Benign Prostatic Hyperplasia (BPH)NCT04266418
The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
A study testing Banana flower stamens extract in people with Benign Prostatic Hyperplasia (BPH), run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Banana flower stamens extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 20 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults
Read the 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)
- Being tested
- Placebo, Banana flower stamens extract
- Keywords
- Banana flower extract, Banana stamen extract, Prostate health
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
consume 1 sachet per day for 2 months
Banana flower stamens extractDietary supplement
Also called Happy Angel Banana Stamen Extract
consume 1 sachet per day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | consume 1 sachet per day for 2 months Receives: Dietary Supplement: Placebo |
| Banana flower stamens extract | Experimental | consume 1 sachet per day for 2 months Receives: Dietary Supplement: Banana flower stamens extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline prostate volume at 8 weeks
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline Bioavailable testosterone at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Mar 2023
- Primary completion30 Apr 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kuo-How Huang, Doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266418
- Sponsor's protocol ID
- 201911062RSA
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2020
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
- ClinicalTrials.gov ID
- NCT04266418
- Acronym / sponsor ID
- 201911062RSA
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Banana flower extract, Banana stamen extract, Prostate health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboconsume 1 sachet per day for 2 months |
| Banana flower stamens extract | Experimental | Dietary Supplement: Banana flower stamens extractconsume 1 sachet per day for 2 months |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboconsume 1 sachet per day for 2 months | Dietary supplement | Placebo |
| Banana flower stamens extractAlso: Happy Angel Banana Stamen Extractconsume 1 sachet per day for 2 months | Dietary supplement | Banana flower stamens extract |
Primary outcome
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 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
11 secondary outcomes
International index of erectile function (IIEF)
Time frame: 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
Average flow rate
Time frame: Change from baseline Average flow rate at 8 weeks
Voided volume
Time frame: 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
The change of inflammatory biomarker High Sensitive C-Reactive Protein (hs-CRP)
Time frame: 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
The change of 5α-Dihydrotestosterone (DHT) levels
Time frame: Change from baseline DHT at 8 weeks
The change of Total testosterone levels
Time frame: Change from baseline Total testosterone at 8 weeks
The change of Free testosterone levels
Time frame: Change from baseline Free testosterone at 8 weeks
The change of Bioavailable testosterone levels
Time frame: Change from baseline Bioavailable testosterone at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuo-How Huang, Doctor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Banana flower stamens extract in people with Benign Prostatic Hyperplasia (BPH), run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Change from baseline IPSS at 4 weeks and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.