Clinical Utility and Safety of Coccinia grandis Extract in Patients with Newly Diagnosed Type 2 Diabetes Mellitus

Abstract

Preclinical studies (in vitro and in vivo) have demonstrated the antidiabetic effect of the aqueous leaf extract of Coccinia granids (Linn.) Voigt (Cucurbitaceae). This study determined the clinical utility and safety of the herbal capsule of C. grandis (HCC), which consisted freeze dried powder of the hot water extract of C. grandis leaves, in patients with newly diagnosed type 2 diabetes mellitus (DM). Newly diagnosed type 2 DM patients (n=158), belonging to age group of 30-60 years, were recruited for three months long double blind, randomized, placebo controlled clinical trial. Patients with known hyperlipidemia, hypertension, renal, liver, cardiac, respiratory, thyroid, psychiatric and any other chronic or acute diseases, and pregnant women were excluded. Recruited patients were randomized into two groups (1:1 ratio) either to receive HCC (500 mg/day) or placebo capsules of corn starch (500 mg/day). Percentage of glycated hemoglobin (HbA1C %), fasting plasma glucose (FPG) concentration, insulin and homeostatic model assessment for insulin resistance (HOMA-IR), serum concentration of fructosamine and safety parameters were estimated at the base line and at the end of the intervention. Intention-to-treat analysis, the “gold standard” for analyzing data of clinical trials, was performed.