Research on Benefit of Umooze as Add-on Therapy in Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
研究概览
简要总结
To evaluate the improvement in symptoms of Benign Prostatic Hyperplasia (BPH) according to the Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze twice daily administration for 56 days in patients with BPH.
详细描述
The study product, Umooze, contain Astragalus radix extracts and Soy extracts as the combination of 960:40 in one 500 mg tablet. Umooze is sold in the market as food. The objective of this study is to evaluate the benefit of Umooze as add- on therapy in BPH, by evaluation the improvement in symptoms of BPH assessed according to the International Prostate Symptom Score (IPSS) and Quality- of- Life (QoL) index after add- on therapy of Umooze in patients with BPH. The IPSS is a validated 7-item urinary symptom severity scale.
A randomized, two-regimen, placebo-controlled, parallel- design is used in this study in which each subject will receive Umooze or placebo. The add- on study product will be administered twice daily for 56 days. Benefit will be evaluated at baseline and subsequently on the study day 28, 42, and 56, such as IPSS index, QoL index, Qmax, PVR, prostate volume and Prostate-specific antigen(PSA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged >=40 years old
- •Screened by inquiry and diagnosed as BPH based on the result of a digital rectal examination (DRE) or transrectal ultrasonography (TRUS)
- •Prostate volume >= 20 cm3
- •Has complained of voiding symptoms related to BPH
- •Has an IPSS >= 13 or an UFR measure of Qmax <= 15 ml/sec together with a voided volume >= 150 ml.
- •Serum PSA < 6.5 ng/ml
- •Has been treated with medication for BPH
- •Informed consent form signed.
排除标准
- •Sensitivity to study product
- •Had received prostatic surgery for BPH during the past 24 weeks
- •Hard nodule found by DRE
- •Ongoing neurogenic bladder, urinary tract infection, bladder stone, urethral stricture, bladder cancer, prostate cancer, severe liver dysfunction, severe renal dysfunction or severe cardiovascular disease.
- •Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co- investigator.
- •Participation of any clinical investigation during the last 30 days.
- •Individuals are judged by the investigators or co- investigator to be undesirable as subjects.
结局指标
主要结局
International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months
时间窗: 56 days
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge
时间窗: 56 days
The Quality of Life (QoL) is a single question with scores of 0\~6 point and corresponding to the assessment index ranging from delighted to terrible.
International Prostate Symptom Score (IPSS)
时间窗: 56 days
It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.
Quality- Of- Life Index (QoL)
时间窗: 56 days
The QoL index is a single question with scores of 0\~6 point and corresponding to the assessment index ranging from delighted to terrible.
次要结局
- Postvoid Residual Volume (PVR)(56 days)
- Prostate Volume(56 days)
- Prostate-specific Antigen (PSA) Level(56 days)
- Maximum Flow Rate (Qmax)(56 days)