BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS) Clinical Trial
Official title:
A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
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 ;