Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen
A Novel Randomized Double-Blind Placebo-Control Clinical Trial in High-Risk Hypertensive Subjects
Atherosclerosis (in particular stroke and heart attack) is the most important health issue in modernized society and high blood pressure is an important predisposing factor. Hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal function are particularly vulnerable to these atherosclerotic complications in spite of standard antihypertensive therapies.
Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac symptoms and atherosclerosis-related disorders.
The objective of this study is to test Danshen and Gegen as an cardiovascular-protective adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.
研究概览
详细说明
Danshen and Gegen (D&G) are two traditional herbal medicines used for cardiac symptoms in ancient Chinese medicinal literature. Recent studies suggest their therapeutic effects in blood pressure and lipid-lowering, anti-oxidation, microcirculation-promoting, foam cells-modulation and have beneficial effects on atherogenic process in coronary patients.
To evaluate the potential of D&G in primary atherosclerosis prevention in high risk hypertension. Patients with high risk hypertension associated with left ventricular hypertrophy, diabetes mellitus and renal insufficiency were randomized to receive D&G herbal capsules (2gm/day), or (1gm/day) or identical placebo capsules in double-blind and parallel fashion for 12 months on top of their anti-hypertensive treatments. Flow-mediated dilation (endothelium-dependent dilation, FMD) and nitroglycerin-induced dilation (endothelium-independent dilation, NTG) of brachial artery, and carotid intima-media thickness (surrogate atherosclerosis marker, IMT) were measured by high resolution B-mode ultrasound.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Hong Kong、香港
- Prince of Wales Hospital
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Hong Kong、香港
- Alice Ho Miu Ling Nethersole Hospital
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Hong Kong、香港
- Yan Chai Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- High-risk hypertension: Asymptomatic hypertensive (pretreatment BP>160/95mmHg) subjects, currently blood pressure under control (BP<140/90mmHg),
- Aged 35-70 years
- With either (i)left ventricular hypertrophy on ECG or echocardiographic criteria, (ii) diabetes mellitus, or (iii) mild renal impairment (plasma creatinine 120-250µmol/l)
Exclusion Criteria:
- Known intolerance to D&G due to adverse effect, patients with bleeding, disorders or on long-term anticoagulation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo
Image-matched placebo of active treatment
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Image-matched placebo, made with starch.
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有源比较器：D&G 1g
Randomly allocated into three groups, D&G capsule 1g/day
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Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge.
Gegen is the dried roots of Pueraria lobata (willd.).
The combination in the ratio of 7:3 of the raw herbs.
Capsule form, Orally taken 1g per Day
其他名称：
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有源比较器：D&G 2g
Randomly allocated into three groups, D&G capsule 2g/day
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Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge.
Gegen is the dried roots of Pueraria lobata (willd.).
The combination in the ratio of 7:3 of the raw herbs.
Capsule form, Orally taken 2g per Day
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Ultrasound study for measuring carotid intima-media thickening (IMT)
大体时间：1 year
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1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Blood tests: lipids, creatinine, glucose, fibrinogen, hs-CRP and haemoglobin A1-C Physical examination: Blood pressure, weight, height, body mass index, hip waist ratio
大体时间：1 year
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1 year
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合作者和调查者
调查人员
- 首席研究员：Thomas YK Chan, Prof.、Department of Medicine & Therapeutics, Prince of Wales Hospital
出版物和有用的链接
一般刊物
- Bots ML, Hoes AW, Koudstaal PJ, Hofman A, Grobbee DE. Common carotid intima-media thickness and risk of stroke and myocardial infarction: the Rotterdam Study. Circulation. 1997 Sep 2;96(5):1432-7. doi: 10.1161/01.cir.96.5.1432.
- O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.
- Woo KS, Chook P, Raitakari OT, McQuillan B, Feng JZ, Celermajer DS. Westernization of Chinese adults and increased subclinical atherosclerosis. Arterioscler Thromb Vasc Biol. 1999 Oct;19(10):2487-93. doi: 10.1161/01.atv.19.10.2487.
- Sieveking DP, Woo KS, Fung KP, Lundman P, Nakhla S, Celermajer DS. Chinese herbs Danshen and Gegen modulate key early atherogenic events in vitro. Int J Cardiol. 2005 Oct 20;105(1):40-5. doi: 10.1016/j.ijcard.2004.10.052.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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