National Taiwan University Hospital
Taipei, Taiwan, 114
NCT Number: NCT04266418
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults
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Notify Me40 year–80 year
Male
Interventional
Not applicable
Taipei, Taiwan, 114
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
consume 1 sachet per day for 2 months
consume 1 sachet per day for 2 months
Other names: Happy Angel Banana Stamen Extract
Time frame: 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.
Time frame: Change from baseline prostate volume at 8 weeks
Transrectal ultrasound (TRUS) is utilized to measure the prostate volume. Units: cm^3
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline Interleukin-6 at 8 weeks
Electrochemiluminescense immunoassay (ECLIA) is utilized to measure serum Interleukin-6 levels. Units: pg/mL
Time frame: Change from baseline hs-CRP at 8 weeks
Latex Particle Immunoturbidimetric Latex is utilized to measure serum hs-CRP levels. Units: mg/dL
Time frame: Change from baseline PSA at 8 weeks
Chemiluminescent immunoassay (CLIA) is utilized to measure serum Prostate-Specific Antigen levels. Units: ng/mL
Time frame: Change from baseline DHT at 8 weeks
Enzyme-linked immunosorbent assay (ELISA) is utilized to measure serum DHT levels. Units: ng/mL
Time frame: Change from baseline Total testosterone at 8 weeks
Chemiluminescent immunoassay (CLIA) is utilized to measure serum total testosterone levels. Units: ng/mL
Time frame: 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
Time frame: 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
TCI Co., Ltd.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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