Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

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