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

NCT04266418 | Completed

• 1 other identifier: 201911062RSA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Banana flower extract; Banana stamen extract; Prostate health

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Change from baseline prostate volume at 8 weeks

Secondary Outcomes (11)

• International index of erectile function (IIEF)

  Change from baseline IIEF at 4 weeks and 8 weeks

• Maximum flow rate (Qmax)

  Change from baseline maximum flow rate at 8 weeks

• Average flow rate

  Change from baseline Average flow rate at 8 weeks

• Voided volume

  Change from baseline Voided volume rate at 8 weeks

• The change of inflammatory biomarker Interleukin-6 (IL-6)

  Change from baseline Interleukin-6 at 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

consume 1 sachet per day for 2 months

Dietary Supplement: Placebo

Banana flower stamens extract

EXPERIMENTAL

consume 1 sachet per day for 2 months

Dietary Supplement: Banana flower stamens extract

Interventions

Placebo DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Placebo

Banana flower stamens extract DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Also known as: Happy Angel Banana Stamen Extract

Banana flower stamens extract

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male aged 40-80 years old
• ≤ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 114, Taiwan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kuo-How Huang, Doctor

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: March 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: May 20, 2026
• Last Updated: May 29, 2026

Record last verified: 2025-01

Locations

TW (1)