Double-blind, placebo-controlled clinical evaluation of an Ayurvedic formulation (GlucoCare capsules) in non-insulin dependent diabetes mellitus.

ABSTRACT

Diabetes mellitus describes a metabolic disorder of multiple etiologies characterized by insulin resistance, relative insulin deficiency and hyperglycemia with disturbances of carbohydrate, fat and protein metabolism. The goal for treatment of diabetes is to prevent its acute manifestations and long-term microvascular and macrovascular complications. The present study was conducted to evaluate the efficacy and safety of an Ayurvedic formulation (GlucoCare Capsules) in non-insulin dependent diabetes mellitus. Fifty NIDDM patients of pitta-kapha prakriti attending the outpatient department of the Government Ayurvedic Medical College, Guwahati, Assam, India were included in the study, and randomly divided into 2 groups, GlucoCare and placebo. All received either GlucoCare or placebo in a dose of 2 capsules twice daily, before meals for 3 months. All 50 patients completed the study - no drop outs, withdrawals or patients lost to follow up. The GlucoCare group showed significant improvement in symptoms from the 2nd month till the end of the study. GlucoCare was well tolerated by all patients throughout the treatment period with no evidence of adverse effects. The study indicates clinical efficacy of GlucoCare Capsules in the management of NIDDM in those belonging to pitta-kapha prakriti. The formulation is well tolerated and appears safe in the dosage used.