Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00158

2 Trial Registration Date

2008-03-06

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

No

5 Primary Sponsor

No

6 Secondary Sponsor

No

Function

Please specify

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

i Name

Chi-Fai NG

ii Address

iii Phone

852-26322625; ngcf@surgery.cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

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

i Name

Chi-Fai NG

ii Address

iii Phone

852-26322625; ngcf@surgery.cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Prospective trial of a herbal formula BYSH and saw palmetto in patients with hormonal refractory prostate cancer

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Traditional chinese medicine in hormonal refractory prostate cancer

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-08-23

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Prostate Cancer

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Traditional Chinese Medicine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

up to 1 year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

No

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

Histological Proven prostate cancer with clinically hormonal refractory and not suitable or not agreeable for chemotherapy

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

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-03-13

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Time to PSA progression

24 Secondary Outcome

Quality of life

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

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

None

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Trial History Detail on 2008-03-06