A 12-week randomized, double-blind, placebo-controlled human clinical trial for the evaluation of safety and efficacy of Gymnema extract(Melitwocut®) in the management of Blood Sugar Levels in pre-diabetic individuals.

Diabetes mellitus (DM) is a metabolic disease, involving inappropriately elevated blood glucose levels. In India, there are estimated 77 million people above the age of 18 years are suffering from diabetes (type 2) and nearly 25 million are pre-diabetics (at a higher risk of developing diabetes in near future). More than half of the people are unaware of their diabetic status which leads to health complications if not detected and treated early. Gymnema sylvestre has long been valued in Ayurvedic medicine for its role in metabolic health, particularly in supporting blood sugar regulation. The extract, derived from its leaves, is rich in bioactive compounds, primarily gymnemic acids, which have been extensively studied for their ability to aid in glycaemic control and insulin function. To ensure the potency and efficacy of its active components, Gymnema extract is typically obtained through aqueous or ethanol-based extraction methods, preserving its beneficial properties. It is commercially available in various formulations, including powder, capsules, and liquid extracts, with many preparations standardized for gymnemic acid content to maintain consistency in therapeutic applications.