Evaluation of Withania somnifera (L.) Dunal (Ashwagandha) on Physical Performance, Biomarkers of Inflammation, and Muscle Status in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Study.

Background: Sarcopenia is associated with chronic inflammation, a sedentary lifestyle, and ageing. However, there exists no drug, which is safe and effective for long-term use. Ashwagandha ( (L.

Evaluation of Effect of Montelukast in the Model of Streptozotocin Induced Diabetic Nephropathy in Rats.

Background: Diabetic nephropathy is a progressive condition and a leading cause of end-stage renal disease. Oxidative stress and inflammation play an important role in its pathogenesis. In pre-clinical studies, Montelukast had shown renoprotective and anti-oxidant properties, hence the study was planned to evaluate the effect of Montelukast in a Streptozotocin (STZ) induced model of diabetic nephropathy.

A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective.

Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken.

Diverse therapeutic developments for post-traumatic stress disorder (PTSD) indicate common mechanisms of memory modulation.

Post-traumatic stress disorder (PTSD), characterized by abnormally persistent and distressing memories, is a chronic debilitating condition in need of new treatment options. Current treatment guidelines recommend psychotherapy as first line management with only two drugs, sertraline and paroxetine, approved by U.S.

Use of Topical Steroids in Dermatology: A Questionnaire Based Study.

Context: Topical steroids, the most widely prescribed drugs in dermatology are being increasingly misused.

Aims: This study was conducted to assess knowledge and practices regarding the use of topical steroids and to analyze prescriptions containing topical steroids.

Subjects And Methods: Following approval from the institutional ethics committee, participants were recruited as per the selection criteria and divided into those treated in the institution and those having outside prescription.

A review of clinical studies involving pregnant women registered in the Clinical Trials Registry of India.

Context And Aims: Pregnant women undergo physiological changes which influence the efficacy as well as safety of medications used. Very few drugs are tested and approved for medical conditions during pregnancy, and less pharmacokinetic data are available to form clinical treatment guidelines. There was no data available regarding the type of research studies conducted in pregnancy in India.

Reports of site monitoring visits by institutional ethics committees in an Indian tertiary care hospital: A retrospective analysis.

The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring.

Current Status of Delamanid in the Management of MDR Tuberculosis.

Delamanid is a nitro-dihydro-imidazooxazole compound which was developed by a Japanese company, Otsuka Holdings inc. and has shown in-vitro and in-vivo activity against drug resistant tuberculosis. The drug exerts its anti-mycobacterial activity by inhibition of mycolic acid biosynthesis, leading to defective cell wall formation ultimately leading to bacterial death.

Effect of montelukast in experimental model of Parkinson's disease.

Despite the availability of many drugs offering symptomatic relief in Parkinson's disease, there are no drugs available offering neuroprotective effect. Hence, it was decided to evaluate the neuroprotective effect of montelukast, an anti-inflammatory drug, in rotenone induced model of Parkinson's disease in rats. Forty eight male wistar rats were randomly divided into three groups.

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.

Drug Utilization in Neonatal Intensive Care Unit of a Tertiary-care Hospital in Mumbai, India.

Objective: To study the prescription pattern (using applicable WHO indicators), cost analysis and off-label use of drugs in neonatal intensive care unit (NICU) of a tertiary-care hospital.

Methods: The prescriptions of 460 neonates admitted to a NICU during July 2014-March 2015 were studied prospectively.

Results: Of 460 neonates, 54.

Ethics Committees in India: Past, present and future.

Unlabelled: Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual.

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.

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.

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.

Effect of Jyotiṣmatī 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.

Role of dopamine--D2 receptor in spatial memory retention and retrieval determined using Hebb-Williams complex maze.

Effects of bromocriptine and sulpiride were observed on encoding and retrieval of spatial memory in Wistar rats using Hebb-Williams complex maze. Rat was placed in entry chamber and allowed to reach reward chamber. Ten trials were given each day per rat for 3 consecutive days.

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.

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.

Animal models of erectile dysfunction.

Animal models have contributed to a great extent to understanding and advancement in the field of sexual medicine. Many current medical and surgical therapies in sexual medicine have been tried based on these animal models. Extensive literature search revealed that the compiled information is limited.

Perceptions and experiences of community members serving on institutional review boards: a questionnaire based study.

The community representative plays a very important role in an institutional review board (IRB) but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire (Cohen's kappa coefficient of 0.