Effect of Ginseol Kg1 on Blood Pressure Lowering in Prehypertensive or Stage I Hypertensive Patients: Multicenter, Randomized, Placebo-controlled, Double-blind Study
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group
研究概览
简要总结
In this study, we investigate the effects of Ginseol Kg1 (Korea red ginseng extract) on blood pressure in prehypertensive or stage I hypertensive patients.
详细描述
This is a multicenter, randomized, placebo-controlled, double-blind study. At the end of an initial 2-week washout period, patients fulfilling the inclusion criteria are assigned to three groups, i.e. control group (placebo), low dose Ginseol Kg1 group (100mg), or high dose Ginseol Kg1 (300mg) group. They will intake the study drug for 8 weeks. 24-h ambulatory BP monitoring (ABPM) and pulse wave velocity are measured at the end of the washout period and after 8 weeks of active treatment. At each visit, seated SBP and DBP, heart rate, use of concomitant medication and spontaneously reported adverse events are recorded. Compliance with medication (determined by counting returned tablets) is evaluated at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adults over 20 years
- •Prehypertension or stage 1 hypertension (systolic blood pressure 120~159mmHg or diastolic blood pressure 80~99mmHg)
- •Subject who has not taken medications to treat hypertension within 15 days prior to first visit
排除标准
- •Subject who has been involved in other clinical trials within 30 days prior to first visit
- •Subject who has following diseases within 2 years prior to screening: angina pectoris, myocardial infarction, heart failure, peripheral vascular disease, chronic liver failure, chronic renal failure, diabetes mellitus, hyperthyroidism, hypothyroidism, malignant tumor, mental disease
- •Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100 mmHg during screening period
- •Subject who has hepatic dysfunction(AST, ALT ≥ 2.5 times higher than normal value)
- •Subject who has renal dysfunction(creatinine ≥ 1.5 times higher than normal value)
- •Subject who is pregnant or breast feeding
- •Alcoholic
- •Subject who has an allergy to the ingredients of study product
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Ginseol Kg1, high dose
干预措施: Ginseol Kg1(high dose) (Drug)
Ginseol Kg1, low dose
干预措施: Ginseol Kg1 (low dose) (Drug)
结局指标
主要结局
The difference of the changes in office diastolic and systolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group
时间窗: baseline and 8 week
次要结局
- The difference of the changes in the mean 24-hour ambulatory systolic and diastolic BP after 8 weeks' treatment between placebo and Ginseol Kg1 group.(baseline and 8 week)
- The difference of the change in the brachial-ankle pulse wave velocity after 8 weeks' treatment between placebo and Ginseol Kg1 group.(baseline and 8 week)
- The difference of the change in the hs-CRP after 8 weeks' treatment between placebo and Ginseol Kg1 group.(baseline and 8 week)
- The difference of the change in the lipid profiles after 8 weeks' treatment between placebo and Ginseol Kg1 group(baseline and 8 week)
- The difference of the changes in office diastolic and systolic BP after 4 weeks' treatment between placebo and Ginseol Kg1 group.(baseline and 4 week)
研究者
Kwang-il Kim
Associate professor
Seoul National University Hospital