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

NCT07206901 | Completed DMC

• 2 other identifiers: HH2100mdjsP50AT000082
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

brachial artery reactivity (BART); Maharishi Amrit Kalash (MAK); herbal preparation; Ayurvedic herbal preparation; vascular function

Outcome Measures

Primary Outcomes (1)

• 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.

  0 months and 12 months

Secondary Outcomes (3)

• carotid intima medial thickness

  0 and 12 months

• blood pressure

  0 and 12 months

• lipid profile

  0 and 12 months

Study Arms (3)

Ayurvedic herbal compound

EXPERIMENTAL

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.

Dietary Supplement: Maharishi Amrit Kalash

vitamin supplement

ACTIVE COMPARATOR

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

Dietary Supplement: vitamin C + E

placebo

PLACEBO COMPARATOR

Other: Inert Placebo Capsule

Interventions

Maharishi Amrit Kalash DIETARY_SUPPLEMENT

Ayurvedic herbal compound

vitamin C + E DIETARY_SUPPLEMENT

vitamin supplement

Inert Placebo Capsule OTHER

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

placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Maharishi International University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Howard University: collaborator

Study Sites (1)

College of Integrative Medicine

Fairfield, Iowa, 52556, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Maharishi Amrit Kalash; Ascorbic Acid

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Robert H Schneider, MD

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor

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

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: October 3, 2025
• Study Start: October 14, 2002
• Primary Completion: July 31, 2006
• Study Completion: October 27, 2014
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)