A Pilot, Open-Label, Proof-of-Concept Study To Evaluate the Efficacy and Safety of Asthiposhak® Tablets in Participants Suffering From Asthikshaya or Osteopenia.

Introduction Both osteoporosis and osteopenia are prevalent public health concerns worldwide and can lead to debilitating bone fractures. This study aimed to assess the efficacy of Asthiposhak® Tablets in individuals with Asthikshaya (osteopenia) by measuring changes in the bone mineral density (BMD) score before and after the intervention, specifically between visit 1 (baseline) and visit 8 (after 180 days of treatment). Methods The single-arm study involved the screening of participants for Asthikshaya (osteopenia) using baseline investigations, which included a bone mineral density (BMD) assessment through a dual-energy X-ray absorptiometry (DEXA) scan. A total of 36 participants were enrolled in the study, who took two Asthiposhak Tablets three times a day with lukewarm water, for a period of 180 days. Safety assessments, along with evaluations of BMD (DEXA Scan), Ayurvedic Symptom Score, and serum biochemical markers, were conducted through blood investigations. Efficacy and safety data were analyzed using 'intention-to-treat' analysis. Descriptive statistics were used to express data in percentages, mean ± SD, or median (IQR). Data at different intervals were compared using paired t-tests or Wilcoxon signed-rank tests. One-way analysis of variance (ANOVA) with Bonferroni correction tested the significance between visits for the Ayurvedic Symptom Score, and Friedman's two-way analysis of variance by ranks measured differences in vital parameters. The significance level used was p<0.05. Results Out of the initially recruited 36 participants, 30 successfully completed the study, consisting of 12 males and 18 females, with an age range of 40 to 70 years and a mean age of 51.33 years. After 180 days of treatment with Asthiposhak Tablets, a statistically significant (p<0.05) improvement in hip and spine BMD (T-score) was observed. Additionally, significant reductions in the mean Total Ayurvedic Symptom Score were noted at both 90 and 180 days of treatment compared to day 0. Moreover, the levels of bone-specific alkaline phosphatase and osteocalcin, serum bone markers, showed statistically significant (p<0.05) reduction after 180 days of treatment compared to day 0. Importantly, all safety variables, including laboratory investigations, remained within the normal range following the 180-day treatment with Asthiposhak Tablets. Conclusion Asthiposhak Tablets exhibited significant efficacy in enhancing both BMD (T-score) and Ayurvedic Symptom Score, thereby substantiating their osteoprotective potential in individuals with Asthikshaya (osteopenia). Furthermore, the tablets were found to reduce the levels of biochemical markers, such as serum bone-specific alkaline phosphatase and osteocalcin, suggesting their anti-resorptive action.

A Pilot, Prospective, Randomized-Controlled Study to Evaluate the Efficacy and Safety of Arsha Hita™ in the Treatment of Anal Fissures.

Introduction Anal fissures are tears in the anal canal that cause pain, bleeding, and spasms. They can be treated with non-operative options such as sitz baths, local anesthetics, topical nitrates, oral fiber, and calcium channel blockers, but some patients require surgery. Topical nitrates have side effects such as severe headaches, while topical calcium channel blockers can cause itching. There is a need to explore alternative treatments with fewer side effects. This proof-of-concept pilot study aimed to compare the efficacy and safety of a combination of Arsha Hita™ tablets and ointment (Shree Dhootapapeshwar Limited, Mumbai Maharastra, India) (test treatment) with a combination of lidocaine 1.5% w/w + nifedipine 0.3% w/w cream for local application and Isabgol powder (6 g) orally as an active comparator (standard treatment), which is the standard treatment of anal fissures as per the Association of Colon and Rectal Surgeons of India (ACRSI) guidelines. Methodology This study was a single-center, prospective, randomized-controlled study conducted in Karnataka, India. Participants were screened for anal fissures and randomized to receive either standard treatment (Group A) or test treatment (Group B) for 14 days, and were re-evaluated after two, four, and six weeks. The study assessed signs and symptoms related to anal fissures, such as pain post-defecation on Visual Analog Scale (VAS), bleeding per anus grading, wound healing grade, stool consistency, and stool frequency. Compliance, inter-current illness, and concomitant therapy were noted at each visit. The study used independent sample t-tests to compare variables at baseline and chi-square or Fisher's exact tests to compare the number/proportion of participants achieving primary and secondary endpoints. Mann-Whitney U test was used to compare median composite scores at baseline and Visit 4, and Friedman's two-way analysis of variance was used to compare median composite scores across the four visits (p < 0.05 was considered significant). Descriptive analysis was used to assess VAS, bleeding, and healing grades. Results The study included 53 participants with anal fissures, of which 25 out of 27 allocated in Group A (two drop-outs) received standard treatment, and all 26 allocated in Group B received Arsha Hita treatment. At the end of the study, 11 participants in Group B achieved a 90% reduction in composite scores compared to only three patients in Group A (p<0.05). Both groups showed improvement in pain on defecation, severity of bleeding, healing of anal fissure wound, and participant's and physician's global impression score. Group B had significantly better results in terms of VAS score, resolution of per-anal bleeding, and physician's global impression score (p<0.05). There were no adverse events in either group during the six-week treatment period. Conclusion The pilot study provides evidence that the combination of Arsha Hita tablets and Arsha Hita ointment may be more effective and safer for treating anal fissures than the standard treatment. The test treatment group experienced greater pain relief, complete resolution of per-anal bleeding, and better global impression scores than the standard treatment group. These findings suggest the need for further research through larger, randomized controlled trials to determine the efficacy and safety of Arsha Hita in treating anal fissures.

An observational multi-centric COVID-19 sequelae study among health care workers.

Background: India has seen more than 43 million confirmed cases of COVID-19 as of April 2022, with a recovery rate of 98.8%, resulting in a large section of the population including the healthcare workers (HCWs), susceptible to develop post COVID sequelae. This study was carried out to assess the nature and prevalence of medical sequelae following COVID-19 infection, and risk factors, if any. Methods: This was an observational, multicenter cross-sectional study conducted at eight tertiary care centers. The consenting participants were HCWs between 12 and 52 weeks post discharge after COVID-19 infection. Data on demographics, medical history, clinical features of COVID-19 and various symptoms of COVID sequelae was collected through specific questionnaire. Finding: Mean age of the 679 eligible participants was 31.49 ± 9.54 years. The overall prevalence of COVID sequelae was 30.34%, with fatigue (11.5%) being the most common followed by insomnia (8.5%), difficulty in breathing during activity (6%) and pain in joints (5%). The odds of having any sequelae were significantly higher among participants who had moderate to severe COVID-19 (OR 6.51; 95% CI 3.46-12.23) and lower among males (OR 0.55; 95% CI 0.39-0.76). Besides these, other predictors for having sequelae were age (≥45 years), presence of any comorbidity (especially hypertension and asthma), category of HCW (non-doctors vs doctors) and hospitalisation due to COVID-19. Interpretation: Approximately one-third of the participants experienced COVID sequelae. Severity of COVID illness, female gender, advanced age, co-morbidity were significant risk factors for COVID sequelae. Funding: This work is a part of Indian Council for Medical Research (ICMR)- Rational Use of Medicines network. No additional financial support was received from ICMR to carry out the work, for study materials, medical writing, and APC.

Evaluation of Antidepressant Effect of Minocycline in Alcohol Abstinence-Induced Depression Model in Mice.

Introduction Depression is one of the common comorbidities seen in chronic alcohol use disorder. Also, alcohol withdrawal induces depression and anxiety, which is associated with relapse in alcohol consumption. Minocycline, a tetracycline derivative, has shown an antidepressant effect in preclinical models. However, their effect on alcohol withdrawal-induced depression has not been studied. Therefore, the current study has been undertaken to evaluate the effect of minocycline on alcohol abstinence-induced depression models in mice. Method We conducted the study in two models. C57bl/6 mice were given a two-bottle choice (alcohol + water) for 28 days. During alcohol abstinence of 14 days, mice were treated with 10 mg/kg, 30 mg/kg, and 50 mg/kg of minocycline and were evaluated for behavioral changes using the forced swim test (FST) and tail suspension test (TST). A sucrose preference test was carried out where mice were exposed to binge alcohol drinking protocol for 12 days, where a two-bottle choice (alcohol or water) was given. This was followed by exposing the mice to a two-bottle choice paradigm (alcohol + sucrose) and they were divided into groups - no treatment group, vehicle-treated, minocycline 30 mg/kg or minocycline 50 mg/kg treated - and consumption of sucrose was assessed. Result In the forced swim test, a significant decrease in immobility time (p<0.05) was observed in the high-dose minocycline group (82.75±19.09) as compared to the vehicle control group (128.12±35.44). In the tail suspension test also, a significant decrease in immobility time (p<0.05) was seen in the high-dose minocycline group (83.75±18.61) as compared to the vehicle control group (122.25±18.51). The water and alcohol intake were comparable among all groups. In the sucrose preference test, it was found that the minocycline 50 mg/kg group had the highest sucrose preference (55%) followed by the minocycline 30 mg/kg group (50%) as compared to 42% in the vehicle control group. Significant reduction in brain-derived neurotrophic factor (BDNF) levels was seen with minocycline 50 mg/kg (p<0.05) and minocycline 30 mg/kg group (p<0.05) in BDNF levels when compared to the normal control group. Conclusion Minocycline in a higher dose (50 mg/kg) has shown an effect in alcohol withdrawal-induced depression in the abstinence-induced two-bottle choice model in mice. Both doses of minocycline have shown an effect in the sucrose preference test in the alcohol withdrawal-induced depression model.

Antipsychotic Drug Utilization and Adverse Drug Reaction Profiling in Patients With Schizophrenia at a Tertiary Care Hospital in Western India.

Introduction Prescription pattern studies conducted in patients with schizophrenia have shown variability in the utilization of antipsychotics based on the geographical location of the study setting. Moreover, there is only a sparse number of studies specifically related to adverse drug reactions (ADRs) in schizophrenia. Hence, a need was felt to study the antipsychotic utilization pattern and adverse drug reactions in patients with schizophrenia in our setting. Methods This was a cross-sectional, observational study conducted at the psychiatry outpatient department (OPD) of a tertiary care hospital in India. Patients diagnosed to have schizophrenia as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) were included in the study provided they had been prescribed antipsychotic medications at the study center for at least three months. The sociodemographic profile of the patients and caregivers was recorded, and prescription pattern assessment was done using WHO core drug use indicators. Information related to ADRs was recorded, and further assessment was done based on the causality, severity, and preventability of ADRs. Results A total of 250 patients were enrolled in the study. Risperidone (40.25%) and olanzapine (26.32%) were the most commonly prescribed antipsychotic drugs, while trihexyphenidyl was the most frequently prescribed concomitant medication. Among the 37 cases of adverse drug reactions that were recorded, amenorrhea, sedation, and weight gain were found to be the most common. The majority of ADRs were of mild severity in addition to being non-preventable. Conclusion It was observed that atypical antipsychotics were commonly prescribed in the study center, and the majority of the ADRs were mild and not preventable, which shows the adequacy of prescribing practices in the current setting.

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.

Payment for participation in clinical research: Review of proposals submitted to the ethics committees.

OBJECTIVE: In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment. METHOD: This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained. RESULTS: Of the 73 studies requiring payment, 89.04% were interventional and 10.96% observational. Reimbursement of travel expenses (60%) was the major reason for payment followed by inconvenience due to participation, loss of wages and time spent. The queries raised by EC in more than 50 % of studies were related to informing patients about the payment in the informed consent document. The investigators complied with the EC requirements regarding payment (15/21) and the remaining provided explanations. The median amount of payment in pharmaceutical sponsored studies was higher compared to investigator initiated studies. Higher payments were approved by ECs on case to case basis in a few studies. The ECs did not have any policy/ standard operating procedure for payment practices. CONCLUSION: The present study first of its kind in India, demonstrated that quantum of payment was not uniform for pharmaceutical sponsored and investigator initiated studies and payments were not considered for majority of observational studies. Travel reimbursement was the most common reason for payment. There is a need to develop guidelines for determining appropriate payment/incentives to participants for specific types of research related activities.

Minocycline in Alcohol Withdrawal Induced Anxiety and Alcohol Relapse in Rats.

INTRODUCTION: Anxiety and negative sensations due to alcohol withdrawal are factors leading to alcohol relapse and addiction. Minocycline, an antibiotic, can decrease alcohol consumption in rats, however, its effects on alcohol withdrawal anxiety and relapse have not been studied. MATERIAL AND METHODS: Part 1: Forced alcohol drinking in gradually increasing concentration was administered till day 22 in rats. Effect of drugs on anxiety was assessed using elevated plus maze (EPM) and two-chambered box apparatus, after removal of alcohol. Part 2: For relapse, an alcohol deprivation effect model was used, rats were continuously offered alcohol and water for 4 consecutive weeks in a two-bottle choice paradigm, followed by 2 weeks of alcohol deprivation. Effect of drugs on alcohol consumption during the first hour of alcohol reintroduction was assessed. Animals were sacrificed and whole brain Tumor Necrosis Factor (TNF) α was estimated. RESULTS: Part 1: Anxiety at 3 hours was significantly lower following minocycline (20 mg/kg i.p.) or diazepam compared to vehicle control. Part 2: Acute administration of minocycline (5,10 and 20 mg/kg, i.p.) suppressed alcohol consumption significantly (p value<0.05) as compared to vehicle control. A significant decrease in whole brain TNF α was observed in animals treated with minocycline compared to untreated animals. CONCLUSION: Minocycline attenuates alcohol withdrawal anxiety and disrupts alcohol relapse.

Prescription pattern and awareness of disease and treatment in patients of Parkinson's disease.

AIM: This cross-sectional study aimed to evaluate the prescription pattern, awareness of disease and treatment in patients with Parkinson's disease (PD). MATERIALS & METHODS: A total of 100 PD patients, attending a tertiary care hospital in Mumbai were included. Prescriptions were analyzed and awareness was evaluated using a questionnaire. RESULTS: The mean number of anti-Parkinson agents (APA) prescribed was 1.52 ± 0.65. Number of APA strongly correlated with disease duration (ρ = 0.818; p < 0.001). Many APA were underutilized (prescribed daily dose/defined daily dose < 1). There was no awareness of all items on symptoms and alternative therapeutic options. Awareness of disease impairments (32%), long-term complications (28%), dosing regimen (46%) and follow-up (36%) was poor. CONCLUSION: More than one APA is commonly prescribed in PD patients. Awareness of disease and treatment of PD is poor among the patients.

Evaluation of effect of minocycline on rewarding potential and alcohol relapse in place preference model in mice.

INTRODUCTION: Medical management for alcohol abuse has limitations. Alcohol consumption activates N-methyl-d-aspartate receptors and release of nitric oxide which can be inhibited by minocycline as it readily crosses blood brain barrier and may have effect on alcohol consumption. Thus, study objective is to evaluate the effect of minocycline on rewarding property, extinction and the reinstatement phenomenon induced by alcohol in a model of conditioned place preference (CPP) in mice. METHODOLOGY: To evaluate rewarding effects of alcohol, CPP procedure consisted of 4 parts, including adaptation (day 1), pre-conditioning test (day 2), conditionings with alcohol (days 3, 5, 7 and 9) or saline (days 4, 6, 8 and 10) and postconditioning test (day 11) conducted on 11 consecutive days. The groups included were saline treated group (alcohol control), naltrexone - 1mg/kg (positive control), and minocycline in the doses of 10, 30 and 50mg/kg. To evaluate the effect of minocycline on alcohol relapse, CPP procedure consisted 6 parts, the first 4 were the same as enumerated above followed by extinction (days 12-16) and reinstatement phase (day 17). RESULTS: The time spent in alcohol paired compartment by different groups, revealed that minocycline and naltrexone significantly attenuated alcohol-induced place preference compared to alcohol control (p<0.05). Pretreatment with minocycline and naltrexone blocked reinstatement of extinguished CPP. CONCLUSION: Minocycline may have a role in attenuating the rewarding property of alcohol and prevent alcohol relapse.

Evaluation of performance of the Medical Research Department in 'Research naive' non-academic hospital: An audit.

INTRODUCTION: Conducting medical research is not limited to academia and pharmaceutical industry but even multispeciality hospitals need to venture in this area along with patient care. To develop research culture among well-established non-acedemic hospital is always difficult and challenging task. This article attempts to evaluate the performance of the department in 'Research naïve' hospital in the last two years and review the strengths and challenges it faced at each step. METHODS: This was a retrospective document analysis study evaluating the steps towards setting and sustaining of Medical Research Department of Bhaktivedanta Hospital during the period of January 2013 to June 2015 (30 Months). The authors developed a checklist (along with performance indicators) to assess the Preparatory phase and Activity phase of the research department which were evaluated by Institute Quality Management Team. Each step of both phases was also reviewed in terms of strengths and challenges as perceived by the authors. RESULTS: During 2 year journey of research naïve Hospital, Institute had witnessed Hospital initiated (n=24, 59%) and sponsored projects (n=17, 41%) in all specialties. HRC reviewed (n=2.13) projects per meeting for administrative consideration while IEC reviewed (n=2.15) projects for scientific and ethical review. Challenges during preparatory phases were circumvent by immense cooperation of hospital management for initial investment, sensitization through research workshops for consultants, established procedures and trained support manpower and constant encouragement by research coordinator. CONCLUSION: Considering evaluation of 41 studies in very first 2 years in 'Research naive non academic institute demonstrated successful implementation of trio model of Hospital Research Committee for administrative review, IEC for scientific-ethical review, centralized MRD for coordinating all research projects under one roof which may act as role model for Research naive institutes.

Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.

A cross-sectional study to assess the incompatible dietary behavior of patients suffering from skin diseases: A pilot study.

BACKGROUND: Ayurveda implies the importance of diet and dietary habits in various human diseases. Confirmatory evidence regarding role of diet and dietary practices in diseases of skin are lacking. OBJECTIVES: To assess incompatible dietary behavior in acne, psoriasis, fungal infections, and vitiligo patients using a questionnaire tool. MATERIALS AND METHODS: A questionnaire-based, cross-sectional case control study was conducted in the skin out-patient department of a tertiary care hospital. Patients were enrolled in each diseased group and their control groups. Perception of patients regarding the role of diet in skin diseases was evaluated. Study participants were subjected to 2 validated questionnaires to assess consumption of incompatible diet and incompatible dietary habits. RESULTS: Diet was perceived to be more important in patients of acne compared to their controls (P < 0.05). Mean composite score regarding the assessment of consumption of incompatible diet of acne (19.594 ± 4.613 vs. 16.719 ± 3.457, P = 0.006) and psoriasis (17.531 ± 2.688 vs. 16.281 ± 2.630, P = 0.0497) patients was higher than their controls. Mean composite score regarding assessment of incompatible dietary habits was higher in acne (19.031 ± 4.589 vs. 15.688 ± 4.645, P = 0.0054), psoriasis (18.875 ± 5.014 vs. 15 ± 3.069, P = 0.0009), and fungal infection (16.469 ± 3.538 vs. 14.5 ± 2.627, P = 0.0115) patients compared to controls. Mean composite scores of both the questionnaires in vitiligo patients were similar to controls. CONCLUSION: Scores for consumption of incompatible diet and dietary habits were found to be higher in acne and psoriasis patients compared to controls. Patients with fungal infections had higher scores for the presence of incompatible dietary habits but similar scores for the consumption of incompatible diet, whereas both scores in patients of vitiligo were similar to controls.

Serious Adverse Events Reports: Analysis and Outcome of Review by an Institutional Ethics Committee of a Tertiary Care Hospital in Mumbai, India.

The Indian regulations for clinical trials were amended in January 2013 regarding reporting time lines, relatedness, and compensation for Serious Adverse Events (SAEs). Our study assessed the extent of regulatory compliance in reporting SAEs to the Institutional Ethics Committee (IEC) over 4 years (January 2009-January 2013) before and 18 months after (February 2013-July 2014) the amended regulations. SAE reports were studied retrospectively for reporting time lines, relatedness, compensation, and IEC response before and after the law revision. Before 2013 had 89/160 (55.6%) SAEs reports submitted late while in the after period, only 2/11 reports were delayed (18%). In the before period, 26 SAE reports mentioned "relatedness" of which only 15 (57.6%) stated about compensation. After 2013, all the 9 non-death reports were complete. The IEC took median 17 days to respond before 2013, while after 2013 responded within 5 days. Thus, there was poor compliance in terms of SAE reporting time lines before the revision of the law.

An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

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.

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.