A Randomized, Double Blinded, Controlled Clinical Trial of Pomegranate Tablets vs Placebo: Effects on Symptoms of Benign Prostatic Hyperplasia
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patients w/ BPH symptoms will be followed w/ AUA symptom questionnaires & exams; in addition, urinary flow rate & post void residual checks will be done to determine whether patients on pomegranate tablets have a reduction in symptoms.
研究概览
简要总结
To determine whether pomegranate tablets have a therapeutic effect on Benign Prostatic Hyperplasia.
详细描述
Patients with newly diagnosed benign prostatic hyperplasia (BPH) will be recruited from the urology clinic at UCI medical center for this study as indicated in section 4. Once recruited, patients will be randomized into two groups - placebo and pomegranate tablets.
Prior to randomization, there will be a 6 week run-in period in which the basal parameters will be established. The basal parameters include a complete history and physical exam including an AUA symptom questionnaire and men's sexual health questionnaire, urine culture, urinalysis, PSA, serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), serum free testosterone, serum dihydrotestosterone, maximum urinary flow rate (Qmax), post void residual bladder volume, and prostate volume measurement via Trans-rectal ultrasound. Then patients will be randomized either to the study group or to the control group using a random number generator. All of the study subjects will be counseled to take one capsule daily in the morning and not to consume any other prostate supplements, or other forms of medical or herbal therapy for BPH.
Patients will be asked to come in every 2 months for the following tests and questionnaires to be administered:
- AUA Symptoms Score sheet
- Men's Sexual Health Questionnaire
- Urine culture
- Urinalysis
- PSA
- Serum chemistry (sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose)
- Serum free testosterone
- Serum 5-dihydrotestosterone
- Maximum urinary flow rate (Qmax)
- Post void residual check
- Prostate volume measurement via Trans-rectal ultrasound
Maximum blood volume that will be drawn for each blood draw is 10 ml (2 table spoon), and the maximum blood draws per patient is 3 per person if there is no crossover and 6 if there is a crossover. Prior to all blood draw, patients will be asked to refrain from sexual intercourse for at least 48 hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Clinically diagnosed with mild to moderate BPH (AUA symptom score <20)
排除标准
- •Patient with severe BPH (AUA symptom score >21)
- •Currently using any other forms of medical therapy, prescription finasteride, terazosin, tamsulosin or propecia (for hair loss).
- •Prior Transurethral resection of the prostate (TURP).
- •Using non-prescription supplements such as Saw Palmetto, B-sitosterol, vitamin E, and quercetin.
研究组 & 干预措施
Pomegranate Tablet
干预措施: Pomegranate Tablet (Drug)
Placebo Tablet
干预措施: Placebo Tablet (Drug)
结局指标
主要结局
Patients w/ BPH symptoms will be followed w/ AUA symptom questionnaires & exams; in addition, urinary flow rate & post void residual checks will be done to determine whether patients on pomegranate tablets have a reduction in symptoms.
时间窗: Time points in which data is collected are initial visit, two weeks, four weeks, and 2, 4, 6, 8, 10, and 12 months.
次要结局
未报告次要终点