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

May 26, 2026 updated by: TCI Co., Ltd.
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in International Prostate Symptom Score (IPSS)
Time Frame: 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 from baseline IPSS at 4 weeks and 8 weeks
Change in Prostate volume
Time Frame: Change from baseline prostate volume at 8 weeks
Transrectal ultrasound (TRUS) is utilized to measure the prostate volume. Units: cm^3
Change from baseline prostate volume at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
International index of erectile function (IIEF)
Time Frame: 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.
Change from baseline IIEF at 4 weeks and 8 weeks
Maximum flow rate (Qmax)
Time Frame: Change from baseline maximum flow rate at 8 weeks
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
Time Frame: Change from baseline Average flow rate at 8 weeks
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
Time Frame: Change from baseline Voided volume rate at 8 weeks
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)
Time Frame: Change from baseline Interleukin-6 at 8 weeks
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)
Time Frame: Change from baseline hs-CRP at 8 weeks
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
Time Frame: Change from baseline PSA at 8 weeks
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
Time Frame: Change from baseline DHT at 8 weeks
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
Time Frame: Change from baseline Total testosterone at 8 weeks
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
Time Frame: Change from baseline Free testosterone at 8 weeks
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
Time Frame: Change from baseline Bioavailable testosterone at 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TCI Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kuo-How Huang, Doctor, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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