Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: D&G 1g; Drug: Placebo; Drug: D&G 2g

• Registration Number: NCT01033630
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Last Update Submitted: 2009-12-15
• Study First Posted: 2009-12-16
• Last Update Posted: 2009-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

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Exclusion Criteria

• Known intolerance to D&G due to adverse effect, patients with bleeding, disorders or on long-term anticoagulation.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D&G 1g	D&G 1g	Randomly allocated into three groups, D\&G capsule 1g/day
Placebo	Placebo	Image-matched placebo of active treatment
D&G 2g	D&G 2g	Randomly allocated into three groups, D\&G capsule 2g/day

Primary Outcome Measures

Name	Time	Method
Ultrasound study for measuring carotid intima-media thickening (IMT)	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Hong Kong, Hong Kong

Yan Chai Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong