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

Study Overview
=================
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.

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

Conditions
-----------------
Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Banana flower stamens extract


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>consume 1 sachet per day for 2 months | Dietary Supplement: Placebo<br>* consume 1 sachet per day for 2 months<br>|
| Experimental: Banana flower stamens extract<br>consume 1 sachet per day for 2 months | Dietary Supplement: Banana flower stamens extract<br>* consume 1 sachet per day for 2 months<br>|

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 |