Oral Immunoglobulins from Bovine Colostrum and Anti-inflammatory Extracts in Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline
研究概览
简要总结
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a bothering condition characterized by pain localized to the pelvic, perineal and/or genital area and lower urinary tract symptoms (LUTS). Phytotherapy, which involves the combination of two or more active compounds, can be used to treat this challenging condition.
The aim of this study was to investigate the role of an oral combination of colostrum and Serenoa repens extracts (PROSTYM®) in the treatment of CP/CPPS patients. The main questions the present study aims to answer are:
- Does PROSTYM® enhance quality of life of CPP/CPPS patients?
- Does it help reducing pain symptoms of CPP/CPPS patients?
Researchers will investigate whether PROSTYM® works to treat CPP/CPPS symptoms, so its efficacy, but also its tolerability and adherence to therapy.
Participants will:
- Take PROSTYM® every day for 6 months;
- Visit the clinic for follow-up visits at 3 and 6 months;
- Answer validated questionnaires and declare potential adverse events at follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •adult male patients (aged >18 years)
- •clinical affection by CP/CPPS with symptoms that persisted for ≥6 months;
- •CPSI pain domain score ≥5 points;
- •negative Meares and Stamey test score.
排除标准
- •patients with prevalent BPH symptoms (CPSI pain domain <5), acute prostatitis, chronic bacterial prostatitis (positive Meares and Stamey test), prostate or bladder cancer, urethral stenosis or neurological bladder;
- •no other drug or supplement specific to chronic prostatitis in the previous 30 days.
研究组 & 干预措施
PROSTYM®
It is a phytotherapic drug. The composition of PROSTYM® (per capsule) includes bovine colostrum (30 mg), Serenoa extracts (320 mg), glutathione (30 mg), N-acetyl cysteine (20 mg), Ribes nigrum extracts (50 mg), willow extracts (50 mg), zinc (5 mg), selenium (27.5 micrograms), and vitamin E (6 mg). All these components are included in one capsule. The drug is administered for 6 months in a 1 cp/die dosage.
干预措施: oral combination of colostrum and Serenoa repens extracts (PROSTYM®) (Drug)
结局指标
主要结局
Rate of ≥25% Decrease in CPSI Total Score Compared to Baseline
时间窗: 6 months
improvement of CP symptoms
次要结局
- Rate of ≥25% Decrease in CPSI Pain Domain Score Compared to Baseline(6 months)
- Rate of ≥25% Decrease in CPSI QoL Domain Score Compared to Baseline(6 months)
- Total Number of Adverse Events(6 months)
研究者
Mattia Sibona
Urologist, MD
Clinica Urologica Molinette - Città della Saliute e della Scienza