Clinical trial NCT04266418: The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
Official title: The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male aged 40-80 years old
2. 7 ≤ IPSS score \<19
3. 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).
4. The subject isn't diagnosed with cancer
5. The subject is able to read and finish the information on the questionnaire.
6. The subject must read and sign the informed consent form after the study has been fully explained.

Exclusion criteria:

1. 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).
2. The lower urinary tract urination symptoms of the subject are not related to prostatic hypertrophy (depending on medical history).
3. Residual urine volume \> 250 mL (depending on medical history)
4. 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).
5. 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.
6. Subjects have participated in other clinical trials 12 weeks prior to the trial.

Primary outcomes:
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Change from baseline IPSS at 4 weeks and 8 weeks
measure: Change in Prostate volume
timeFrame: Change from baseline prostate volume at 8 weeks
Secondary outcomes:
measure: International index of erectile function (IIEF)
timeFrame: Change from baseline IIEF at 4 weeks and 8 weeks
measure: Post-voiding residual urine
timeFrame: Change from baseline post-voiding residual urine at 8 weeks
measure: Maximum flow rate
timeFrame: Change from baseline maximum flow rate at 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Kuo-How Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: