NCT02663479已完成1 期
Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic hypertension: Blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm Hg but less than 180 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg but less than 105 mm Hg
- •Subjects are not taking any prescription anti-hypertensive drugs.
- •Subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study.
排除标准
- •Myocardial infarction, PTCA , stent, CABG within 5 years, known clinical CHD or clinical angina.
- •History of cerebrovascular accident (CVA).
- •Creatinine over 2.5 mg/dL.
- •Known allergy or sensitivity to any components of the study blood pressure supplement.
- •Chronic liver disease with AST, ALT, alkaline phosphatase over 1.5 x normal lab values.
- •Known cancer within 2 years.
- •Clinical congestive heart failure ( systolic or diastolic CHF)
- •Pregnant and nursing women and women.
- •Women of child bearing age not on approved contraception control.
- •Type 1 and Type 2 diabetes mellitus on medications.
- •If the study subjects develop BP over 180 mm Hg systolic or 110 mm Hg diastolic during the study, they will be discontinued from the study and the investigator will immediately start rescue drug therapy for BP control.
研究组 & 干预措施
Cardiopressin
Experimental
A 5 capsule proprietary blend of herbal extracts and nutrients
干预措施: Cardiopressin (Dietary Supplement)
Placebo
Placebo Comparator
A 5 capsule placebo matched in color and size to the Experimental supplement
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Blood Pressure
时间窗: 4 months
Reduction in systolic and diastolic blood pressure as measured by office readings and 24 hour ABM ( ambulatory blood pressure monitor)
次要结局
- Endothelial Function(4 months)
- Small arterial compliance(4 months)
- Large arterial compliance(4 months)
- Central arterial blood pressure(4 months)
研究者
研究点 (1)
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