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

Se-cure Pharmaceuticals

Status: Enrolling

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

Treatments: Dietary Supplement: BRIZO; Other: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05227508

0615-21-RMC

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Brizo SC012

Experimental group

Description:

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

Treatment:

Dietary Supplement: BRIZO

PLACEBO

Placebo Comparator group

Description:

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

Treatment:

Other: placebo