Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Completed
Phase 2

Conditions

Hypertension

Treatments

Drug: D&G 1g
Drug: Placebo
Drug: D&G 2g

Study type

Interventional

Funder types

Other

Identifiers

NCT01033630
CRE2005123T

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Image-matched placebo of active treatment
Treatment:
Drug: Placebo
D&G 1g
Active Comparator group
Description:
Randomly allocated into three groups, D&G capsule 1g/day
Treatment:
Drug: D&G 1g
D&G 2g
Active Comparator group
Description:
Randomly allocated into three groups, D&G capsule 2g/day
Treatment:
Drug: D&G 2g

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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