Kannan, M (2018) Open Labeled Randomized Controlled Clinical Trial on Impaired Glucose Tolerance – IGT (Munneerizhivu). Doctoral thesis, The Tamilnadu Dr. M.G.R. Medical University, Chennai.
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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 LC_MS analysis showed the presence of Gallic acid, Quercetin, dihydro Corilagin and Chebulinic acid. ICP-OES analysis revealed the presence of essential micro-nutrient in the trial drug. The Open clinical trial carried out helped in identification of T. TPC in reversing Prediabetes by reducing the blood glucose parameters of HbA1c, FBS and OGTT 2hours from Glucose intolerance to Glucose tolerance level. Apart from maintaining Normoglycemia during the follow up period, the drug significantly reduced Serum cholesterol levels (TC, TGL, LDL). The drug compliance was good and no adverse reactions were reported during the treatment period. After the follow up period of 1 month, all (except 2 subjects in the LTPC arm) had normal OGTT levels. Diabetes’ Risk prediction between the two groups by Responder analysis, Calculation of ARR, RRR and RR showed there is significant risk reduction in the LTPC arm by 71.2%, a notable measure. Siddhar’s intuition has once again been proved through this study in causation, prognosis and treatment of Munnerizhivu through concepts of Humoral (Vali, Azhal, Aiyam) pathology and body constitution (Udaliyal) assessment. 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 (Quality of Adjusted Life years) 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.
| Item Type: | Thesis (Doctoral) |
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| Uncontrolled Keywords: | Impaired Glucose Tolerance (IGT), Munneerizhivu, Open Labeled Randomized Controlled Clinical Trial. |
| Subjects: | AYUSH > Maruthuvam |
| Depositing User: | Subramani R |
| Date Deposited: | 25 Sep 2019 14:59 |
| Last Modified: | 24 Oct 2022 05:06 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/11574 |
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