Factors Influencing Pregnant Women's Participation in Randomised ClinicalTrials in India: A Qualitative Study. To explore factors affecting participation of pregnant women in randomised clinical trials in Belagavi, Karnataka, India. A qualitative study using semi-structured in-depth interviews and focus group discussions as data collection methods. Primary, secondary and tertiary health
Representation from India in multinational, interventional, phase 2 or 3 trials registered in ClinicalTrials Registry-India: A cross-sectional study. In multinational trials that have run in India, we wished to determine whether there was too much (60% or higher) recruitment from India. We downloaded all trial records from ClinicalTrials Registry-India, CTRI, and stored them in a local SQLite
Oral D-methionine protects against cisplatin-induced hearing loss in humans: phase 2 randomized clinicaltrial in India. This exploratory Phase 2 clinical trial is the first determining safety and efficacy of oral D-methionine (D-met) in reducing cisplatin-induced ototoxicity. Randomised parallel double-blind placebo-controlled exploratory Phase 2 study. Fifty adult cancer patients received
Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinicaltrial in India. Evaluate and compare contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA) in married lactating women (20-35 years) using the progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD
Nurse-Delivered Screening and Brief Intervention Among College Students with Hazardous Alcohol Use: A Double-Blind Randomized ClinicalTrial from India. To determine the effectiveness of individual-based, nurse-delivered, on-campus screening and brief intervention (SBI) for hazardous alcohol use among college students. It was a parallel-design, double-blind, randomized controlled trial. Out
Regulatory requirements for clinicaltrials in India: What academicians need to know The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based
Regulatory developments in the conduct of clinicaltrials in India There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs
A 51-week, open-label clinicaltrial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis. To assess the efficacy and safety of pancreatin (pancrelipase) enteric-coated minimicrospheres (MMS) over a one-year period in patients with pancreatic exocrine insufficiency (PEI) due
of registries; 23 are listed in ClinicalTrials.gov, 11 in the Iranian Registry of Clinical Trials, 11 in the Chinese Clinical Trials Registry, two in the Cuban Public Registry of Clinical Trials (RPCEC), and one each in the EU Clinical Trials Register, the ClinicalTrials Registry—India, and the ISRCTN Registry.Seven are triple- or quadruple-masked and two are single-masked (investigator or outcomes assessor
, 2.66-8.43) scores than did those in the control group. Multidomain interventions during preconception, pregnancy and early childhood led to modest improvements in child neurodevelopment at 24 months. Such interventions for enhancing children's development warrant further evaluation. ClinicalTrials Registry-India CTRI/2017/06/008908.
with the ClinicalTrial Registry India, CTRI/2021/01/030233, is closed to accrual, and this is the final data analysis. Between Feb 9, 2021, and May 30, 2023, 356 patients were pre-screened for eligibility, of whom 275 patients were enrolled and randomly assigned (134 to the 2·5 mg olanzapine group and 141 to the 10·0 mg olanzapine group). 267 patients (132 in the 2·5 mg group and 135 in the 10·0 mg group) were
and barriers to implementing it in the management of schizophrenia. The study has been registered with the ClinicalTrials Registry-India (CTRI/2023/08/056210).