Using banana flower stamens extract to prevent benign prostatic hyperplasia in men

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

This study is testing if taking banana flower stamens extract can help prevent benign prostatic hyperplasia in men.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: TCI Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Taipei)
• Trial ID: NCT04266418 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of banana flower stamens extract in preventing benign prostatic hyperplasia (BPH) in adult males. It is a double-blind, randomized study where participants will consume either the extract or a placebo daily for two months. The clinical diagnosis of BPH will be assessed by a doctor, and participants will complete questionnaires at each visit to monitor their symptoms and progress.

Who should consider this trial

Good fit: Ideal candidates for this study are males aged 40-80 years with mild to moderate symptoms of BPH.

Not a fit: Patients with a history of significant medical conditions or those whose urinary symptoms are not related to prostatic hypertrophy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a natural preventive treatment option for men at risk of developing benign prostatic hyperplasia.

How similar studies have performed: While the use of natural extracts for BPH is an area of interest, this specific approach using banana flower stamens extract is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Kuo-How Huang, Doctor — National Taiwan University Hospital
• Study coordinator: Shyr-Chyr Chen

Conditions Benign Prostatic Hyperplasia