A randomized, placebo controlled double-blind, 12-week treatment trial in men with moderate to severe symptoms of benign prostatic hyperplasia. The trail is about to examine the effect of Brizo® on reduction of BPH related symptoms.
1. Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia. 2. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients) 3. Duration - 12 weeks with 3 visits: 0,6,12 weeks 4. The following procedures are utilized: * Physical exams - visit 1,3. * Drugs/food supplement usage questionnaire - visit 1. * Product supply Control - visit 1,2.3 * Clinical laboratory tests : psa, cbc, bun - visit 1,3. * Uroflowmetry test visit - visit 1,3. * IPSS- International Prostate Symptom Score - questionnaire - visit 1, 3. * IIEF questionnaire - visit 1, 3. 5. dosage: 1 capsule twice daily (morning \& evening) can be taken with or without food
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Rabin Medical Center - Clalit Health Services
Petah Tikva, Israel
RECRUITINGImproved index in the IPSS test
Improvement by 3 points and with a significance of P\< 0.05.
Time frame: 12 weeks
Improve UROFLOWMETRY test
Improve from personal baseline in UROFLOWMETRY test at Week 12 .
Time frame: 12 WEEKS
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