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

Not Applicable

• Conditions: BPH Without Urinary Obstruction and Other Lower Urinary Tract Symptoms (LUTS)
• Interventions: Dietary Supplement: BRIZO; Other: placebo

• Registration Number: NCT05227508
• Lead Sponsor: Se-cure Pharmaceuticals Ltd.

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

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-12
• Study Start: 2022-08
• Primary Completion: 2024-01
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brizo SC012	BRIZO	A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.
PLACEBO	placebo	A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.

Primary Outcome Measures

Name	Time	Method
Improved index in the IPSS test	12 weeks	Improvement by 3 points and with a significance of P\< 0.05.

Secondary Outcome Measures

Name	Time	Method
Improve UROFLOWMETRY test	12 WEEKS	Improve from personal baseline in UROFLOWMETRY test at Week 12 .

Trial Locations

Locations (1)

Rabin Medical Center - Clalit Health Services; 🇮🇱 Petach Tikva, Israel