Comparative efficacy of Sat-i Gilo and metformin hydrochloride in the management of Type 2 diabetes mellitus: a randomized controlled trial

Abstract

Introduction

Type 2 Diabetes Mellitus (T2DM) is a global health concern with rising prevalence and significant morbidity and mortality due to associated microvascular and macrovascular complications. Unani medicine offers a rich repository of natural remedies for metabolic disorders, with Sat-i-Gilo (a traditional aqueous extract of Tinospora cordifolia) being a prominent example known for its antihyperglycemic, antioxidant, and immunomodulatory properties. The aim of this study was to compare the efficacy of Sat-i Gilo with metformin hydrochloride in managing T2DM.

Methods

In this open-label randomized controlled trial, 40 participants with T2DM successfully completed the study duration. The intervention group received Sat-i Gilo 1g twice daily for 3 months, and the control group received metformin hydrochloride 500 mg twice daily for the same duration. Primary outcome measures included changes in hemoglobin A1C (HbA1c) and estimated average glucose (eAG) levels, measured before and after treatment. Secondary outcomes comprised changes in fasting blood sugar (FBS) and postprandial blood sugar (PPBS), assessed at baseline and at every second follow-up visit. Additionally, diabetes-specific quality of life was evaluated using the diabetes quality of life (DQoL) questionnaire at baseline and post-treatment.

Results

The trial results showed a mean difference of −0.22 (95 %CI: −0.52, 0.08, p = 0.154, d = 0.45) in HbA1c levels and −6.23 (95 %CI: −14.81, 2.35, p = 0.150, d = 0.47) in eAG levels between the intervention and control groups at the end of the study.

Conclusion

The findings of this study suggest that Sat-i Gilo may provide beneficial effects in the management of T2DM. While no statistically significant difference was observed between Sat-i Gilo and metformin in terms of glycemic outcomes, these results support the possibility of comparable efficacy under the conditions of this study. Further large-scale, rigorously designed clinical trials are recommended to validate these findings and to explore the long-term effectiveness and safety of Sat-i Gilo.