Hypertension Clinical Trial
Official title:
A Novel Randomized Double-Blind Placebo-Control Clinical Trial in High-Risk Hypertensive Subjects
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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