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

Completed · Not applicable · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT07206901

Run by

Maharishi International University

People needed

143

Starts

2002-10-14

Expected to finish

2014-10-27

Last updated by the study team

2025-10-03

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ethnicity: African American, self-identified
• Age: 55 years and older
• Medically documented coronary artery disease (CAD/CHD): defined by previous myocardial infarction OR revascularization procedure-coronary artery bypass grafting (CABG), or percutaneous transluminal coronary angioplasty (PCTA), OR coronary angiography with at least one coronary artery with > 50% stenosis.
• In the absence of documented CAD/CHD above, then at least two risk factor points on the Framingham/ATPIII risk factor scoring assessment.
• Signed informed consent
• Permission of Participant's primary physician (if feasible)

You may not qualify if…

• Myocardial infarction, unstable angina, coronary artery by-pass grafting (CABG), percutaneous transluminal coronary angioplasty (PTCA), or stroke within preceding three months.
• Carotid artery endarterectomy.
• Arrhythmia atrial fibrillation, second or third degree AV block.
• Congestive heart failure-Class III or IV or ejection fraction less than 30 percent.
• Clinically significant valvular heart disease.
• Clinically significant hepatic or renal failure.
• Major psychiatric disorders, current alcohol/dependency disorder, or other drug abuse dependency disorder.
• Non-cardiac life threatening illness.
• Participating in a formal stress management program.
• Plans to move out of the study area or travel extensively.
• Unwillingness to accept randomization into any study group.

Where it is running

• College of Integrative Medicine — Fairfield, Iowa, United States

Full record on ClinicalTrials.gov

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