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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-14

Study Completion Date

2014-10-27

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized double blind placebo controlled trial with two active groups and a placebo control

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ayurvedic herbal compound

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.

Group Type EXPERIMENTAL

Maharishi Amrit Kalash

Intervention Type DIETARY_SUPPLEMENT

vitamin supplement

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

Group Type ACTIVE_COMPARATOR

vitamin C + E

Intervention Type DIETARY_SUPPLEMENT

placebo

Group Type PLACEBO_COMPARATOR

Inert Placebo Capsule

Intervention Type OTHER

placebo is same shape and color as is the active interventions but is inert

Interventions

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Maharishi Amrit Kalash

Intervention Type DIETARY_SUPPLEMENT

vitamin C + E

Intervention Type DIETARY_SUPPLEMENT

Inert Placebo Capsule

placebo is same shape and color as is the active interventions but is inert

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No