DRKS00011044已完成未知
Effects of a pumpkin seed powder extract EFLA(R)940, a food supplement, on symptom frequency and severity in men with BPH - BTS996/16
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 75 Years（—）
- 性别
- Male
入选标准
- •Suffering from symptoms of BHP for at least 6 month before screening;
- •PSA <4 ng/mL;
- •IPSS at least 8 at screening;
- •Nocturia: at least 1-2 per night
排除标准
- •History of prostatic surgery or other invasive or minimally invasive procedures to treat BPH;
- •Has other conditions that may cause urinary symptoms (e.g. bladder malignancy, acute or chronic urinary tract infections, etc.);
- •History or evidence of prostate cancer;
- •BMI >40 kg/m2 (Class III obesity);
- •HbA1c >6.5 at screening in non-diabetic subjects, HbA1c >7.5 in subjects under medical treatment of diabetics;
- •Gastrointestinal diseases/conditions;
- •Heavy smoker >15 cigarettes/day;
- •History of surgery of the prostate, bladder or urethra;
- •Use of any other medications or dietary supplements for treatment of BPH, associated symptoms and erectile dysfunction in the past month
研究者
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