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Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen

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ClinicalTrials.gov Identifier: NCT01033630
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : December 16, 2009
Sponsor:
Information provided by:
Chinese University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: D&G 2g Drug: D&G 1g Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Randomized Double-Blind Placebo-Control Clinical Trial in High-Risk Hypertensive Subjects
Study Start Date : January 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Image-matched placebo of active treatment
 Drug: Placebo
Image-matched placebo, made with starch.
Active Comparator: D&G 1g
Randomly allocated into three groups, D&G capsule 1g/day
 Drug: D&G 1g
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 Name: Danshen Gegen
Active Comparator: D&G 2g
Randomly allocated into three groups, D&G capsule 2g/day
 Drug: D&G 2g
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 Name: Danshen Gegen


Outcome Measures
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Primary Outcome Measures :
  1. Ultrasound study for measuring carotid intima-media thickening (IMT) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033630


Locations
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Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Yan Chai Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Thomas YK Chan, Prof. Department of Medicine & Therapeutics, Prince of Wales hospital
More Information
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Publications:

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Responsible Party: Prof. Thomas Yan Keung Chan, Department of Medicine and Therapeutics, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01033630    
Other Study ID Numbers: CRE2005123T
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: December 16, 2009
Last Verified: January 2006
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases