Open Labeled Randomized Controlled Clinical Trial on Impaired Glucose Tolerance Munneerizhuvu

Abstract

To evaluate the efficacy of Thiripala Chooranam Tablet (T.TPC) in reversal of Impaired Glucose Tolerance (IGT) through Clinical and Preclinical methods, the null hypothesis stated was TPC will not stop progression of IGT to Diabetic. This study is a pioneer in nature aimed to test the efficacy of T.TPC in Pre-diabetes through Clinical trial. The Trial drug was prepared using Thiripala Chooranam with its decoction as excipient is an innovative idea employed here. The tablet prepared matched the PLIM standards. The drugs used were authenticated by Pharmacognosy Department, SCRI. Physico-chemical and Phytochemical testing was done as per the guidelines. The results revealed that the drug is pure and is free from heavy metals, aflatoxins and microbial load. Pharmacognosy results approved the presence of Polysaccharides. The drug exhibited satisfactory results in inhibition of two glycosidic enzymes namely alpha amylase and alpha glycosidase. The FTIR analysis carried out on the trial drug indicated that there was no chemical interaction between Thiripala Chooranam tablet and excipients, suitability of the excipients in the formulation also tested. The outcome measures were reduction in blood glucose parameters and reversal of IGT which was well observed with administration of TPC tablets. Further the trial drug was helpful in reducing the Serum cholesterol levels. The risk of progression to type 2 diabetes is hence well controlled by intake of TPC tablets. Improved the QALY is expected in subjects with reduced disease burden. CONCLUSION: The Clinical and Pre-clinical studies conducted disproved the null hypothesis and proved the efficacy of the trial drug, TPC tablet to be a good hypoglycaemic, hypolipidemic and antioxidant which is able to not only treat but also reverse Pre-diabetes, risk of Diabetes and dyslipidaemia. Being a Kayakalpam, the trial drug can be used alongside Convention hypoglycaemic drugs in order to prevent future microvascular complications of Diabetes and hence reduce the disease burden of High risk population.