The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)

Study Overview
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Brief Summary
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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
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Males in good general health 50 years of age and older, with symptoms of moderate to severe benign prostatic hyperplasia. 120 patients: Study arm- min. 80 patients Placebo arm- min. 40 patients Final Aim for Stat. Sig.: 75% of recruitment group (90 patients) Duration - 12 weeks with 3 visits: 0,6,12 weeks 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. dosage: 1 capsule twice daily (morning & evening) can be taken with or without food

Official Title
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A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions
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BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)

Intervention / Treatment
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* Dietary Supplement: BRIZO
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study arm- min. 80 patients Placebo arm- min. 40 patients
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brizo SC012<br>A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING. | Dietary Supplement: BRIZO<br>* A capsule containing 400 mg. SC012 (unique soy extract)<br>|
| Placebo Comparator: PLACEBO<br>A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING. | Other: placebo<br>* Comprecel microcrystalline cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved index in the IPSS test | Improvement by 3 points and with a significance of P< 0.05. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve UROFLOWMETRY test | Improve from personal baseline in UROFLOWMETRY test at Week 12 . | 12 WEEKS |