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Efficacy and safety of Trikgudas an add-on medicine in uncontrolled type 2 diabetes mellitus (T2DM) patients with metformin monotherapy: A randomized controlled trial


International Journal of Complementary & Alternative Medicine
Amit Man Joshi,1Ram Adhar Yadav,1Sirjana Shrestha,2Jitendra Shrestha,1Puneshwar Keshari3

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Abstract

Metformin is quite effective in managing Type 2 diabetes mellitus (T2DM). Studies have reported that the combined use of oral hypoglycemic medicines is prescribed in uncontrolled T2DM metformin monotherapy. So, we aim to evaluate the efficacy and safety of Ayurvedic herbo-mineral formulation (Trikgud) in managing uncontrolled T2DM with metformin monotherapy in Nepalese population. This study was a randomized, double-blind, and controlled trial. A total of 56 participants with the diagnosis of T2DM were randomly assigned to the intervention group (Trikgudmet) or control (Met) group in a ratio of 1:1 for 12weeks. The primary outcome measure was was the difference in the change in glycated haemoglobulin (HbA1C), fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (2-h PPG) between the groups, and secondary outcome measures was the change in body mass index (BMI), waist-hip ratio (WHR), lipid profile, liver function tests and renal function tests between the baseline and at 12weeks after intervention. At week 12, there were significant differences of FPG and 2-h PPG in both Trikgudmet group and Met group when compared with week 0. There was a statistically significant decrease of 8.6% and 10.1% of HbA1C levels in Trikgumet and Met groups, respectively.  This study may provide new evidence for use of Trikgudas an add-on therapy for uncontrolled T2DM patients with metformin monotherapy in context of Nepal.

Keywords

SEAR, southeast asia region, IDF, international diabetes federation, T2DM, Type 2 diabetes mellitus, FBG, fasting blood sugar, STZ, streptozotocin, PPG, post prandial blood glucose, HbA1c, glycosylated hemoglobin, NARTC, national ayurveda research and training center, FPG, fasting plasma glucose, 2-h PPG, 2-h plasma glucose, OGTT, oral glucose tolerance test, RPG, random plasma glucose, API, ayurvedic pharmacopoeia of India, ALT, alanine aminotransferase, AST, aspartate aminotransferase, HDL, high-density lipoprotein, LDL, low-density lipoprotein, BMI, body mass index, WC, waist circumference, WHR, waist-hip ratio, SPSS, statistical package for the social sciences

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