Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia

NCT ID: NCT00861588

Last Updated: 2009-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-09-30

Brief Summary

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.

Conditions

Benign Prostate Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

isoflavones

Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive isoflavones

Group Type: EXPERIMENTAL

isoflavones (Soylife 25)

Intervention Type: DRUG

40mg of soy isoflavones capsule (once daily)

starch

Subjects who met the inclusion and exclusion criteria would be randomly assigned (concealment of allocation) to receive placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

starch placebo

Interventions

isoflavones (Soylife 25)

40mg of soy isoflavones capsule (once daily)

Intervention Type: DRUG

placebo

starch placebo

Intervention Type: DRUG

Other Intervention Names

Soylife 25

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

School of Pharmacy, CUHK

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

The Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 22268969 (View on PubMed)

Other Identifiers

CUHK4453/05M

Identifier Type: -

Identifier Source: org_study_id