The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults

NCT ID: NCT04266418

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2026-02-28

Brief Summary

To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults

Detailed Description

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of benign prostatic hyperplasia (BPH) is evaluated by the doctor. The questionnaires are collected at every visit of the trial.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

consume 1 sachet per day for 2 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Banana flower stamens extract

consume 1 sachet per day for 2 months

Group Type: EXPERIMENTAL

Banana flower stamens extract

Intervention Type: DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Interventions

Placebo

consume 1 sachet per day for 2 months

Intervention Type: DIETARY_SUPPLEMENT

Banana flower stamens extract

consume 1 sachet per day for 2 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Male aged 40-80 years old

2. 7 ≤ IPSS score <19

3. The subject did not take α-blocker or anticholinergic agents in the last 8 weeks. The subject did not take 5α-reductase inhibitor or androgen suppression agents in the last 16 weeks (depending on medical history).

4. The subject isn't diagnosed with cancer

5. The subject is able to read and finish the information on the questionnaire.

6. The subject must read and sign the informed consent form after the study has been fully explained.

Exclusion Criteria

1. The subject has a history of epilepsy or convulsions, liver and kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, and other major organic diseases (depending on medical history).

2. The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history).

3. Residual urine volume > 250 mL (depending on medical history)

4. Subjects have had pelvic radiation therapy or pelvic surgery (including prostate or bladder surgery, but those who only have had a prostate slice can participate in the trial).

5. Subjects have taken sexual hormone preparations including LHRH agonists, anti-androgens, feminine, or Penta-reductase inhibitors (Proscar and Avodart) 16 weeks prior to the trial.

6. Subjects have participated in other clinical trials 12 weeks prior to the trial.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

TCI Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuo-How Huang, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shyr-Chyr Chen

Role: CONTACT

scchen@ntu.edu.tw

(02) 23123456

Facility Contacts

chi fu chiang, Ph.D

Role: primary

Jimmy.Chiang@tci-bio.com

Other Identifiers

201911062RSA

Identifier Type: -

Identifier Source: org_study_id