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

Abstract

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.