'Vidangadi Lauha' for obese type 2 diabetes mellitus patients - An open-label randomized controlled clinical trial

Background: Type 2 diabetes mellitus in obese persons is becoming alarming due to the increasing prevalence of its microvascular and macrovascular complications. Multi-targeted treatment can be considered better than single-targeted treatment because of the multiple pathways involved in the pathogenesis of diabetes and its complications. Objective: The study aimed to evaluate the efficacy of 'Vidangadi Lauha' (VL) (an Ayurveda formulation) compared with Metformin for obese type II diabetes mellitus. Methodology: This is an open-label randomized controlled clinical study.Participants were divided into two groups. The trial Group received VL 5 gm BID, and the control group received tablet metformin (MT) 500 mg BID for three months. Results: VL showed reduction in HbA1c from 8.048(0.95) to 7.14(0.73), (CI, 0.7810 to 1.035; p < 0.0001) while MT showed reduction in HbA1C from 8.3(0.99) to7.18(0.67), (CI, 0.9220 to 1.305; p < 0.0001). VL showed improvement in the Quality of life instrument for the Indian Diabetes questionnaire(QOLID) score from 113.87 (11.36) to 136.47(8.703) (CI, -25.68 to -19.52; p < 0.0001) as compared to MT 128.57(7.9) to 102.32(7.9), (CI, 23.19 to 29.39; p < 0.0001) VL showed reduction in bowel symptom questionnaire 30.275(8.077) to 13.2 (1.265), (CI, 14.60-19.51; p < 0.0001) as compared to MT from 23.85(7.530) to 38.25(6.332), (CI, -15.99 to -12.80; p < 0.0001). Conclusion: Both treatments were equally effective in reducing blood sugar fasting (F), post-meal (PM) glycated hemoglobin (HbA1C), and body mass index (BMI). VL is more effective than MT in reducing Ayurvedic symptoms, waist-hip ratio, cholesterol, quality of life, and bowel symptom questionnaire score.