A 45-day randomized, open-label, comparator study to evaluate the safety and efficacy of zincovit tablets with grape seed extract (Nutritional food supplement) in patients with type 2 diabetes mellitus

Objective: To evaluate the efficacy of Zincovit (ZVT) tablets with grape seed extract (GSE) in patients with Type 2 diabetes mellitus by testing the hypothesis of a greater reduction in plasma glucose levels (fasting blood sugar[FBS] and post-prandial blood sugar [PPBS]) from baseline and after 45 days of therapy as compared to standard comparator. Methods: This was a randomized, open-label, comparative (2-arm), prospective 45 days study. Treatment consisted of 2 arms: Antidiabetic drug plus non-pharmacological measure alone or ZVT tablets with GSE plus non-pharmacological measures. A total of 30 patients (15 in each arm) were included in the study. Results: ZVT tablet did not alter the FBS, PPBS, and HbA1c level in diabetic patients compared to diabetic patients treated with placebo. No changes were seen in any of the safety parameters when given for 45 days. Conclusion: ZVT tablets do not possess antidiabetic activity in spite of good safety profile in our study design. This could be due to several limitations of the study such as inadequate sample size, short duration of the study, and wrong selection of the patients. A long-term, double-blind, placebo controlled study in a large sample of population measuring glycemic parameters, and cardiovascular outcomes could give a clear picture of the anti-diabetic effect of ZVT with GSE tablets.