Back to resultsThe Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
Primary Purpose
Benign Prostatic Hyperplasia (BPH)
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
Banana flower stamens extract
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH)
Eligibility Criteria
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).
- 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.
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Banana flower stamens extract
Arm Description
consume 1 sachet per day for 2 months
consume 1 sachet per day for 2 months
Outcomes
Primary Outcome Measures
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 in Prostate volume
To measure the volume of prostate measured by ultrasound
Secondary Outcome Measures
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.
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.
Maximum flow rate
To determine peak urine flow rate and average urine flow rate (mL/sec).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04266418
Brief Title
The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
Official Title
The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
consume 1 sachet per day for 2 months
Arm Title
Banana flower stamens extract
Arm Type
Experimental
Arm Description
consume 1 sachet per day for 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
consume 1 sachet per day for 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Banana flower stamens extract
Intervention Description
consume 1 sachet per day for 2 months
Primary Outcome Measure Information:
Title
Change in International Prostate Symptom Score (IPSS)
Description
To measure the severity of lower urinary tract symptoms. Each item is scored 0-5, yielding a total between 0-35.
Time Frame
Change from baseline IPSS at 4 weeks and 8 weeks
Title
Change in Prostate volume
Description
To measure the volume of prostate measured by ultrasound
Time Frame
Change from baseline prostate volume at 8 weeks
Secondary Outcome Measure Information:
Title
International index of erectile function (IIEF)
Description
To evaluate male sexual function over the past 6 months. Each item is scored 1-5, yielding a total between 5-25.
Time Frame
Change from baseline IIEF at 4 weeks and 8 weeks
Title
Post-voiding residual urine
Description
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.
Time Frame
Change from baseline post-voiding residual urine at 8 weeks
Title
Maximum flow rate
Description
To determine peak urine flow rate and average urine flow rate (mL/sec).
Time Frame
Change from baseline maximum flow rate at 8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shyr-Chyr Chen
Phone
(02) 23123456
Email
scchen@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo-How Huang, Doctor
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chi fu chiang, Ph.D
Email
Jimmy.Chiang@tci-bio.com
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
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