The Effect of North American Ginseng on Blood Pressure in Individuals With Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Mean 24 Hour Ambulatory Blood Pressure
研究概览
简要总结
To determine the effect of North American ginseng on blood pressure in individuals with hypertension.
详细描述
Ginseng lacks proper clinical scrutiny for its effect on blood pressure (BP), in spite of observational evidence linking its intake to hypertension. This should be addressed considering the potential overlap between the prevalence of ginseng use and hypertension.
We undertook a single centre, randomized, controlled, double-blinded, crossover trial to determine the effect of North American ginseng (NAG) on 24-hour BP and renal function. After a 4-week placebo run-in, we randomly assigned participants to NAG or placebo treatment for 12-weeks at a dose of 3g/day. This was followed by an 8-week washout, and a subsequent 12-week period in which the opposite treatment was consumed. At run-in, and at weeks 0 and 12 of each treatment period, participants were fitted with an ambulatory BP monitor to assess 24-hour BP and serum cystatin C was measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 85 years
- •hypertension as defined by the use of antihypertensive drugs or a seated systolic blood pressure greater than or equal to 140 mm Hg or a diastolic BP greater than or equal to 90 mm Hg at each of 3 pre-study visits.
排除标准
- •secondary hypertension
- •liver disease
- •unstable angina
- •ginseng use for two months prior to or during the study
- •any changes in the type or dose of antihypertensive drugs one month prior to or during the study
结局指标
主要结局
Mean 24 Hour Ambulatory Blood Pressure
次要结局
- Mean Daytime Ambulatory Blood Pressure
- Mean Nighttime Ambulatory Blood Pressure
- Cystatin C