A Randomized, Double-Blind, Placebo-Controlled Trial of an Ayurvedic Herbal Formulation and Vitamin C/E on Vascular Function in Patients with Cardiovascular Disease.

Background and

Objectives

Cardiovascular disease (CVD) is the leading cause of death globally. The World Health Organization has called for investigations into traditional systems of medicine for CVD prevention. Ayurveda includes a classical herbal formulation called Maharishi Amrit Kalash (MAK) traditionally used for disease prevention, health promotion and healthy aging. The study objective was to evaluate MAK effects on biomarkers of vascular function and structure compared to vitamin C and E supplementation in a high CVD risk population. Materials and

Methods

In this double-blind randomized controlled trial, 138 Black men and women (mean age 65 ± 7 years) with established CVD or high CVD risk were assigned to either MAK (n = 46), vitamin C/E (n = 46), or placebo (n = 46) for 12 months. The primary outcomes were change in brachial artery reactivity testing (BART) with flow-mediated dilation (FMD, endothelium-dependent) and nitroglycerin-mediated dilation (NMD, endothelium-independent). Other outcomes included carotid intima-media thickness (cIMT), blood pressure, and serum lipids. ANCOVA and pairwise comparisons were performed.

Results

After 12 months of intervention, the MAK group demonstrated significant improvement in BART-NMD compared to placebo (mean change + 4.18% vs. +2.95%, p = 0.018) and numerical but non-significant improvement compared to the +3.32% mean change for the Vitamin C/E group (p = NS). There were no significant group differences for BART-FMD, cIMT, blood pressure, and lipids. Intervention compliance ranged from 70-80%.

Conclusions

In this randomized controlled trial, 12 months of MAK supplementation improved endothelium-independent vascular smooth muscle function (BART-NMD) in Black adults at high CVD risk. The MAK group achieved a mean BART-NMD of approximately 15.6%, reaching the established threshold for normal vascular smooth muscle function. This selective improvement in smooth muscle responsiveness without changes in endothelial function, vascular structure, or conventional risk factors suggests MAK may influence specific pathways relevant to vascular aging. Larger studies with clinical outcomes are needed to further evaluate this effect on cardiovascular health in aging and high-risk populations.