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

Maharishi International University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: Maharishi Amrit Kalash; Dietary Supplement: vitamin C + E; Other: Inert Placebo Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07206901

P50AT000082 (U.S. NIH Grant/Contract)

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 3 patient groups, including a placebo group

Ayurvedic herbal compound

Experimental group

Description:

Maharishi Amrit Kalash (MAK) is an Ayurvedic herbal compound classified as a Rasayana. MAK is a commercially available product that can be purchased and consumed in paste or tablet form. For this double blind study, MAK was administered in tablet form.

Treatment:

Dietary Supplement: Maharishi Amrit Kalash

vitamin supplement

Active Comparator group

Description:

Vitamin C and E combination supplement. For this study, it was manufactured with the same shape and color as experimental tablet (MAK)

Treatment:

Dietary Supplement: vitamin C + E

placebo

Placebo Comparator group

Treatment:

Other: Inert Placebo Capsule