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

N/ACompletedNCT07206901

Maharishi International University143 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Coronary Artery Disease

Interventions

Maharishi Amrit KalashDIETARY_SUPPLEMENT

vitamin C + EDIETARY_SUPPLEMENT

Inert Placebo CapsuleOTHER

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

College of Integrative Medicine

Fairfield, Iowa, United States

Outcomes

Primary Outcomes

Brachial Artery Reactivity

This is a clinical test or protocol that measures the reactivity of the brachial artery and its ability to vasodilate in response to increased blood flow, typically assessed using ultrasound imaging. It is administered with a hyperemia phase (occlusion of the right arm with a cuff) followed by release and/or a sublingual nitroglycerin phase in which a small dose of nitroglycerin is placed under the tongue of the patient in a supine position. In each case, the flow mediated dilation (FMD) of the brachial artery is measured as a marker of vascular health.

Time frame: 0 months and 12 months

Secondary Outcomes

carotid intima medial thickness

B mode doppler ultrasound measurement of the carotid artery

Time frame: 0 and 12 months

blood pressure

clinical assessment of systolic and diastolic blood pressure

Time frame: 0 and 12 months

lipid profile

laboratory assessment of blood levels of cholesterol, LDL, HDL and triglycerides

Time frame: 0 and 12 months

Data from ClinicalTrials.gov

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