Phase 3 Study of a Standardized Pollen Extract Preparation (Cernilton) in Patients With Inflammatory Chronic Prostatitis-chronic Pelvic Pain Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
研究概览
简要总结
In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was investigated. The purpose of this study is to determine whether Cernilton is safe and effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
详细描述
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess safety and efficacy of Cernilton, a standardized pollen extract, in men with inflammatory CP-CPPS (National Institutes of Health (NIH) type IIIA). Participants were randomized to Cernilton or placebo for 12 weeks and were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) individual domains and total score, the number of leukocytes in post prostatic massage urine, the International Prostate Symptom Score (IPSS) and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •men between 18 and 65 years
- •symptoms of pelvic pain for at least 3 months during the 6 months before study entry
- •a score in the pain domain of the German validated version of the NIH chronic prostatitis symptom index (NIH-CPSI) of 7 or higher
- •leukocytes of 10 or more in post prostate massage urine
排除标准
- •urinary tract infection
- •acute bacterial or chronic bacterial prostatitis
- •history of urethritis with discharge 4 weeks prior to study entry
- •a history of epididymitis or sexually transmitted disease
- •residual urine volume of more than 50 mL due to bladder outlet obstruction
- •indication for or history of prostate surgery including prostate biopsy
- •treatment with phytotherapeutic agents
- •alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks prior to study entry
- •treatment with agents influencing intraprostatic hormone metabolism 6 months prior to study entry
研究组 & 干预措施
Cernilton
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
干预措施: Cernilton (Drug)
Placebo
Men with inflammatory chronic prostatitis-chronic pelvic pain syndrome (CP-CPPS)
干预措施: Placebo (Drug)
结局指标
主要结局
Symptomatic Improvement in the Pain Domain of National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)
时间窗: 0, 6, 12 weeks
Decrease in NIH-CPSI pain score. Best value: 0. Worst value: 21.
次要结局
- Secondary Outcomes Were Symptomatic Improvement of the NIH-CPSI Total Score, the Micturition and Life Quality Domains of the NIH-CPSI Questionnaire, Decrease in the Number of Leukocytes in Urine.(0, 6, 12 weeks)