Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Novel Randomized Double-Blind Placebo-Control Clinical Trial in High-Risk Hypertensive Subjects

Conditions
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Hypertension

Intervention / Treatment
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* Drug: D&G 2g
* Drug: D&G 1g
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Image-matched placebo of active treatment | Drug: Placebo<br>* Image-matched placebo, made with starch.<br>|
| Active Comparator: D&G 1g<br>Randomly allocated into three groups, D&G capsule 1g/day | Drug: D&G 1g<br>* 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<br>* Other names: Danshen Gegen;|
| Active Comparator: D&G 2g<br>Randomly allocated into three groups, D&G capsule 2g/day | Drug: D&G 2g<br>* 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<br>* Other names: Danshen Gegen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound study for measuring carotid intima-media thickening (IMT) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood tests: lipids, creatinine, glucose, fibrinogen, hs-CRP and haemoglobin A1-C Physical examination: Blood pressure, weight, height, body mass index, hip waist ratio |  | 1 year |