Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010725
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2001-02-02
Brief Title:
Effects of Herbal Antioxidants on Cardiovascular Disease in Older Blacks
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Effects of Herbal Antioxidants on Cardiovascular Disease in Older Blacks
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 45 conventional vitamin cocktail EC 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
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 45 conventional vitamin cocktail EC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50AT000082-02 | NIH | None | httpsreporternihgovquickSearchP50AT000082-02 |
| P50AT000082-01 | NIH | None | None |