Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00324

2 Trial Registration Date

2012-06-15

i Registration Status

Prospective

3 Secondary IDs

ICM/CTS/12/350

4 Source(s) of Funding

Institute of Chinese Medicine, CUHK

5 Primary Sponsor

Department of Sports Science and Physical Education, CUHK

6 Secondary Sponsor

Institute of Chinese Medicine, CUHK

Function

Please specify

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

i Name

Mr. Bob Sun Feng Hua

ii Address

Kwok Sports Building, Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin.

iii Phone

3943 6085

iv Email

fhsun@cuhk.edu.hk

v Affiliation

Department of Sports Science and Physical Education, CUHK

vi Country

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

i Name

Prof. Leung Ping Chung

ii Address

5/F, Institute of Chinese medicine, School of Public Health Building, Prince of Wales Hospital, Shatin, N.T.

iii Phone

2252 8863

iv Email

pingcleung@cuhk.edu.hk

v Affiliation

Institute of Chinese Medicine, CUHK

vi Country

9 Official Scientific Title of the Study

Effect of an innovative herbal supplementation on oxidative stress and muscle micro-damage after exercise in healthy males: a double-blinded crossover-designed experimental study

10 Public Title

Effect of an innovative herbal supplementation on oxidative stress and muscle micro-damage after exercise in healthy males: a double-blinded crossover-designed experimental study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Herbal Supplement for oxidative stress

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?

2012-05-28

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Oxidative stress and muscle micro-damage after exercise in healthy males

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Herbal supplement (3 compounds formula sachet: verbascoside, collagen powder, and creatine monohydrate)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

14 Days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Collagen powder; 14 Days
Creatine monohydrate; 14 Days

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

●Young healthy male
●Moderate levels of physical activity in International Physical Activity Questionnaire

ii Exclusion Criteria

●History of gastrointestinal disorders or take any medication or supplement during the past 4 weeks prior to the study.

iii Age Minimum

18

iv Age Maximum

40

v Gender

Male

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2012-06-18

21 Target Sample Size

12

22 Recruitment Status

Recruiting

23 Primary Outcome

Total Anti-oxidant Capacity included blood glucose, lactate, serum insulin, cortisol, isoprostanes levels and CK levels

24 Secondary Outcome

Muscle Soreness Scale

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-04-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TTRCC-12002359

28 Date of Registration in Primary Registry

2012-07-22

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-12-07