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

Last updated: January 8, 2025
Sponsor: TCI Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Treatment

Placebo

Banana flower stamens extract

Clinical Study ID

NCT04266418
201911062RSA
  • Ages 40-80
  • Male
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 inthe 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 beenfully explained.

Exclusion

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 majororganic diseases (depending on medical history).

  2. The lower urinary tract urination symptoms of the subject are not related toprostatic 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 orbladder surgery, but those who only have had a prostate slice can participate in thetrial).

  5. Subjects have taken sexual hormone preparations including LHRH agonists,anti-androgens, feminine, or Penta-reductase inhibitors (Proscar and Avodart) 16weeks prior to the trial.

  6. Subjects have participated in other clinical trials 12 weeks prior to the trial.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 114
    Taiwan

    Active - Recruiting

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