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

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Banana flower stamens extract

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 114
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male aged 40-80 years old
• 7 ≤ IPSS score <19
• 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).
• The subject isn't diagnosed with cancer
• The subject is able to read and finish the information on the questionnaire.
• The subject must read and sign the informed consent form after the study has been fully explained.

Exclusion criteria:

• 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).
• The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history).
• Residual urine volume > 250 mL (depending on medical history)
• 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).
• Planned invasive procedures or examinations during the trial period, including prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, exploratory laparotomy, or any treatment requiring the use of a urinary catheter.
• 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.
• Subjects have participated in other clinical trials 12 weeks prior to the trial.
• History or detection of prostate cancer (e.g., positive tissue biopsy or ultrasound findings, or suspected abnormalities on digital rectal examination [DRE]). However, subjects with suspected abnormalities on ultrasound or DRE may participate if they had a negative biopsy within the past 6 months and demonstrate stable Prostate-Specific Antigen (PSA) levels (based on medical history).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; consume 1 sachet per day for 2 months	Dietary supplement: Placebo; consume 1 sachet per day for 2 months
Experimental: Banana flower stamens extract; consume 1 sachet per day for 2 months	Dietary supplement: Banana flower stamens extract; consume 1 sachet per day for 2 months; Other Names: Happy Angel Banana Stamen Extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Prostate Symptom Score (IPSS)	To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.	Change from baseline IPSS at 4 weeks and 8 weeks
Change in Prostate volume	Transrectal ultrasound (TRUS) is utilized to measure the prostate volume. Units: cm^3	Change from baseline prostate volume at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International index of erectile function (IIEF)	To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.	Change from baseline IIEF at 4 weeks and 8 weeks
Maximum flow rate (Qmax)	Uroflowmetry is utilized to measure the maximum volume of urine voided per second. Units: mL/s	Change from baseline maximum flow rate at 8 weeks
Average flow rate	Uroflowmetry is utilized to measure the average volume of urine voided per second. Units: mL/s	Change from baseline Average flow rate at 8 weeks
Voided volume	Uroflowmetry is utilized to measure the total volume of urine expelled from the bladder during a single micturition. Units: mL	Change from baseline Voided volume rate at 8 weeks
The change of inflammatory biomarker Interleukin-6 (IL-6)	Electrochemiluminescense immunoassay (ECLIA) is utilized to measure serum Interleukin-6 levels. Units: pg/mL	Change from baseline Interleukin-6 at 8 weeks
The change of inflammatory biomarker High Sensitive C-Reactive Protein (hs-CRP)	Latex Particle Immunoturbidimetric Latex is utilized to measure serum hs-CRP levels. Units: mg/dL	Change from baseline hs-CRP at 8 weeks
The change of Prostate-Specific Antigen (PSA) levels	Chemiluminescent immunoassay (CLIA) is utilized to measure serum Prostate-Specific Antigen levels. Units: ng/mL	Change from baseline PSA at 8 weeks
The change of 5α-Dihydrotestosterone (DHT) levels	Enzyme-linked immunosorbent assay (ELISA) is utilized to measure serum DHT levels. Units: ng/mL	Change from baseline DHT at 8 weeks
The change of Total testosterone levels	Chemiluminescent immunoassay (CLIA) is utilized to measure serum total testosterone levels. Units: ng/mL	Change from baseline Total testosterone at 8 weeks
The change of Free testosterone levels	Chemiluminescent immunoassay (CLIA) and calculation methods are utilized to measure serum free testosterone levels. Units: pg/mL	Change from baseline Free testosterone at 8 weeks
The change of Bioavailable testosterone levels	Chemiluminescent immunoassay (CLIA) and calculation methods are utilized to measure serum Bioavailable testosterone levels. Units: ng/mL	Change from baseline Bioavailable testosterone at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Kuo-How Huang, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): May 20, 2026

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Banana flower extract; Banana stamen extract; Prostate health
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: 201911062RSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No