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

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Banana flower stamens extract

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shyr-Chyr Chen; Phone Number: (02) 23123456; Email: scchen@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • National Taiwan University Hospital
    • Contact: chi fu chiang, Ph.D; Email: Jimmy.Chiang@tci-bio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 in the 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 been fully explained.

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 major organic diseases (depending on medical history).
2. The lower urinary tract urination symptoms of the subject are not related to prostatic 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 or bladder surgery, but those who only have had a prostate slice can participate in the trial).
5. 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.
6. Subjects have participated in other clinical trials 12 weeks prior to the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; consume 1 sachet per day for 2 months	Dietary supplement: Placebo; consume 1 sachet per day for 2 months
Experimental: Banana flower stamens extract; consume 1 sachet per day for 2 months	Dietary supplement: Banana flower stamens extract; consume 1 sachet per day for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To measure the volume of prostate measured by ultrasound	Change from baseline prostate volume at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline IIEF at 4 weeks and 8 weeks
Post-voiding residual urine	To measure and compare the amount of urine left in the bladder after urination before and after treatment. Post-voiding residual urine measured by catheterization or non-invasively by ultrasonography.	Change from baseline post-voiding residual urine at 8 weeks
Maximum flow rate	To determine peak urine flow rate and average urine flow rate (mL/sec).	Change from baseline maximum flow rate at 8 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Kuo-How Huang, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 201911062RSA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No