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Trial History Detail on 2011-02-08

CUHK_CCT00170

2008-11-06

Prospective

ICM/CTS/08/346

Institute of Chinese Medicine

Department of Medicine & Therapeutics, CUHK

Institute of Chinese Medicine, CUHK Department of Chemical Pathology, CUHK Community and Family Medicine, CUHK

Winnie Lo (Research Nurse)

Institute of Chinese Medicine, CUHK

2252 8863

winnielo@cuhk.edu.hk

ICM, CUHK

Prof. Timothy Kwok (PI)

Department of Medicine & Therapeutics, Prince of Wales Hospital, CUHK

2632 3594

tkwok@cuhk.edu.hk

Medicine & Therapeutics, Prince of Wales Hospital, CUHK

A randomized placebo controlled trial of Alternative Herbal Medicine (Danshen/Gegen) in the prevention of atherosclerosis in postmenopausal women with Hypercholesterolemia

A randomized placebo controlled trial of Alternative Herbal Medicine (Danshen/Gegen) in the prevention of atherosclerosis in postmenopausal women with Hypercholesterolemia

Trial of Danshen/Gegen in postmenopausal women with hypercholesterolemia

Hong Kong

Yes

2008-10-21

Postmenopausal women with Hypercholesterolemia at risk of Atherosclerosis

Drug

Danshen/Gegen (Herbal Medicine)

52weeks

Placebo; 52 weeks

Inclusion Criteria: Women aged 45-65 years who had not had menstruation for more than 12 months and with fasting serum LDL ≥ 3.5mmol/L and < 4.9mmol/L. Subjects with serum LDL >4.9 mmol/L will be advised to take statin as recommended by the US guideline, but will be allowed to participate in this trial if they so wish.

Exclusion Criteria: history of diabetes mellitus, hypertension, ischaemic heart disease, cerebrovascular disease, renal impairment, significant drug hypersensitivity, current smoking, hormonal replacement, lipid lowering drugs, blood pressure >140/90 mmHg on two separate occasions, fasting glucose > 7.0 mmol/L, creatinine >100µmol/L, triglyceride > 11.3 mmol/L, significant ischaemic ECG changes or angina symptom.

45

65

Female

Interventional

Randomized

Placebo

Double-blind

Parallel

2008-11-11

160

Recruiting

Carotid Intima-media thickness at 12 month

Serum LDL at 12 Month Serum triglyceride at 12 Month

No

2011-03-04

ChiCTR-TRC-09000727

2010-05-04


Yes

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