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To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | consume 1 sachet per day for 2 months |
|
| Banana flower stamens extract | Experimental | consume 1 sachet per day for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | consume 1 sachet per day for 2 months |
| |
| 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 | Transrectal ultrasound (TRUS) is utilized to measure the prostate volume. Units: cm^3 | Change from baseline prostate volume at 8 weeks |
| 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 |
| Maximum flow rate (Qmax) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuo-How Huang, Doctor | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | 114 | Taiwan |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Banana flower stamens extract |
| Dietary Supplement |
consume 1 sachet per day for 2 months |
|
|
Uroflowmetry is utilized to measure the maximum volume of urine voided per second. Units: mL/s
| Change from baseline maximum flow rate at 8 weeks |
| Average flow rate | Uroflowmetry is utilized to measure the average volume of urine voided per second. Units: mL/s | Change from baseline Average flow rate at 8 weeks |
| Voided volume | Uroflowmetry is utilized to measure the total volume of urine expelled from the bladder during a single micturition. Units: mL | Change from baseline Voided volume rate at 8 weeks |
| The change of inflammatory biomarker Interleukin-6 (IL-6) | Electrochemiluminescense immunoassay (ECLIA) is utilized to measure serum Interleukin-6 levels. Units: pg/mL | Change from baseline Interleukin-6 at 8 weeks |
| The change of inflammatory biomarker High Sensitive C-Reactive Protein (hs-CRP) | Latex Particle Immunoturbidimetric Latex is utilized to measure serum hs-CRP levels. Units: mg/dL | Change from baseline hs-CRP at 8 weeks |
| The change of Prostate-Specific Antigen (PSA) levels | Chemiluminescent immunoassay (CLIA) is utilized to measure serum Prostate-Specific Antigen levels. Units: ng/mL | Change from baseline PSA at 8 weeks |
| The change of 5α-Dihydrotestosterone (DHT) levels | Enzyme-linked immunosorbent assay (ELISA) is utilized to measure serum DHT levels. Units: ng/mL | Change from baseline DHT at 8 weeks |
| The change of Total testosterone levels | Chemiluminescent immunoassay (CLIA) is utilized to measure serum total testosterone levels. Units: ng/mL | Change from baseline Total testosterone at 8 weeks |
| The change of Free testosterone levels | Chemiluminescent immunoassay (CLIA) and calculation methods are utilized to measure serum free testosterone levels. Units: pg/mL | Change from baseline Free testosterone at 8 weeks |
| The change of Bioavailable testosterone levels | Chemiluminescent immunoassay (CLIA) and calculation methods are utilized to measure serum Bioavailable testosterone levels. Units: ng/mL | Change from baseline Bioavailable testosterone at 8 weeks |
| D052801 |
| Male Urogenital Diseases |