Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00170

2 Trial Registration Date

2008-11-06

i Registration Status

Prospective

3 Secondary IDs

ICM/CTS/08/346

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

Department of Medicine & Therapeutics, CUHK

6 Secondary Sponsor

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

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Winnie Lo (Research Nurse)

ii Address

iii Phone

Institute of Chinese Medicine, CUHK

iv Email

Tel: 2252 8863

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Timothy Kwok (PI)

ii Address

iii Phone

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

iv Email

Email: tkwok@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Trial of Danshen/Gegen in postmenopausal women with hypercholesterolemia

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-10-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Postmenopausal women with Hypercholesterolemia at risk of Atherosclerosis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Danshen/Gegen (Herbal Medicine)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

52weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo; 52 weeks

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion Criteria: Women aged 45-65 years who had not had menstruation for more than 12 months and with fasting serum LDL ≥ 4.1mmol/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.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-11-11

21 Target Sample Size

160

22 Recruitment Status

Recruiting

23 Primary Outcome

Carotid Intima-media thickness at 12 month

24 Secondary Outcome

Serum LDL at 12 Month Serum triglyceride at 12 Month

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-03-04

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2008-11-18