A Randomized Double-Blind Placebo-Controlled Multicentric Clinical Trial of an Ayurvedic Intervention, Varadi Kwatha Ghana Vati, as an Adjunct vs Treatment as Usual in the Management of Type-2 Diabetes Mellitus: A Study Protocol

Why clinicians should know about it

• Picked for Complementary and Alternative Medicine (paper of the day, 18 July 2026): Recent Complementary and Alternative Medicine research from a high-quartile journal.
• Picked for Nephrology (paper of the day, 18 July 2026).

Abstract

BACKGROUND: Diabetes mellitus is a major and growing contributor to morbidity and mortality. Indian Council of Medical Research-India Diabetes study reports a prevalence of 11.4% for diabetes and 15.3% for prediabetes in India. Diabetes is described in depth in ancient Ayurveda texts, from aetiology to pre-clinical, clinical features, complications, and its stage-wise management. The current study has the potential to explore whether lowering glycemic control at the level of haemoglobin affects endogenous insulin production by examining C-peptide and insulin levels. METHODS: The current study is designed as a randomized, double-blind, placebo-controlled, multicenter, two-arm clinical trial enrolling 220 participants across two Indian sites. Adults with diagnosed Type-2 diabetes mellitus on oral hypoglycemic agents (OHAs) with glycated haemoglobin (HbA1c) between 8% and 10% will be randomized (1:1) to receive either an Ayurvedic Formulation, Varadi Kwath Ghana Vati, or a matched placebo, administered twice daily after meals as an adjunct to standard OHAs therapy for 180 days. The primary outcome is the mean change in HbA1c from baseline to 90 and 180 days. Secondary outcomes include the proportion of participants achieving optimal glycemic control, i.e., HbA1c ≤7%; changes in fasting C-peptide, fasting insulin, lipid profile, liver function tests, and renal function tests at baseline, 90, and 180 days. Treatment effects will be estimated as between-group differences in mean changes ± standard deviation (SD), reported with 95% confidence intervals, with statistical significance set at p < .05. DISCUSSION: Following the lead from the classical anti-diabetic action of Varadi Kwath ingredients, i.e., Haritaki (Terminalia chebula Retz), Bibhitaki [Terminalia bellirica (Gaertn.) Roxb.], Amalaki (Phyllanthus emblica L.), Daruharidra (Berberis aristata DC.), Musta (Cyperus rotundus L.), and Devdaru (Cedrus deodara Roxb. Ex D.Don). The drug will be evaluated through HbA1c and the indigenous production of C-peptide and insulin through the study. TRIAL REGISTRATION: CTRI/2026/01/100208, Registered on: 02/01/2026, Registered Prospectively. © 2026 Wiley Periodicals LLC.

Abstract as published, via PubMed.