The Effect of BRIZO on Lower Urinary Tract Symptoms (LUTS) Related to Benign Prostatic Hypertrophy (BPH)
NCT ID: NCT05227508
Last Updated: 2022-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-08-31
2024-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Placebo arm- min. 40 patients
TREATMENT
TRIPLE
Study Groups
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Brizo SC012
A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.
BRIZO
A capsule containing 400 mg. SC012 (unique soy extract)
PLACEBO
A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.
placebo
Comprecel microcrystalline cellulose
Interventions
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BRIZO
A capsule containing 400 mg. SC012 (unique soy extract)
placebo
Comprecel microcrystalline cellulose
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
50 Years
MALE
No
Sponsors
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Clalit Health Services
OTHER
Se-cure Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ohad Shoshani, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin Medical Center - Clalit Health Services
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0615-21-RMC
Identifier Type: -
Identifier Source: org_study_id
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