Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00059

2 Trial Registration Date

2005-09-09

i Registration Status

Retrospective

3 Secondary IDs

N/A

4 Source(s) of Funding

RGC Grant

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

The Chinese University of Hong Kong

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

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Evaluation of two traditional Chinese medicine formulations for the treatment of the metabolic syndrome regarding cardiovascular function and insulin sensitivity

10 Public Title

Evaluation of two traditional Chinese medicine formulations for the treatment of the metabolic syndrome regarding cardiovascular function and insulin sensitivity

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?

1999-09-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Gland and Hormone Related Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Three Essence Capsule

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 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 type 2 diabetes

ii Exclusion Criteria

uncontrolled condition requiring treatment modification

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

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2001-07-01

21 Target Sample Size

40

22 Recruitment Status

Complete

23 Primary Outcome

Changes in fasting and 2hr plasma glucose when challenged by a oral glucose tolerance test

24 Secondary Outcome

Cardiovascular function measured by impedance and psychomotor function

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000651

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