Evaluation and Standardization of Ginseng and it's Components for Blood Pressure Regulation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Flow-mediated dilation of the brachial artery
研究概览
简要总结
Ginseng has been used for many years in a wide array of anecdotal medicinal properties. Animal and limited clinical research points to the vascular effects of Korean Red Ginseng (KRG). The present project aims to assess the efficacy of KRG and contribution of its factionated components on various indices of vascular function in healthy individuals. Our primary objective is to compare the acute effects of KRG and placebo on endothelial function. Moreover, our secondary objective is to evaluate the effect of isolated KRG factions on arterial stiffness, blood pressure and vasoactive markers. We hypothesize that (1) consumption of KRG will cause an improvement in endothelial function in healthy individuals, as compared to placebo; (2) consumption of KRG will cause an improvement in arterial stiffness and blood pressure in healthy individuals, as compared to placebo; (3) the ginsenoside faction of KRG is primarily responsible for the anticipated vascular effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: between 18 and 70 years of age
- •Healthy individuals (absence of major illnesses)
排除标准
- •Primary hypertension (defined by the use of antihypertensive agents or a seated systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than 90mmHg)
- •Secondary hypertension (defined as SBP greater than 180mmHg and DBP greater than 110mmHg)
- •Grade 3 hypertension (defined as SBP greater than 180mmHg and DBP greater than 110mmHg)
- •Chronic kidney disease
- •Liver disease
- •Estrogen-sensitive cancer
- •Heavy alcohol use
- •Bleeding disorders
- •Planned surgery
- •Coronary revascularization
- •Peripheral vascular disease
- •Coronary/cerebrovascular event in the last 6 months
- •Prescriptions of MAO inhibitors, SSRIs, diuretics, sympathomimetics, herbal therapies, medication affecting nitric oxide synthesis, and/or anticoagulent medications within the last 6 months
- •Sensitivity to any of the ingredients in the treatments or placebo
- •Chronic use of or frequent prescriptions for NSAIDs
- •Women of childbearing potential must not be pregnant or breast-feeding
结局指标
主要结局
Flow-mediated dilation of the brachial artery
时间窗: Start and finish of each treatment arm
次要结局
- Nitric Oxide and Cyclic GMP(Beginning of and 3 hours into clinical visit)
- Augmentation Index(Start and finish of each treatment arm)