In order to highlight the role of indigenous methods for prevention of diabetes, Research Society for Study of Diabetes in India (RSSDI), an association of Diabetologists in India, is planning to conduct a three-year national multi-centric study on 1,500 border line diabetics from across the country.
Approved by ClinicalTrials.gov, a service of the US National Institutes of Health which provides database of publicly and privately supported clinical studies of human participants conducted globally, the study would be conducted from five diabetes centres in the country located at University College of Medical Sciences, Delhi under Dr Madhu SV; Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry under Dr A K Das; Nizam's Institute of Medical Sciences (NIMS), Hyderabad under Dr PV Rao; Center for Diabetes and Endocrine Care, Bengaluru under Prof KM Prasanna Kumar; and Diabetes Endocrine Nutrition Management and Research Centre (DENMARC), Mumbai under Dr Hemraj Chandalia.
Estimated to cost Rs.2 crore, the study would select 300 participants between 20 and 70 years of age in each centre on the basis of recruitment process from amongst the borderline diabetics.
Speaking about the study, Dr Hemraj Chandalia, Diabetologist at DENMARC and Jaslok Hospital said, “Study will involve following a conventional diet, exercise, yoga and consumption of 10 to 15 gms of fenugreek (methi) powder. There will be no medication involved in the study. Study will entail constant monitoring of diet regimen of the candidates with periodic tests every three months for three years. This will help us determine the rate of conversion from borderline diabetics to diabetics.”
Information on www.ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally registered with the Web site when they begin, and the information on the site is updated throughout the study. ClinicalTrials.gov includes information about medical studies in human volunteers. Most of the records in ClinicalTrials.gov describe clinical trials (also called interventional studies). The site was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA).