Implementation of an educational program to promote research ethics in undergraduate medical students.

BACKGROUND: MBBS students lack training in research ethics which is crucial when they enter clinical practice and venture into clinical research in future. This study was planned to implement an educational module to build concepts in research ethics. OBJECTIVE: To assess the change in the knowledge and attitude of medical students towards research ethics. METHODS: The study was initiated after obtaining institutional ethics committee approval. It was an interventional study, conducted on 2nd MBBS students (N=130) subjected to an educational program which comprised of three modules viz., theme lectures, educational visits and small group case based learning. A prevalidated questionnaire(35 items), was administered at baseline and at the end of 3 modules, to assess the change in the knowledge gained and in the attitude towards ethics in animal and human research. Feedback was obtained from students and faculty to assess the outcome of this program. RESULTS: On analyzing the knowledge gained post intervention in 130 students, it was observed that in the post test for the items on ethics committee- need and composition, principles of research ethics was answered correctly by more number of students, which was statistically significant. The statistically significant positive change was observed for attitude of these students towards both animal and human research ethics. Case based discussions provided better understanding of ethical practices and its importance in conducting research as responded by majority students and faculty. CONCLUSIONS: Educational program on research ethics enhanced learning and brought about the positive attitudinal change. Majority students' and faculty appreciated the program and considered it as relevant for undergraduate training.

Safety of hydroxychloroquine in healthcare workers for COVID-19 prophylaxis.

BACKGROUND & OBJECTIVES: Hydroxychloroquine (HCQ), reported to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in in vitro studies, has been recommended for prophylaxis of COVID-19 in healthcare workers (HCWs). The objective of this study was to assess short-term adverse events (AEs) of HCQ in HCWs. METHODS: This cross-sectional study among consenting HCWs taking prophylaxis and working in hospitals with COVID-19 patients used online forms to collect details of HCWs, comorbidities, prophylactic drugs used and AEs after the first dose of HCQ. Verification of dose and AEs was done by personal contact. Multivariate logistic regression analysis was done to determine the effect of age, gender and dose of HCQ on AE. RESULTS: Of the 1303 HCWs included, 98.4 per cent (n=1282) took HCQ and 66 per cent (n=861) took 800 mg as first day's dose. Among the 19.9 per cent (n=259) reporting AEs, 1.5 per cent (n=20) took treatment for AE, none were hospitalized and three discontinued HCQ. Gastrointestinal AEs were the most common (172, 13.2%), with less in older [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.89], with more in females (OR 2.46, 95% CI 1.78-3.38) and in those taking a total dose of 800 mg on day one compared to a lower dose. Hypoglycaemia (1.1%, n=14), cardiovascular events (0.7%, n=9) and other AEs were minimal. INTERPRETATION & CONCLUSIONS: HCQ prophylaxis first dose was well tolerated among HCWs as evidenced by a low discontinuation. For adverse effects, a small number required treatment, and none required hospitalization. The study had limitations of convenience sampling and lack of laboratory and electrocardiography confirmation of AEs.

A prospective, randomized, placebo-controlled, double-blind comparative pilot study to evaluate the efficacy of Chlorophytum borivilianum on physical performance.

OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum (CB) on physical performance when exposed to accustomed activity (AA) and unaccustomed activity (UA) and the effect of CB on heart rate (HR) and blood pressure (BP) in the presence of UA and the effect on muscle strength in comparison with placebo. MATERIALS AND METHODS: A placebo-controlled, double-blind clinical study was initiated after ethics committee approval in healthy volunteers with fixed-dose regimen. Consented volunteers (n = 60) were assigned randomly into two groups of study drug (3 g/day) or placebo (3 g/day) for 2 months. They were evaluated at days 0, 30, and 60 with physical stressors (6-min walk test [6MWT] - distance, HR, and BP; 6-min exercise test [6ETC] - distance, maximum and average speed; and fixed workload test [FWT] - systolic BP, diastolic BP [DBP], and HR on cycle ergometer) and Jammar's dynamometer test for handgrip strength test on each visit. RESULTS: In 6MWT in CB group, distance on day 30 (456 ± 42.1) and day 60 (468.3 ± 0.4) was significantly increased when compared with day 30 (422.6 ± 45.7) and day 60 (419.6 ± 45.1) of the placebo group. On day 60, distance in 6ETC in CB group was 2.92 ± 0.6 which was significantly more than that of placebo group 2.4 ± 0.6. On day 60, in FWT, DBP in the CB group was 75.8 ± 4.4 which was significantly low compared to the placebo group 82.4 ± 7.4 (P < 0.05). CONCLUSION: CB increased physical performance when exposed to AA even after one month and in case of UA increase in performance was seen when CB was administered for two months thus validating its adaptogenic (anti-stress) potential.

Evaluation of oral multi-herbal preparation of Dashmoolarishta on mice model of osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is a chronic progressive disease commonly affecting the hip and knee joints. Although synthetic drugs are available and afford symptomatic relief, their side effects pose limitations to their continuous use. So, this research was focused on extracting drugs from indigenous medicinal plants that could have a beneficial effect on osteoarthritis. Dashmoolarishta is one such preparation whose effects have never been studied in comparison with recent drugs like hyaluronic acid (HA), hence this particular study was undertaken. The aim of this study was to evaluate the effects of Dashmoolarishta compared with HA on joint pathology and pain behavior in monosodiumiodoacetate (MIA)-induced OA in experimental mice. METHODS: The study was initiated after obtaining permission from the Animal Ethics Committee. This study was based on the MIA model of osteoarthritis, with mice being divided into five groups viz.: disease control (DC), Dasahmoolarishta high dose (HD) and low dose (LD), sham control (SC) and HA. The OA of the knee joint was induced in these mice using monosodiumiodoacetate. Seven days after induction, animals were subjected to weekly behavioral tests, daily oral Dashmoolarishta, and biweekly HA administration from weeks 2-4. At the end of the 4th week, histopathological examination of the knee joints was done. RESULTS: DC showed significant osteoarthritic changes. At week 4, the behavioral tests and histopathology results of all groups were found to be significant. A significant difference (p<0.05) was found between DC vs. SC, HA, HD, LD for open field test, Rota rod test, knee joint diameter, and Cat walk test. Dashmoolarishta HD and LD showed significant improvement in pain, as assessed by behavioral tests (p<0.05) and pathology, as assessed by knee joint histopathology (p<0.05). CONCLUSIONS: Oral Dashmoolarishta showed reduction in pain and disease activity in MIA-induced osteoarthritis in mice model.

Intra-articular injections of ketamine and 25% dextrose improve clinical and pathological outcomes in the monosodium iodoacetate model of osteoarthritis.

BACKGROUND: The study evaluated the effect of intra-articular injections of ketamine and 25% dextrose with triamcinolone acetate (TA) and hyaluronic acid (HA) on joint pathology and pain behavior in monosodium iodoacetate (MIA)-induced osteoarthritis (OA) in experimental mice. METHODS: In phase I, the MIA-induced OA model was standardized. In phase II, mice were divided into three groups: disease controls (DC), ketamine 12 mg/kg (K12) and ketamine 24 mg/kg (K24) to select an effective dose of ketamine for phase III. In phase III, the groups were: DC, normal controls (NC), K24, 25% dextrose (D25) - 10 µL, TA 6 mg/kg, and HA - 3.5 mg/kg. The effect of ketamine was compared with the standard drugs - TA and HA. In phases II and III, after 7 days following the induction of OA, animals were subjected to weekly behavioral tests and biweekly drug administration from week 2 to week 4. Subsequently, after 4 weeks knee joint samples were collected and sent for histopathological evaluation to a veterinary pathologist. RESULTS: In phase I, the DC group showed significant OA changes as compared to NC on knee joint histopathology scoring. In phase II, all the behavioral tests and knee joint histopathology results demonstrated a significant improvement with K24 as compared to DC. In phase III, significant differences were found between DC vs. HA, DC vs. D25, DC vs. K24, K24 vs. TA, HA vs. TA for open field test and hot plate test (p<0.001), whereas HA and ketamine showed comparable results for these tests. There was a significant improvement in D25, TA and K24, HA groups as compared to DC in histopathology scores, (p<0.05). CONCLUSIONS: The NMDA antagonist effect of ketamine and the proliferative effect of 25% dextrose showed a reduction in pain and disease activity in the OA model.

Development of collateral vessels: A new paradigm in CAM angiogenesis model.

The chorioallantoic membrane (CAM) assay is one of the most widely used models to study angiogenesis. In this study, collateral vessel development is reported in CAM assay useful in analysis of angiogenesis. Four days old white Leghorn fertilized chicken eggs were inoculated with vehicle, standard or test angiogenesis inhibitor using standard protocol. Central vessel growth was seen tapering down and collateral vessels were developed from the lower side of the chorioallantoic membrane moving upward in 12 days old standard or test treated CAMs. In the absence of the central vessel, collateral blood supply helped in survival of embryos. Hence, development of collateral vessels was used for ranking of blood vessels and angiogenesis in addition to well-known standard parameters related to central vessel. The finding could differentiate molecules inhibiting angiogenesis with or without collateralization which is crucial in anti-angiogenic therapy used for cardiovascular diseases and cancer. This study proposes a new avenue to distinguish pro-angiogenic molecules from anti-angiogenic ones as well as anti-angiogenic molecules which may or may not support alternative vascularization pathway that would have great impact on future angiogenic and anti-angiogenic therapy.

Development of active learning modules in pharmacology for small group teaching.

BACKGROUND: Current teaching in pharmacology in undergraduate medical curriculum in India is primarily drug centered and stresses imparting factual knowledge rather than on pharmacotherapeutic skills. These skills would be better developed through active learning by the students. Hence modules that will encourage active learning were developed and compared with traditional methods within the Seth GS Medical College, Mumbai. METHODS: After Institutional Review Board approval, 90 second year undergraduate medical students who consented were randomized into six sub-groups, each with 15 students. Pre-test was administered. The three sub-groups were taught a topic using active learning modules (active learning groups), which included problems on case scenarios, critical appraisal of prescriptions and drug identification. The remaining three sub-groups were taught the same topic in a conventional tutorial mode (tutorial learning groups). There was crossover for the second topic. Performance was assessed using post-test. Questionnaires with Likert-scaled items were used to assess feedback on teaching technique, student interaction and group dynamics. RESULTS: The active and tutorial learning groups differed significantly in their post-test scores (11.3 ± 1.9 and 15.9 ± 2.7, respectively, P < 0.05). In students' feedback, 69/90 students had perceived the active learning session as interactive (vs. 37/90 students in tutorial group) and enhanced their understanding vs. 56/90 in tutorial group), aroused intellectual curiosity (47/90 students of active learning group vs. 30/90 in tutorial group) and provoked self-learning (41/90 active learning group vs. 14/90 in tutorial group). Sixty-four students in the active learning group felt that questioning each other helped in understanding the topic, which was the experience of 25/90 students in tutorial group. Nevertheless, students (55/90) preferred tutorial mode of learning to help them score better in their examinations. DISCUSSION: In this study, students preferred an active learning environment, though to pass examinations, they preferred the tutorial mode of teaching. Further efforts are required to explore the effects on learning of introducing similar modules for other topics.

Evaluation of prakrti and quality-of-life in patients with irritable bowel syndrome.

OBJECTIVE: To evaluate the prakrti of irritable bowel syndrome (IBS) patients and its association with IBS subtypes and quality-of-life (QOL). METHODOLOGY: IBS patients with the consistent subtype in the last 6 months were recruited. Prakrti assessment with a 24-item questionnaire was performed and depending on the scores the patients were categorized into vata predominant, pitta predominant, and kapha predominant prakrti. QOL was assessed with prevalidated disease-specific 34-item questionnaire scored on a 0-100 scale. RESULTS: Of 50 IBS patients enrolled, with mean age of 43.5 ± 12.8 years, and male: female as 43:7, 22 patients were of vata and pitta predominant prakrti each while six patients had kapha predominant prakrti. IBS-C was diagnosed in 24 patients, IBS-D in 21, and IBS-M in five patients. In vata predominant group, IBS-C was found in 13 patients, IBS-D in 8, and IBS-M in 1. In pitta predominant group, IBS-D was found in 13, IBS-C in 6, and IBS-M in 3. In kapha predominant group, IBS-C was found in 5 patients and IBS-M in 1. The median QOL in IBS-C group was 48.897, IBS-D was 38.97, and IBS-M was 66.911. The median QOL score 52.205, 42.27, and 55.51 in vata, pitta, and kapha predominant group, respectively. CONCLUSION: Majority of the vata predominant patients had developed IBS-C, pitta predominant patients had developed IBS-D. QOL was better in pitta predominant individuals of all IBS-disease subtypes. With this, we find that prakrti examination in IBS helps in detecting the proneness of developing an IBS subtype and predicting their QOL accordingly.

Evaluation of effects of Mandurabhasma on structural and functional integrity of small intestine in comparison with ferrous sulfate using an experimental model of iron deficiency anemia.

BACKGROUND: The present study was planned to assess effects of Mandurabhasma (MB) on structural and functional integrity of small intestine using an animal model of iron deficiency anemia (IDA) in rat. METHODS: IDA was induced by giving iron deficient diet and retro-orbital bloodletting for 21 days in Wistar female rats. Rats (n = 72) were divided into six groups: (i) Control group, (ii) IDA rats, (iii) IDA rats receiving vehicle, (iv) rats receiving ferrous sulfate (40 mg/kg), (vi) rats receiving a low dose (22.5 mg/kg) of MB, (vi) rats receiving a high dose (45 mg/kg) of MB. Treatment was conducted for a period of 21 days followed by an assessment of change in hemoglobin (Hb) levels, lactase levels, lipid peroxidation activity by measuring malondialdehyde (MDA) levels and jejunal morphometry. RESULTS: In the present study, the lactase activity was markedly reduced in iron-deficient rats. Our study has demonstrated that intestinal morphology and MDA levels were not altered in the animals with IDA as compared to normal animals. In phase II, improvement in Hb response to ferrous sulfate was accompanied by an improvement in lactase activity. However, it significantly increased MDA levels with derangement of the normal villous structure. Rats receiving a low dose of MB did not have increased MDA levels. It did not alter the jejunal villous structure and improved lactase activity, but hematinic activity was found to be less than that of ferrous sulfate. Rats receiving a high dose of MB showed significantly improved Hb as well as lactase levels. They exhibited damage to the villous structure and increased MDA levels, but the effects were significantly less as compared to ferrous sulfate group. CONCLUSION: Rats receiving a high dose of MB have shown improvement in hematinic and lactase levels comparable to those receiving ferrous sulfate. However, it causes lesser oxidative damage as compared to ferrous sulfate. This is an encouraging finding because it indicates the potential of MB to cause lesser gastrointestinal side effects compared to ferrous sulfate.

Effect of Jyotismati seed oil on spatial and fear memory using scopolamine induced amnesia in mice.

BACKGROUND: Treatment of memory impairment associated with dementia such as Alzheimer's disease is still inadequate and requires development of new drugs. OBJECTIVE: The objective was to evaluate the memory enhancing effect of Celastrus paniculatus seed oil. MATERIALS AND METHODS: C. paniculatus seed oil was mixed with equal amount of pure ghee and administered orally to mice in the dose of 200 mg/kg/day. Piracetam was used as a standard nootropic. Elevated plus maze and passive avoidance tests were used as a models to test spatial and fear memory respectively. Scopolamine (3 mg/kg, i.p.), was used as an amnestic agent. RESULTS: Mice receiving C. paniculatus showed significant memory enhancement as compared to scopolamine group. The effect of C. paniculatus and combination of C. paniculatus with piracetam was comparable to that with piracetam alone. CONCLUSION: The present study demonstrates that C. paniculatus seed oil has memory enhancing effect and hence can be developed as a potential drug in the treatment of dementia.

Experimental evaluation of analgesic, anti-inflammatory and anti-platelet potential of Dashamoola.

BACKGROUND: Dashamoola, in the form of arishta and kwath, is a commonly used classical Ayurvedic multi-ingredient formulation for management of pain, arthritis and inflammatory disorders. OBJECTIVE: To study analgesic, anti-inflammatory and anti-platelet activity of Dashamoola and its combination with aspirin. MATERIALS AND METHODS: Wistar albino rats (180-200 g) and Swiss albino mice (20-25 g) of either sex were divided randomly into five groups: Distilled water, aspirin (500mg/kg in rats; 722.2 mg/kg in mice), Dashamoolarishta (1.8 mL/kg in rats; 2.5 mL/kg in mice) and Dashamoolarishta with aspirin. Anti-inflammatory activity was measured by change in paw volume in carrageenan-induced inflammation, protein content in model of peritonitis and granuloma weight in cotton pellet granuloma. Analgesic effect was evaluated by counting number of writhes in writhing model. Maximum platelet aggregation and percentage inhibition of ADP and collagen-induced platelet aggregation were estimated in vitro. Statistical analysis was done using one way ANOVA (post hoc Tukey's test) and P < 0.05 was considered significant. RESULTS: Dashamoolarishta and its combination with aspirin showed significantly (P < 0.01) less number of writhes. It showed significant (P < 0.001) anti-inflammatory activity by paw edema reduction in rats, decrease in proteins in peritoneal fluid (P < 0.001) and decrease in granuloma weight (P < 0.05) as compared to respective vehicle control groups. Dashamoola kwath alone and in combination with aspirin inhibited maximum platelet aggregation and percent inhibition of platelets as compared to vehicle (P < 0.001). CONCLUSION: Dashamoola formulation alone and its combination with aspirin showed comparable anti-inflammatory, analgesic and anti-platelet effects to aspirin.

Effect of Tinospora cordifolia on physical and cardiovascular performance induced by physical stress in healthy human volunteers.

INTRODUCTION: In Ayurveda Tinospora cordifolia (Willd.) Miers., has been used for its Rasayana, Deepana, Jwaranashana, Tridosha Shamaka properties. It is an immunomodulator, useful in stress, hyperlipidemia, pyrexia. T. cordifolia was evaluated for adaptogenic activity in healthy volunteers during exercise. AIMS: The primary objective of this study was to evaluate the effect of T. cordifolia on physical performance, and secondary objectives were to evaluate muscle power, maximal oxygen consumption, and sympathetic activity in comparison with placebo when subjected to physical stress. MATERIALS AND METHODS: A total of thirty participants were randomly assigned into three groups (n = 10 each) namely placebo, TC 150 and TC 300. Placebo group received maize starch capsule, TC 150 and TC 300 received 150 mg and 300 mg, respectively of T. cordifolia aqueous extract in capsule form once daily in the morning for 28 days. The assessment was performed at baseline visit, day 14 and 28. Physical stressors were cycle ergometer exercise, Jammer's hand-held dynamometer, and cold pressor tests. Physical performance evaluated was maximum distance and speed, oxygen consumption (VO2 max), and hand grip strength. Cardiovascular response was assessed by multiple heart rate (HR) and blood pressure (BP) measurements during each test. RESULTS: On day 28, TC 150 mg group showed a significant increase in mean maximum speed compared to placebo. On day 14 and 28, TC 300 mg group showed a significant decrease in mean systolic BP (SBP) and HR on fixed workload exercise compared to placebo. There was significant increasing dose effect of both TC groups on SBP on day 14 and 28 and on HR on day 28 only. On day 14 and 28, TC 300 mg showed a significant decrease in mean HR on the cold pressor test, compared to placebo. CONCLUSION: T. cordifolia improved physical performance and suppressed over activation of the sympathetic nervous system showing its adaptogenic property.

Efficacy and safety of a polyherbal formulation in hemorrhoids.

BACKGROUND: The medical management of hemorrhoids should include an integrated approach. This integrated approach can be achieved by polyherbal formulations containing anti-inflammatory, styptics, analgesics, and laxative effect which reduce inflammation, pain, and bleeding, and increase gastro-intestinal motility and soften stools. One such polyherbal kit is "Arshkeyt™, a 7 day kit," which consists of oral tablets and powder along with topical cream. OBJECTIVE: Efficacy and safety of Arshkeyt™, a 7 day kit, a marketed polyherbal formulation was evaluated in comparison with conventional therapy practiced in surgery outpatient departments. MATERIALS AND METHODS: Patients (n = 90) with hemorrhoids were randomly allocated to receive either Arshkeyt™ or standard therapy (combination of oral Isabgul powder and 2% lidocaine gel) for 14 days. Assessment on the basis of rectal symptoms and proctoscopic examination was done on day 0, 7, and 14 to derive a "composite score" which ranged from 0 to 25 by a blinded evaluator. The primary endpoint was number of patients achieving composite score 0 at the end of therapy (day 14). Inter-group analysis was done using Chi-square test. RESULTS: On day 14, the composite score of 0 was achieved in 15 patients of Arshkeyt™ group versus 6 patients receiving standard therapy. The symptoms and signs which showed significant improvement in Arshkeyt™ group compared to standard treatment group were the tenesmus (visual analog score) score (P = 0.047), anal sphincter spasm (P = 0.0495) and a decrease in the grade of hemorrhoids (P = 0.0205) on day 14. Arshkeyt™ was also more beneficial in case of bleeding hemorrhoids as compared to nonbleeding hemorrhoids (P < 0.05). The incidence of adverse drug reactions in both groups was comparable and no patient required any treatment for the same. CONCLUSION: "Arshkeyt™, a 7 day kit," was effective in the treatment of hemorrhoids and had a good safety profile.

Effect of Saraswatarishta in animal models of behavior despair.

BACKGROUND: Saraswatarishta (SA) is a herbo-mineral formulation consisting of 18 plants some of which are Medhyarasayanas. It has been claimed to be useful in treating central nervous system disorders. OBJECTIVE: To evaluate antidepressant effect of 'Saraswatarishta'(SA) alone and in combination with imipramine and fluoxetine in animal models of depression. MATERIALS AND METHODS: After obtaining IAEC permission, 144 rats (n = 36/part) were randomized into 6 groups- Group 1: Distilled water (1 mL), Group 2: Imipramine (30 mg/kg), Group 3: Fluoxetine (10 mg/kg), Group 4: SA (1.8 mL/kg), Group 5: Imipramine + SA, Group 6: Fluoxetine + SA. Effects of study drugs were evaluated in forced swim test (FST) with single exposure to FST (Part 1) and repeated exposure for 14 days (Part 2). In Part 3, reserpine was used with FST and effects of study drugs were evaluated against single exposure to FST. Same model was used with repeated exposures to FST (Part 4). In each part, rats were subjected to open field test (OFT) for 5 min prior to final FST. The variables measured: Immobility time in FST; line crossing, rearing and defecation in the OFT. RESULTS: In all four parts, individual drugs and combinations thereof produced significant decrease in immobility time as compared to control, and extent of decrease was comparable amongst these groups. However, values for combination of fluoxetine with SA group were found to be lesser than that for individual agents in Parts 2 and 3. Combination of SA with imipramine did not enhance its anti-depressant effect in any of the parts. OFT findings did not vary significantly amongst the study groups. CONCLUSION: Decreased immobility in FST and absence of generalized stimulation or depression of motor activity in OFT point towards potential antidepressant effect of Saraswatarishta. Its co-administration with fluoxetine showed more promising effects.

Effect of combination of Phyllanthus emblica, Tinospora cordifolia, and Ocimum sanctum on spatial learning and memory in rats.

BACKGROUND: There has been a steady rise in number of patients suffering from dementia including dementia associated with Alzheimer's disease. Effective treatment of Alzheimer's disease dementia is an unmet medical need. OBJECTIVE: To evaluate effects of formulation containing combination of Phyllanthus emblica (Pe) and Tinospora cordifolia (Tc) with and without Ocimum sanctum (Os) on learning and memory performance of normal and memory impaired rats in complex maze and compare with effects of Tinospora cordifolia and Phyllanthus emblica alone. MATERIALS AND METHODS: Wistar rats; either sex (100-150 g) were divided in seven groups Control, Piracetam, Rivastigmine, Tc, Pe, Formulation 1 (Tc + Pe), and Formulation 2 (Tc + Pe + Os). The study was divided in four parts: In part 1 memory enhancement was tested in normal rats. In part 2, 3, and 4 the effects of drugs were tested in Scopolamine-, Diazepam-, and Cyclosporine-induced amnesia. Hebb-Williams maze was used to test for learning and memory. Time required to trace food and number of errors in maze were noted. RESULTS: In normal rats, all test drugs showed significant reduction in time required to trace the food and number of errors after 24 h compared with vehicle control. Formulations 1 and 2 reduced the time required to trace food and number of errors and the results were comparable with positive control groups and comparators Tc and Pe. Formulations 1 and 2 reversed amnesia produced by Scopolamine, Diazepam, and Cyclosporine when compared with vehicle control and showed comparable results with those of positive control groups and comparators Tc and Pe. CONCLUSION: Formulations 1 and 2 demonstrated nootropic activity and both the formulations showed comparable nootropic activity with that of Tc and Pe alone.

Introduction of case based teaching to impart rational pharmacotherapy skills in undergraduate medical students.

OBJECTIVE: The aim of this study is to assess the impact of case based teaching (CBT) on learning rational prescribing and to compare CBT with the traditional method of teaching (TRD). MATERIALS AND METHODS: Second year Bachelor of Medicine and Bachelor of Surgery (MBBS) students (n = 179) were administered a pre-test and randomly divided into groups to receive CBT (n = 96) and TRD (n = 83). CBT group was further sub-divided into CBT1 and CBT2. Both these groups were taught two topics each by CBT and TRD during tutorials; however, the topics were switched with respect to method of teaching. The post-test comprised of three therapeutic problems of which two were related, and one was not related to the tutorial topics. Marks obtained in the post-test were graded and analysed using Fischer's exact test. RESULTS: In the post-test, the therapeutic problems on diabetes mellitus and peptic ulcer were attempted by 85.41% students from CBT and 73.49% from TRD group. CBT group obtained more marks for these problems (4.23 ± 0.94; P < 0.001) than the TRD (3.32 ± 0.92) group. Also, more students in the CBT obtained grade 3 (P < 0.001) and fewer obtained grade 1 (P < 0.01), compared to the TRD group. When the grades of the two CBT groups were compared, it was found that fewer students in CBT 2 had obtained grade 1 and those scoring higher grades were comparable between the two groups. For the therapeutic problem on malaria, 7.29% students from CBT and 18.07% from TRD received 0 grade (P < 0.05). More students received ≥ 2 grade in CBT group (P < 0.05). CONCLUSION: Use of CBT during tutorials is better than TRD and facilitates learning of rational pharmacotherapy.

Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers.

Ashwagandha (Withania somnifera) (WS), a "rasayana" drug, is recommended for balavardhan and mamsavardhan. The study was intended to evaluate dose-related tolerability, safety, and activity of WS formulation in normal individuals. The design was prospective, open-labeled, variable doses in volunteers. Eighteen apparently healthy volunteers (12M:6F, age:18-30 years, and BMI: 19-30) were enrolled. After baseline investigations, they received WS capsules (Rx) (aqueous extract, 8:1) daily in two divided doses with increase in daily dosage every 10 days for 30 days (750 mg/day ×10 days, 1 000 mg/day × 10 days, 1 250 mg/day × 10 days). Volunteers were assessed for symptoms/signs, vital functions, hematological and biochemical organ function tests. Muscle activity was measured by hand grip strength, quadriceps strength, and back extensor force. Exercise tolerance was determined using cycle ergometry. Lean body weight and fat% were computed from skin fold thickness measurement. Adverse events were recorded, as volunteered by the subjects. Repeated measures ANOVA, McNemar's test, and paired t test were employed. All but one volunteer tolerated WS without any adverse event. One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest dose and was withdrawn from study. In six subjects, improvement in quality of sleep was found. Organ function tests were in normal range before and after the intervention. Reduction in total- and LDL- cholesterol and increase of strength in muscle activity was significant. Total body fat percentage showed a reduction trend. WS, in escalated dose, was tolerated well. The formulation appeared safe and strengthened muscle activity. In view of its traditional Rasayana use, further studies are planned to evaluate potential of this drug in patients of sarcopenia.