The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266418
• Other study ID #: 201911062RSA
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: TCI Co., Ltd.
• Contact: Shyr-Chyr Chen
• Phone: (02) 23123456
• Email: scchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male aged 40-80 years old

2. 7 = IPSS score <19

3. The subject did not take a-blocker or anticholinergic agents in the last 8 weeks. The subject did not take 5a-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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Dietary Supplement:
• Placebo
consume 1 sachet per day for 2 months
• Banana flower stamens extract
consume 1 sachet per day for 2 months

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Prostate volume	To measure the volume of prostate measured by ultrasound	Change from baseline prostate volume at 8 weeks
Secondary	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
Secondary	Post-voiding residual urine	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.	Change from baseline post-voiding residual urine at 8 weeks
Secondary	Maximum flow rate	To determine peak urine flow rate and average urine flow rate (mL/sec).	Change from baseline maximum flow rate at 8 weeks