CTRI/2017/04/008384.

Trial name or title	Acronym: —
Methods	Type of trial: efficacy trial Allocation: randomised Intervention model: parallel Masking: open label Primary purpose: treatment
Participants	Condition: type 2 diabetes mellitus Enrolment: estimated 180 Inclusion criteria Patients of either gender with known T2DM Between 20 and 65 years of age Patients with borderline blood lipid abnormality and not taking any hypolipidaemic agents Patients on stable monotherapy of glimepiride 2 mg Patients willing to use plant‐based therapy (resveratrol) with gold standard therapy in management of T2DM Exclusion criteria Patients willing to use other anti‐oxidant supplementation rather than resveratrol Patients with type 1 diabetes Pregnant and lactating mothers Patients with dyslipidaemia and taking lipid‐lowering therapy including statin Patients with history of severe heart disease Patients with hepatic and renal dysfunction Patients taking/requiring beta‐blocker and any drug that produces hyperglycaemia or hypoglycaemia Patients with history of allergy to grapes and consuming alcohol daily
Interventions	Intervention(s): resveratrol supplement (1 g once daily for 12 months) Comparator(s): placebo
Outcomes	Primary outcome(s): change in blood sugar level (fasting and fed), lipid profile, and systolic blood pressure and diastolic blood pressure from baseline to end of study visit (12 months) Secondary outcome(s): change in blood sugar level (fasting and fed), lipid profile, haemoglobin A1c, and systolic and diastolic blood pressure
Starting date	Trial start date: September 2014 Trial completion date: not reported
Contact information	Responsible party/principal investigator: Hemant Mishra, Department of Medicine, Vikas Hospital, Kalyan West, Thane, Maharashtra, India
Study identifier	Trial identifier:CTRI/2017/04/008384 Trial registered retrospectively (registered on 20/04/2017)
Official title	A randomized, open‐label, active‐control, phase IV clinical study evaluating efficacy and safety of resveratrol as an adjuvant therapy in patients with diabetes, dyslipidemia and hypertension
Stated purpose of study	Quote: "a study to check whether addition of resveratrol is beneficial and safe in patients with diabetes, dyslipidemia and hypertension (who are already on standard therapy)"
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