID, T. bellerica 500 mg BID, placebo BID, and febuxostat 40 mg once daily plus an identical placebo – for a duration of 24 weeks. Serum uric acid levels were measured at baseline and at the end of 4, 8, 12, 16, 20, and 24 weeks. Statistical analysis was done using GraphPad Prism Software 4.Results and interpretationAll active treatment groups showed a reduction in serum uric acid levels compared to baseline and placebo. Significant reduction in mean serum uric acid levels started as early as 4 weeks following treatment, compared to baseline, with T. bellerica (500 and 250 mg), febuxostat (P<0.001), and T. chebula 500 mg (P<0.01); an increase in serum uric acid levels was seen with placebo (P<0.05). The serum uric acid levels became steady after 16 weeks of treatment and remained the same until the end of 24 weeks. The reduction of serum uric acid levels in the T. bellerica 500 mg group was nearly twice that of the T. chebula 500 mg group as well as T. bellerica 250 mg group at all time points. T. bellerica 500 mg reduced serum uric acid levels from 8.07±0.87 to 5.78±0.25 compared to febuxostat, which reduced serum uric acid levels from 8.53±0.97 to 4.28±0.67 (P<0.001) at the end of 24 weeks. The efficacy of T. bellerica appeared to be dose dependent. All the formulations were well tolerated.ConclusionT. bellerica has the potential for treating hyperuricemia as it was devoid of any serious adverse effects in the present study. Further studies are needed to confirm this potential.

Background: Adverse drug reactions (ADRs) are common cause of morbidity in the practice of medicine. Pharmacovigilance is the science of detection, assessment and understanding and prevention of adverse effects or any drug related problems. Post graduates are perhaps the first to notice ADRs in outpatient/inpatient setup as they spend most of the time bedside. Thus, this study was conducted to assess the knowledge, attitude and practices (KAP) of postgraduates about Pharmacovigilance.Methods: A prevalidated and pretested questionnaire with 20 questions related to KAP of pharmacovigilance is administered to postgraduate students after obtaining their consent. All the completed and returned questionnaires were analysed for results using appropriate statistics.Results: 180 pretested questionnaires were distributed among postgraduates out of which, 122 were returned from postgraduates of all major medical and surgical allied departments. 90.2 % defined pharmacovigilance correctly, 83.6% thought reporting ADRs is a professional obligation, while only 65.6% knew regarding the existence of national pharmacovigilance program. 58.4% have experienced ADRs, of which only 24.6% reported ADR to pharmacovigilance centre. Major reasons for under reporting are lack of time to report and difficulty to decide whether ADR has occurred or not.Conclusions: In this study, the knowledge and attitude related to Pharmacovigilance is good amongst postgraduates, but practical implementation in reporting of ADRs is poor. Sensitization programs on pharmacovigilance practice in tertiary care hospitals and regular review meetings to ensure ADR reporting to pharmacovigilance centre will strengthen the health care setup.

Background and Aims:To evaluate analgesic activity and safety of single oral dose (1000 mg) of Terminalia chebula using a mechanical pain model in healthy human volunteers.Material and Methods:Twelve healthy volunteers were randomized to receive either single oral dose of 2 capsules of T. chebula 500 mg each or identical placebo capsules in a double-blinded manner. Mechanical pain was assessed using Ugo basile analgesy meter (Randall–Selitto test) before and 3 h after administration of test drug. The parameters evaluated were pain threshold force and time; pain tolerance force and time. A washout period of 1-week was given for crossover between active drug and placebo.Results:Terminalia chebula significantly increased the mean percentage change for pain threshold force and time, and pain tolerance force and time compared to placebo (P < 0.001). The mean percentage change for pain threshold force and time (20.8% and 21.0%) was increased more than that of pain tolerance force and time (13.4% and 13.4%). No adverse drug reaction was reported with either of the study medications during the study period.Conclusion:T. chebula significantly increased pain threshold and pain tolerance compared to placebo. Both the study medications were well tolerated. Further multiple dose studies may be needed to establish the analgesic efficacy of the drug in patients suffering from osteoarthritis, rheumatoid arthritis and other painful conditions.