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
Exclusion criteria
|
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)" |
Notes |