NCT07206901

Evaluation of an Ayurvedic Herbal Compound Compared to Vitamins C+E and Placebo on Vascular Function in High-Risk Subjects

Evaluation of an Ayurvedic Herbal Compound (Maharishi Amrit Kalash) Compared to Vitamins C+E and Placebo on Vascular Function in High CVD Risk Subjects: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Maharishi International University · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized controlled trial aimed to evaluate the effects of an herbal Ayurvedic herbal supplement in comparison to a Vitamin C/E supplement and an inert placebo on heart health. There were three treatment groups: Maharishi Amrit Kalash (MAK), vitamin C+E and the placebo group. The primary outcome was smooth muscle responsiveness, blood flow and dilation using the brachial artery reactivity test in a Black population at risk for heart disease.

Detailed description

This was a randomized placebo controlled clinical trial that recruited 143 urban Black men and women at risk for cardiovascular disease (CVD) in the Washington, DC and surrounding areas. Participants were randomly assigned to one of three treatment groups: Maharishi Amrit Kalash (MAK), Vitamin C and E supplement (VitCE) or placebo. The intervention period was 12 months. Study inclusion criteria was the following: Black (self-identified), atherosclerotic coronary heart disease defined by a clinical history of myocardial infarction, coronary revascularization procedure (CABG or coronary angiography with at least one artery showing \>50% stenosis, or \> 2 points on the ATP III risk factor scale, informed consent and permission from patients physician. Exclusion criteria included decompensated heart failure, renal or hepatic insufficiency, or contraindications to nitroglycerin. Participants provided written informed con-sent. Institutional review board approval was obtained. All nutritional supplements (i.e. treatments) used in this study were available in white plastic bottles, sealed and capped. Each Participant received one pair of bottles (one yellow and one green) at each clinic visit every two months. All pills were coated white and were manufactured in tablet form to more easily conceal the participants treatment status. Clinical measures included brachial artery reactivity (BART) testing, carotid intima medial thickness (cIMT) assessment and blood pressure and lipid level monitoring.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Maharishi Amrit Kalash
DIETARY_SUPPLEMENT	vitamin C + E
OTHER	Inert Placebo Capsule	placebo is same shape and color as is the active interventions but is inert

Timeline

• Start date: 2002-10-14
• Primary completion: 2006-07-31
• Completion: 2014-10-27
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States