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Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

This study has been completed.
Sponsor:
Collaborator:
School of Pharmacy, CUHK
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00861588
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 12, 2009
March 12, 2009
February 2006
September 2007   (final data collection date for primary outcome measure)
  • The primary safety endpoint is tolerability i.e. discontinuation due to an adverse event. The primary efficacy outcome will be an improvement in the urine flow rate by at least 2ml/sec after 12 months treatment when compared to placebo. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in the International Prostate Symptom Score (IPSS) and Sf-36 respectively. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
The secondary efficacy outcome measure will include an improvement in symptoms and quality of life measured in IPSS and Sf-36 respectively. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia
Not Provided

Benign prostatic hyperplasia (BPH) is a common problem among aging Caucasian men that produces significant morbidity and hea1th care costs. It is likely that BPH is just as common among Chinese men. Debate exists as to whether currently available surgical and pharmacological options for BPH are appropriate for men in the watchful-waiting stage of this condition. Evidence suggests that the consumption of soy isoflavones is related to lower rates of BPH among Asian men. The advantages of soy isoflavones over conventional therapies may include better patient compliance, improved safety and lower cost. Despite the fact that soy isoflavones are safe and contain a health-conferring ingredient with a defined mechanism of action, no randomised control trial has been performed using isoflavones to treat BPH. Therefore, a randomised control trial is proposed to test the tolerability and effectiveness of soy isoflavones (Soylife) verses placebo in 182 men with defined watchful waiting BPH over a period of 12 months. In this trial, patients who fulfill the inclusion criteria, will either be given 40mg of soy isoflavones capsule (once daily) or a placebo capsule. They will be reviewed every three months with maximal urine flow rate, international prostate symptoms score and quality of life measured. Baseline tests include RFT, LFT, FBC, MSU, PSA and testosterone and to be repeated at 6th month and 12th month. The investigators hypothesize that this intervention will reduce lower urinary tract symptoms and slow the progression of the disease.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Benign Prostate Hyperplasia
  • Drug: isoflavones (Soylife 25)
    40mg of soy isoflavones capsule (once daily)
    Other Name: Soylife 25
  • Drug: placebo
    starch placebo
  • Experimental: isoflavones
    Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive isoflavones
    Intervention: Drug: isoflavones (Soylife 25)
  • Placebo Comparator: starch
    Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive placebo
    Intervention: Drug: placebo
Wong WC, Wong EL, Li H, You JH, Ho S, Woo J, Hui E. Isoflavones in treating watchful waiting benign prostate hyperplasia: a double-blinded, randomized controlled trial. J Altern Complement Med. 2012 Jan;18(1):54-60. doi: 10.1089/acm.2010.0077.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chinese ethnicity
  • Age between 45-85 years
  • Diagnosed to have watchful waiting BPH (Qmax< 15 ml/sec together with a voided volume of more than 150 mls)
  • Not on any concurrent alternative medications for BPH
  • Mentally capable to give informed written consent and willing to comply with study requirements

Exclusion Criteria:

  • Prefers to have conventional medical or surgical treatment for BPH
  • Concurrent treatment for unstable chronic diseases including unstable angina, poorly controlled DM (HbA1c >7.5), less than 3 months post-MI or frequent exacerbation of COPD (more than 3x in the last year)
  • Known to have prostate cancer or kidney and/or liver failure
  • Urinary symptoms due to known causes other than BPH including neurogenic bladder, urinary tract infection, bladder cancer, bladder stone, urethral stricture
  • Previous history of prostatic surgery
  • Illiterate or having difficulty in filling in a patient diary
Male
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00861588
CUHK4453/05M
No
William CW wong, The Chinese University of Hong Kong
Chinese University of Hong Kong
School of Pharmacy, CUHK
Not Provided
Chinese University of Hong Kong
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP