Corroboration of the ethno pharmacological use of a standardized ayurvedic polyherbal formulation in type-2 diabetic patients; a pilot clinical study

Scientific validation of ethno-medicines and their use as therapeutic intervention in the management of chronic diseases like diabetes can provide more effective and less toxic drugs. The aim of this randomized pilot clinical study was to evaluate the safety and therapeutic efficacy of Polyherbal Formulation (PHF) in comparison to Metformin in newly diagnosed type-2 diabetic patients. 46 Patients, newly diagnosed with Type-2 diabetes mellitus (T2DM) were included in the study and randomized into 2 sex, age and BMI matched groups, Group 1 was administered with PHF (2-3 g/day) and group 2 received Metformin (0.5-1.5 g/day) for a period of 16 weeks. Fasting blood glucose (FBG) and post prandial blood glucose (PPBG) was measured every week and glycosylated hemoglobin (HbA1c) was measured before and after 3 months. 16 weeks treatment with PHF significantly reduced the PPBG by 20 % relative to 18 % decrease in Metformin. Significant improvement in blood glucose level was also depicted by the reduction in FBG and HbA1c in PHF group, compared to the baseline values. PHF is well tolerated, and the study confirms its antidiabetic activity by reducing the blood glucose in T2DM patients. A larger study is warranted for its use as an adjunctive therapy.