Efficacy of integrated Ayurveda treatment protocol in uncontrolled type 2 diabetes mellitus: A randomized controlled study

Introduction: Uncontrolled type 2 diabetes mellitus (T2DM), measured as glycated hemoglobin (HbA1C) of >7 %, is prevalent. An integrated Ayurveda treatment protocol (ITP) has potentially beneficial effects. This study aims to compare the efficacy of ITP with standard diabetic care in patients with uncontrolled T2DM. Methods: This was a randomized, controlled, open-label clinical study. The study included patients (n = 200) with uncontrolled T2DM, on metformin (Glucophage) >= 1000 mg/day. Patients were randomized to either the standard treatment protocol (STP) or ITP group. The intervention in STP group was metformin (Glucophage) >= 1000mg/day with diet and lifestyle measures, while ITP group received metformin (Glucophage) >= 1000 mg /day, madhumehari ghana tab (ayurveda medicine), ayurvedic diet, and yoga for 90 days. The primary endpoint was a change in HbA1C. Secondary endpoints were homeostatic model assessment for insulin resistance (HOMA IR), fasting insulin, fasting blood glucose (FBG), postprandial blood glucose (PPBG), weight, body mass index (BMI), waist circumference, lipid profile, diabetes quality of life (DQOL), hemoglobin, and serum creatinine. Result: Outcome difference assessment revealed significant improvement in HbA1C in ITP group compared with STP group (mean difference:1.04, 95 % confidence interval [CI]:1.27 to -0.80). ITP showed significant changes when compared to STP in HOMA IR (mean difference:1.41, 95 % CI:2.40 to -0.42), FBG (mean difference:22.25, 95 % CI:42.10 to -14.97), PPBG (-52.27, 95 % CI:70.50 to -34.05), serum triglycerides (mean difference:25.21, 95 % CI:42.30 to -8.12), and DQOL (mean difference:21.88, 95 % CI: 26.83 to -16.92). Furthermore, ITP group also demonstrated significant results in weight, BMI, body fat, visceral fat percentage, and body surface area. Comparable results were observed in serum insulin, total cholesterol, very low-density lipoprotein, and serum creatinine in between the groups. Changes were not significant for hemoglobin %, high-density lipoprotein, and low-density lipoprotein in both groups. There were mild adverse events in both groups, with 8 in STP group and 4 in ITP group. Conclusion: ITP intervention produced significant improvements in glycemic parameters, insulin resistance parameters, anthropometric measures, and quality of life compared to standard care in uncontrolled T2DM.