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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia (BPH)
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Banana flower stamens extract

• Registration Number: NCT04266418
• Lead Sponsor: TCI Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-12
• Study Start: 2023-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	consume 1 sachet per day for 2 months
Banana flower stamens extract	Banana flower stamens extract	consume 1 sachet per day for 2 months

Primary Outcome Measures

Name	Time	Method
Change in International Prostate Symptom Score (IPSS)	Change from baseline IPSS at 4 weeks and 8 weeks	To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.
Change in Prostate volume	Change from baseline prostate volume at 8 weeks	To measure the volume of prostate measured by ultrasound

Secondary Outcome Measures

Name	Time	Method
Post-voiding residual urine	Change from baseline post-voiding residual urine at 8 weeks	To measure and compare the amount of urine left in the bladder after urination before and after treatment. Post-voiding residual urine measured by catheterization or non-invasively by ultrasonography.
International index of erectile function (IIEF)	Change from baseline IIEF at 4 weeks and 8 weeks	To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.
Maximum flow rate	Change from baseline maximum flow rate at 8 weeks	To determine peak urine flow rate and average urine flow rate (mL/sec).

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan