Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Banana flower extract, Banana stamen extract, Prostate health
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
consume 1 sachet per day for 2 months
DIETARY_SUPPLEMENTBanana flower stamens extract
consume 1 sachet per day for 2 months
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
Yes
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). * Planned invasive procedures or examinations during the trial period, including prostate surgery, prostate biopsy, cystourethroscopy, pelvic surgery, exploratory laparotomy, or any treatment requiring the use of a urinary catheter. * 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. * History or detection of prostate cancer (e.g., positive tissue biopsy or ultrasound findings, or suspected abnormalities on digital rectal examination \[DRE\]). However, subjects with suspected abnormalities on ultrasound or DRE may participate if they had a negative biopsy within the past 6 months and demonstrate stable Prostate-Specific Antigen (PSA) levels (based on medical history).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Transrectal ultrasound (TRUS) is utilized to measure the prostate volume. Units: cm\^3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Maximum flow rate (Qmax) | Change from baseline maximum flow rate at 8 weeks | Uroflowmetry is utilized to measure the maximum volume of urine voided per second. Units: mL/s |
| Average flow rate | Change from baseline Average flow rate at 8 weeks | Uroflowmetry is utilized to measure the average volume of urine voided per second. Units: mL/s |
| Voided volume | Change from baseline Voided volume rate at 8 weeks | Uroflowmetry is utilized to measure the total volume of urine expelled from the bladder during a single micturition. Units: mL |
| The change of inflammatory biomarker Interleukin-6 (IL-6) | Change from baseline Interleukin-6 at 8 weeks | Electrochemiluminescense immunoassay (ECLIA) is utilized to measure serum Interleukin-6 levels. Units: pg/mL |
| The change of inflammatory biomarker High Sensitive C-Reactive Protein (hs-CRP) | Change from baseline hs-CRP at 8 weeks | Latex Particle Immunoturbidimetric Latex is utilized to measure serum hs-CRP levels. Units: mg/dL |
| The change of Prostate-Specific Antigen (PSA) levels | Change from baseline PSA at 8 weeks | Chemiluminescent immunoassay (CLIA) is utilized to measure serum Prostate-Specific Antigen levels. Units: ng/mL |
| The change of 5α-Dihydrotestosterone (DHT) levels | Change from baseline DHT at 8 weeks | Enzyme-linked immunosorbent assay (ELISA) is utilized to measure serum DHT levels. Units: ng/mL |
| The change of Total testosterone levels | Change from baseline Total testosterone at 8 weeks | Chemiluminescent immunoassay (CLIA) is utilized to measure serum total testosterone levels. Units: ng/mL |
| The change of Free testosterone levels | Change from baseline Free testosterone at 8 weeks | Chemiluminescent immunoassay (CLIA) and calculation methods are utilized to measure serum free testosterone levels. Units: pg/mL |
| The change of Bioavailable testosterone levels | Change from baseline Bioavailable testosterone at 8 weeks | Chemiluminescent immunoassay (CLIA) and calculation methods are utilized to measure serum Bioavailable testosterone levels. Units: ng/mL |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORKuo-How Huang, Doctor
National Taiwan University Hospital
Outcome results
None listed