Protocol outlines randomized trial of Varadi Kwath Ghana Vati as adjunct therapy for Type-2 Diabetes Mellitus
Background
Globally, Type-2 Diabetes Mellitus (T2DM) is a significant and growing contributor to morbidity and mortality, with India reporting a high prevalence of 11.4% for diabetes and 15.3% for prediabetes. Traditional Ayurvedic texts extensively describe diabetes, covering its etiology, clinical features, complications, and stage-wise management. Despite existing treatments, there's a continuous need to explore interventions that can improve glycemic control and potentially influence endogenous insulin production, as measured by C-peptide and insulin levels, offering a complementary approach to standard care.
Study Design
This randomized, double-blind, placebo-controlled, multicenter, two-arm clinical trial plans to enroll 220 adult participants with diagnosed Type-2 Diabetes Mellitus (T2DM) on oral hypoglycemic agents (OHAs) and HbA1c between 8% and 10%. Participants will be randomized (1:1) to receive either Varadi Kwath Ghana Vati or a matched placebo, administered twice daily after meals as an adjunct to OHAs for 180 days. Primary endpoint: mean change in HbA1c from baseline to 90 and 180 days.
Why It Matters
If successful, this trial could provide evidence-based validation for an Ayurvedic intervention as a valuable adjunct in Type-2 Diabetes Mellitus management, particularly in regions where traditional medicine is widely practiced. A positive outcome could offer a new, potentially well-tolerated, and accessible treatment option for patients struggling to achieve optimal glycemic control with conventional OHAs alone. Furthermore, by examining changes in C-peptide and insulin levels, the study aims to shed light on whether improved HbA1c is linked to enhanced endogenous insulin production, offering insights into its mechanism of action and potentially informing future combination protocols.
type-2-diabetes
ayurveda
clinical-trial
hba1c
glycemic-control
adjunct-therapy