Effects of Herbal Antioxidants on Cardiovascular Disease in Older Blacks

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010725
First received: February 2, 2001
Last updated: January 11, 2010
Last verified: January 2010

February 2, 2001
January 11, 2010
September 1999
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Complete list of historical versions of study NCT00010725 on ClinicalTrials.gov Archive Site
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Effects of Herbal Antioxidants on Cardiovascular Disease in Older Blacks
Effects of Herbal Antioxidants on Cardiovascular Disease in Older Blacks

The purpose of this study is to compare an herbal supplement, nonfood-derived vitamins, and placebo for the care of cardiovascular disease in high risk older African Americans.

Older African Americans suffer from disproportionately high rates of cardiovascular disease (CVD) morbidity and mortality. In response to the health disparity between older African Americans and whites, national mandates have called for new research on innovative approaches to CVD prevention in this high risk population. Oxidative stress has recently been implicated in the pathogenesis of atherosclerotic CVD. Available evidence from epidemiological studies, clinical trials, and laboratory mechanistic studies indicate that antioxidant interventions may be useful in the prevention and treatment of atherosclerotic CVD in high risk older populations. Furthermore, it has been hypothesized that dietary or food sources of antioxidant nutrients may be more clinically effective than conventional nonfood-derived vitamin supplementation. Surveys indicate relatively high rates of complementary and alternative medicine (CAM) use, including herbal medicines, in older African Americans. Yet, with the exception of the previous clinical trials of the present Center team, there have been few controlled studies on CAM therapies in older African Americans and no previous controlled studies on efficacy and mechanisms of herbal antioxidants for the prevention of CVD in this high risk population. Preliminary studies have found that a CAM herbal preparation (MAK) derived from traditional Vedic medicine demonstrates potent antioxidant and anti-atherogenic effects in laboratory and pilot human studies. This study will evaluate the effects of this traditional CAM herbal preparation in older African Americans.

This will be a controlled clinical trial at field site, Howard University Medical Center in Washington, DC, involving 138 older African American men and women (55 years of age and older) with documented atherosclerotic CVD who will be randomized to supplementation with either the traditional CAM herbal preparation (MAK 4+5), conventional vitamin cocktail (E+C) or placebo for 12 months. Clinical and mechanistic outcomes include carotid artery atherosclerosis (IMT), endothelial dysfunction (brachial artery reactivity), oxidized LDL, traditional CVD risk factors (BP, lipids, diet, exercise, smoking, weight) and quality of life. Participants will continue usual care. The results of this clinical study will provide much needed understanding of the basic and clinical effects of a traditional herbal antioxidant preparation on pathophysiological mechanisms of atherosclerotic CVD in this high risk group. This will facilitate translation of research findings on CAM into clinical practice for prevention of disease in this underserved and understudied population of high risk older African Americans.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Cardiovascular Diseases
  • Drug: MAK
  • Drug: Vitamin Supplements
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
August 2004
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Inclusion Criteria:

  • African American (self-identified)
  • Atherosclerotic coronary heart disease (CHD)defined by documented clinical history of myocardial infarction, coronary revascularization procedure (CABG, PTCA), or coronary angiography demonstrating at least one coronary artery with >50% stenosis
  • High risk for CVD, defined as >=2 on Framingham/ATP III risk factor scale
  • Informed consent
  • Written permission of participant's referring physician
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010725
P50 AT000082-01P3, P50AT000082-01, P50AT000082-02
Yes
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Robert H. Schneider Center for Health and Aging Studies
National Center for Complementary and Alternative Medicine (NCCAM)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP