The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
Study Details
Study Description
Brief Summary
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in International Prostate Symptom Score (IPSS) [Change from baseline IPSS at 4 weeks and 8 weeks]
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 [Change from baseline prostate volume at 8 weeks]
To measure the volume of prostate measured by ultrasound
Secondary Outcome Measures
- International index of erectile function (IIEF) [Change from baseline IIEF at 4 weeks and 8 weeks]
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 [Change from baseline post-voiding residual urine at 8 weeks]
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 [Change from baseline maximum flow rate at 8 weeks]
To determine peak urine flow rate and average urine flow rate (mL/sec).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male aged 40-80 years old
-
7 ≤ IPSS score <19
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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).
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The subject isn't diagnosed with cancer
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The subject is able to read and finish the information on the questionnaire.
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The subject must read and sign the informed consent form after the study has been fully explained.
Exclusion criteria:
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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).
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The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history).
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Residual urine volume > 250 mL (depending on medical history)
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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).
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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.
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Subjects have participated in other clinical trials 12 weeks prior to the trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- TCI Co., Ltd.
Investigators
- Principal Investigator: Kuo-How Huang, Doctor, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201911062RSA