Status:
COMPLETED
Evaluation of an Ayurvedic Herbal Compound Compared to Vitamins C+E and Placebo on Vascular Function in High-Risk Subjects
Lead Sponsor:
Maharishi International University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Howard University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
55-90 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2014
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT07206901
Start Date
October 14 2002
End Date
October 27 2014
Last Update
October 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
College of Integrative Medicine
Fairfield, Iowa, United States, 52556