Coronary Artery DiseaseNCT07206901
Evaluation of an Ayurvedic Herbal Compound Compared to Vitamins C+E and Placebo on Vascular Function in High-Risk Subjects
A study testing Maharishi Amrit Kalash and vitamin C + E in people with Coronary Artery Disease, run by Maharishi International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Maharishi Amrit Kalash and vitamin C + E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2002to 27 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
College of Integrative Medicine
Fairfield, Iowa, 52556
About this study
Official title: Evaluation of an Ayurvedic Herbal Compound (Maharishi Amrit Kalash) Compared to Vitamins C+E and Placebo on Vascular Function in High CVD Risk Subjects: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Maharishi Amrit Kalash, vitamin C + E, Inert Placebo Capsule
- Keywords
- brachial artery reactivity (BART), Maharishi Amrit Kalash (MAK), herbal preparation, Ayurvedic herbal preparation, vascular function
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Dietary Supplement: vitamin C + E |
| placebo | Placebo comparator | Not described Receives: Other: Inert Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 months and 12 months
Secondary outcomes (3)
carotid intima medial thickness
B mode doppler ultrasound measurement of the carotid artery
Measured: 0 and 12 months
blood pressure
clinical assessment of systolic and diastolic blood pressure
Measured: 0 and 12 months
lipid profile
laboratory assessment of blood levels of cholesterol, LDL, HDL and triglycerides
Measured: 0 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start14 Oct 2002
- Primary completion31 Jul 2006
- Study completion27 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blind placebo controlled trial with two active groups and a placebo control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Howard University
- Responsible party
- Principal investigator, Robert Schneider, MD, Maharishi International University
- Investigators
- Robert H Schneider, MD, Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206901
- Sponsor's protocol ID
- HH2100mdjs
- Other IDs
- P50AT000082
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: raw data can be shared along with Participant ID codes but not full names, initials or contact information about the study participants
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Ayurvedic Herbal Compound (Maharishi Amrit Kalash) Compared to Vitamins C+E and Placebo on Vascular Function in High CVD Risk Subjects: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07206901
- Acronym / sponsor ID
- HH2100mdjs
- Conditions
- Coronary Artery Disease
- Keywords
- brachial artery reactivity (BART), Maharishi Amrit Kalash (MAK), herbal preparation, Ayurvedic herbal preparation, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Howard University
- Study start
- 14 Oct 2002 (actual)
- Primary completion
- 31 Jul 2006 (actual)
- Study completion
- 27 Oct 2014 (actual)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized double blind placebo controlled trial with two active groups and a placebo control
| Arm | Type | Receives |
|---|---|---|
| Ayurvedic herbal compound | Experimental | Dietary Supplement: Maharishi Amrit KalashMaharishi 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. |
| vitamin supplement | Active comparator | Dietary Supplement: vitamin C + EVitamin C and E combination supplement. For this study, it was manufactured with the same shape and color as experimental tablet (MAK) |
| placebo | Placebo comparator | Other: Inert Placebo Capsule |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maharishi Amrit Kalash | Dietary supplement | Ayurvedic herbal compound |
| vitamin C + E | Dietary supplement | vitamin supplement |
| Inert Placebo Capsuleplacebo is same shape and color as is the active interventions but is inert | Other | placebo |
Primary outcome
Brachial Artery Reactivity
Time frame: 0 months and 12 months
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.
3 secondary outcomes
carotid intima medial thickness
Time frame: 0 and 12 months
blood pressure
Time frame: 0 and 12 months
lipid profile
Time frame: 0 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. raw data can be shared along with Participant ID codes but not full names, initials or contact information about the study participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Schneider, MD principal investigator
Maharishi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maharishi Amrit Kalash and vitamin C + E in people with Coronary Artery Disease, run by Maharishi International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Reactivity (time frame: 0 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.