Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00062

2 Trial Registration Date

2005-09-12

i Registration Status

Retrospective

3 Secondary IDs

N/A

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Benny Fok

ii Address

Department of Medicine and Therapeutics

iii Phone

26323377

iv Email

bfok@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

i Name

Brian Tomlinson

ii Address

Department of Medicine and Therapeutics

iii Phone

26323139

iv Email

btomlinson@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

Study of the effects of Lingzhi therapy on cardiovascular, metabolic, antioxidant and inflammation parameters

10 Public Title

Study of the effects of Lingzhi therapy on cardiovascular, metabolic, antioxidant and inflammation parameters

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

n/a

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2001-09-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Heart and Blood Vessel Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Lingzhi capsule

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

32 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

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

Patients with mild hypertension

ii Exclusion Criteria

Patients with recent ischemic events

iii Age Minimum

18

iv Age Maximum

no limit

v Gender

Both Male and Female

18 Study Type

Interventional

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

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2001-11-01

21 Target Sample Size

25

22 Recruitment Status

Complete

23 Primary Outcome

Changes in blood pressure and plasma lipid

24 Secondary Outcome

Changes in plasma antioxidant status, markers of inflammation and endothelial function.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-26

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000654

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2011-02-08