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Completed

NCT Number: NCT04266418

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

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 114

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Dietary Supplement

consume 1 sachet per day for 2 months

Banana flower stamens extract

Dietary Supplement

consume 1 sachet per day for 2 months

Other names: Happy Angel Banana Stamen Extract

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2020
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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