Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
MALE
Healthy Volunteers
ID04266418

Evaluation of Banana Flower Stamens Extract for Preventing Benign Prostatic Hyperplasia in Adult Men

Led by TCI Co., Ltd. · Updated on 2025-01-09

50

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of banana flower stamens extract on preventing benign prostatic hyperplasia (BPH) in adult men. This double-blind, randomized study focuses on men aged 40 to 80 years with mild to moderate symptoms, assessing changes in urinary symptoms and prostate size over time. Participants will be assigned to consume either a sachet of banana flower stamens extract or a placebo daily for two months. Both groups follow the same dosing schedule, taking their assigned supplement every day during this period. The study carefully monitors clinical signs of BPH and collects questionnaire data at each visit. Throughout the study, doctors evaluate symptoms using the International Prostate Symptom Score (IPSS) and measure prostate volume to track changes from the start of the trial. Questionnaires are completed at each visit to monitor participants' experiences. Safety and symptom improvements are closely observed over the two-month treatment period.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 40 to 80 years old
  • International Prostate Symptom Score (IPSS) between 7 and less than 19
  • No use of alpha-blockers or anticholinergic agents in the last 8 weeks
  • No use of 5-alpha-reductase inhibitors or androgen suppression agents in the last 16 weeks
  • No diagnosis of cancer
  • Able to read and complete the study questionnaires
  • Signed informed consent form after full explanation of the study
Not Eligible

You will not qualify if you...

  • History of epilepsy, convulsions, liver or kidney disease, cancer, endocrine disease, mental illness, alcohol or drug abuse, or other major organic diseases
  • Urinary symptoms not related to prostate enlargement
  • Residual urine volume greater than 250 mL
  • Previous pelvic radiation therapy or pelvic surgery (excluding prostate slice)
  • Use of sexual hormone preparations (LHRH agonists, anti-androgens, feminine agents, or Penta-reductase inhibitors) within 16 weeks prior to the trial
  • Participation in other clinical trials within 12 weeks prior to the trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 114

Actively Recruiting

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Research Team

S

Shyr-Chyr Chen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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