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NCT Number: NCT01033630

Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alice Ho Miu Ling Nethersole Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D&G 2g

Drug

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

Other names: Danshen Gegen

D&G 1g

Drug

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

Other names: Danshen Gegen

Placebo

Drug

Image-matched placebo, made with starch.

Primary outcomes

  1. Ultrasound study for measuring carotid intima-media thickening (IMT)

    Time frame: 1 year

Secondary outcomes

  1. Blood tests: lipids, creatinine, glucose, fibrinogen, hs-CRP and haemoglobin A1-C Physical examination: Blood pressure, weight, height, body mass index, hip waist ratio

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 16, 2009
Registry last updated
Dec 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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