The Evaluation of Banana Flower Stamens Extract on Prevention of Benign Prostatic Hyperplasia in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
To assess the evaluation of banana flower stamens extract on prevention of benign prostatic hyperplasia in adults
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Placebo
consume 1 sachet per day for 2 months
干预措施: Placebo (Dietary Supplement)
Banana flower stamens extract
consume 1 sachet per day for 2 months
干预措施: Banana flower stamens extract (Dietary Supplement)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: 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
时间窗: Change from baseline prostate volume at 8 weeks
Transrectal ultrasound (TRUS) is utilized to measure the prostate volume. Units: cm\^3
次要结局
- Post-voiding residual urine(Change from baseline post-voiding residual urine at 8 weeks)
- International index of erectile function (IIEF)(Change from baseline IIEF at 4 weeks and 8 weeks)
- Maximum flow rate(Change from baseline maximum flow rate at 8 weeks)