Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- central blood pressure change after treatment of Korea Red Ginseng
研究概览
简要总结
The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease central blood pressure in subjects with hypertension.
详细描述
Participants with hypertension who were treated with antihypertensive agents were randomly assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over manner.
Participants were not allowed to change their antihypertensive medications except safety issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at baseline,at 2 and 4 months.
Efficacy and safety data will be monitored by Daegu Catholic University Medical Center Institutional Review Board and reported to the Korean Ginseng Society.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Essential hypertension
- •diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less
排除标准
- •Secondary hypertension
- •Serum creatinin above 1.5 mg/dL
- •aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper normal limits
- •Uncontrolled diabetes (Hb A1c < 9%)
- •Acute myocardial infarction or coronary artery disease intervention within six months
- •Moderate to severe congestive heart failure
- •HIV positive
- •Immunocompromized host
- •Allergy to Korean red ginseng
- •Pregnancy or plan to pregnancy
- •Alcohol or drug abuse
- •Attend to other clinical trial within 12 weeks
研究组 & 干预措施
Active(Korean Red Ginseng) first group:
Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
干预措施: Korean Red Ginseng Capsules (Drug)
Placebo capsules
placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week
干预措施: Placebo (Drug)
结局指标
主要结局
central blood pressure change after treatment of Korea Red Ginseng
时间窗: baseline, 8 weeks and 16 weeks after treatment
次要结局
- CRP(C-reactive protein)(baseline, 8 week, 16 week.)
- ESR(erythrocyte sedmentation rate)(baseline, 8 week, 16 week.)
- Augumentation index(baseline, 8 week, 16 week.)
- brachial systolic and diastolic blood pressure(baseline, 8 week, 16 week.)
研究者
Jin Bae Lee
Associate professor
Daegu Catholic University Medical Center