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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Brachial Artery Reactivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Ayurvedic herbal compound
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.
干预措施: Maharishi Amrit Kalash (Dietary Supplement)
vitamin supplement
Vitamin C and E combination supplement. For this study, it was manufactured with the same shape and color as experimental tablet (MAK)
干预措施: vitamin C + E (Dietary Supplement)
placebo
干预措施: Inert Placebo Capsule (Other)
结局指标
主要结局
Brachial Artery Reactivity
时间窗: 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.
次要结局
- carotid intima medial thickness(0 and 12 months)
- blood pressure(0 and 12 months)
- lipid profile(0 and 12 months)
研究者
Robert Schneider, MD
Director and Professor
Maharishi International University