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Trial History Detail on 2013-09-11

CUHK_CCT00088

2005-11-11

Prospective

PBH01

RGC Competitive Earmarked Research Grant 2005/2006

Department of Community and Family Medicine, the CUHK

Prince of Wales Hospital, Shatin Hospital

Prof. William C.W. WONG

Tel and Tel: 22528772

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

Prof. William C.W. WONG

Tel and Tel: 22528772

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

Effects of isoflavone in patients with watchful waiting benign prostate hyperplasia

Yes

2005-09-20

Conditions of the Urinary Tract and Sexual Organs, and Pregnancy

Drug

Dietary supplement soy isoflavone

1 year

placebo (starch)

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

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

Randomized

Placebo

Double-blind

Parallel

2006-01-01

182

Unknown

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

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

No

2011-04-18

ChiCTR-TRC-05000669

2010-05-04


Yes

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