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

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 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 measures were 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 were 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 Trikgudmet and Met groups, respectively. This study may provide "a new evidence for use of Trikgud as an add-on therapy for uncontrolled T2DM patients with metformin monotherapy in context of Nepal.