Clinical trial NCT01033630: Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen
Official title: A Novel Randomized Double-Blind Placebo-Control Clinical Trial in High-Risk Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasound study for measuring carotid intima-media thickening (IMT)
timeFrame: 1 year
Secondary outcomes:
measure: Blood tests: lipids, creatinine, glucose, fibrinogen, hs-CRP and haemoglobin A1-C Physical examination: Blood pressure, weight, height, body mass index, hip waist ratio
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Yan Chai Hospital
Study officials:
affiliation: Department of Medicine & Therapeutics, Prince of Wales hospital
name: Thomas YK Chan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bots ML, Hoes AW, Koudstaal PJ, Hofman A, Grobbee DE. Common carotid intima-media thickness and risk of stroke and myocardial infarction: the Rotterdam Study. Circulation. 1997 Sep 2;96(5):1432-7. doi: 10.1161/01.cir.96.5.1432.
citation: O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.
citation: Woo KS, Chook P, Raitakari OT, McQuillan B, Feng JZ, Celermajer DS. Westernization of Chinese adults and increased subclinical atherosclerosis. Arterioscler Thromb Vasc Biol. 1999 Oct;19(10):2487-93. doi: 10.1161/01.atv.19.10.2487.
citation: Sieveking DP, Woo KS, Fung KP, Lundman P, Nakhla S, Celermajer DS. Chinese herbs Danshen and Gegen modulate key early atherogenic events in vitro. Int J Cardiol. 2005 Oct 20;105(1):40-5. doi: 10.1016/j.ijcard.2004.10.052.