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

TCI

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Banana flower stamens extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT04266418

201911062RSA

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

consume 1 sachet per day for 2 months

Treatment:

Dietary Supplement: Placebo

Banana flower stamens extract

Experimental group

Description:

consume 1 sachet per day for 2 months

Treatment:

Dietary Supplement: Banana flower stamens extract