Evaluation on Safety and Efficacy of A Polyherbal Antidiabetic Nutraceutical Formulation

In the present study, the polyherbal antidiabetic nutraceutical formulation was screened for its safety and efficacy using albino wistar rats (130-150gm). The formulation consists of Gymnema sylvestre, Trigonella foenum-graecum, Allium cepa, Curcuma longa, Phyllanthus amarus, Tinospora cordifolia, Eugenia jambolana, Cinnamomum zeylanicum. The safety of the formulation was studied by acute toxicity studies according to Organisation for Economic Co-operation and Development (OECD) guidelines and efficacy was studied by using streptozotocin induced diabetes model at 45 mg/kg b.w. The test drug did not show any signs of toxic­ity or mortality up to 5000 mg/kg which was fixed as the cut off point for the maximum tolerated dose.  Antidiabetic activity was screened in streptozotocin induced diabetic rat model for 21 days using glibenclamide 1.5 mg/kg as standard and parameters like blood glucose level and weight variation were studied. After 21 days treatment the mean blood glucose level of the formulation, dose 1 (500mg/kg) treated group showed 142.50±1.11mg/dl, the formulation, dose 2 (250mg/kg) treated group showed 210.66±2.96 mg/dl, the standard group showed 137.66±2.10 mg/dl, Control group 433.33±9.89mg/dl, Normal group 94.83±0.30 mg/dl respectively and at a dose of 500mg/kg body weight. The formulation showed significant increase in the body weight. Therefore, the results indicated that the polyherbal neutraceuticals formulation is an efficacious and safer antidiabetic/ oral hypoglycemic formulation in Type II diabetes.