BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)
Conditions
Brief summary
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.
Detailed description
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
Interventions
DIETARY_SUPPLEMENTBRIZO
A capsule containing 400 mg. SC012 (unique soy extract)
OTHERplacebo
Comprecel microcrystalline cellulose
Sponsors
Clalit Health Services
Se-cure Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
* Study arm- min. 80 patients * Placebo arm- min. 40 patients
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Males in good general health at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia
Exclusion criteria
* Inability to complete the questionnaire. * Patients with or suspected of having prostate cancer. * Patients who have undergone a surgical procedure in the past year and / or who have taken medications or supplements in the past six months to treat BPH. * Patients treated with drugs for kidney / urinary tract problems. * Allergy to soy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved index in the IPSS test | 12 weeks | Improvement by 3 points and with a significance of P\< 0.05. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improve UROFLOWMETRY test | 12 WEEKS | Improve from personal baseline in UROFLOWMETRY test at Week 12 . |
Countries
Israel
Contacts
Primary ContactOhad Shoshani, MD
Backup ContactAdi Raz
Outcome results
None listed