Clincosm LogoSign in Get a demo

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

Sponsor
Se-cure Pharmaceuticals Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05227508
Collaborator
Clalit Health Services (Other)
120
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: BRIZO
  • Other: placebo
 N/A

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.

  1. dosage: 1 capsule twice daily (morning & evening) can be taken with or without food

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Study arm- min. 80 patients Placebo arm- min. 40 patientsStudy arm- min. 80 patients Placebo arm- min. 40 patients
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-blind, Placebo Controlled, 12-week Treatment Trial in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brizo SC012

A capsule containing 400 mg. SC012 (unique soy extract) TWICE A DAY : MORNING , EVENING.

Dietary Supplement: BRIZO
A capsule containing 400 mg. SC012 (unique soy extract)
Placebo Comparator: PLACEBO

A capsule containing 400 mg OF PLACEBO, TWICE A DAY: MORNING , EVENING.

Other: placebo
Comprecel microcrystalline cellulose

Outcome Measures

Primary Outcome Measures

  1. Improved index in the IPSS test [12 weeks]

    Improvement by 3 points and with a significance of P< 0.05.

Secondary Outcome Measures

  1. Improve UROFLOWMETRY test [12 WEEKS]

    Improve from personal baseline in UROFLOWMETRY test at Week 12 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rabin Medical Center - Clalit Health Services Petach Tikva Israel 4941492

Sponsors and Collaborators

  • Se-cure Pharmaceuticals Ltd.
  • Clalit Health Services

Investigators

  • Principal Investigator: Ohad Shoshani, MD, Rabin Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Se-cure Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT05227508
Other Study ID Numbers:
  • 0615-21-RMC
First Posted:
Feb 7, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Jul 12, 2022