Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00088

2 Trial Registration Date

2005-11-11

i Registration Status

Prospective

3 Secondary IDs

PBH01

4 Source(s) of Funding

RGC Competitive Earmarked Research Grant 2005/2006

5 Primary Sponsor

Department of Community and Family Medicine, the CUHK

6 Secondary Sponsor

Prince of Wales Hospital, Shatin Hospital

Function

Please specify

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

i Name

Prof. William C.W. WONG

ii Address

iii Phone

Tel and Tel: 22528772

iv Email

E-mail E-mail: cwwong@cuhk.edu.hk

v Affiliation

vi Country

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

i Name

Prof. William C.W. WONG

ii Address

iii Phone

Tel and Tel: 22528772

iv Email

E-mail E-mail: cwwong@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Effects of isoflavone in patients with watchful waiting benign prostate hyperplasia

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-09-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Conditions of the Urinary Tract and Sexual Organs, and Pregnancy

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Dietary supplement soy isoflavone

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

placebo (starch)

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: 1. Chinese ethnicity 2. Age 45-85 y 3. Diagnosed to have watchful waiting BPH (Qmax< 15 ml/sec and post-voided volume > 150 mL and IPSS score <= 19) 4. Not on any concurrent alternative medications for BPH 5. Mentally capable to give informed written consent and willing to comply with study requirements

ii Exclusion Criteria

Exclusion: 1. Prefers to have conventional medical or surgical treatment for BPH 2. Concurrent treatment for unstable chronic diseases including unstable angina, less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year) 3. Known to have prostate cancer (PSA > 4 or Biopsy is +ve) or kidney and/or liver failure

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

2006-01-01

21 Target Sample Size

182

22 Recruitment Status

Recruiting

23 Primary Outcome

improvement in the uroflowmetry with a change of Qmax > 2 mL/sec after 12 months treatment when compared to placebo

24 Secondary Outcome

improvement in symptoms and quality of life measured in the scores of IPSS and SF-12

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-18

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000669

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2011-02-08