Vidangadi Lauha’ for Obese Type 2 Diabetes mellitus; Randomised controlled clinical study

Abstract Background Type 2 diabetes mellitus in obese persons is becoming alarming due to the increasing prevalence of its microvascular and macro vascular complications. Multitargeted treatment can be considered better than single targeted treatment in view of multiple pathways involved in the pathogenesis of diabetes and its complications.Methodology-This open-label randomised controlled clinical study aimed to evaluate the clinical efficacy of ‘Vidangadi Lauha’ (an Ayurveda formulation) in comparison with metformin for obese type II diabetes mellitus. Participants were divided into two groups. The trial group received Vidangadi Lauha 5 gm BID, and the control group received tablet metformin 500 mg BID for a duration of 3 months.Results- Among 550 screened participants, 120 participants were eligible; out of them, 100 participants were enrolled and randomised by a computer-generated method, and of them, 80 patients (40 in each group) completed the trial. Vidangadi Lauha showed a reduction in HbA1c from 8.048 (0.95) to 7.14 (0.73), while metformin showed a reduction in HbA1C from 8.3 (0.99) to 7.18 (0.67).Conclusion-Both treatments were equally effective in reducing blood sugar fasting (F), postmeal (PM) glycated haemoglobin (HbA1C) and body mass index (BMI). Vidangadi Lauha is more effective in reducing Ayurvedic symptoms, waist hip ratio and cholesterol than metformin. High-density lipoproteins (HDLs) were improved by minor clinical differences in both groups. Neither treatment had a statistically significant effect on reducing low-density lipoproteins (LDL).