NCT01021267Unknown4 期
Clinical Pilot Trial on the Influence of a Saw Palmetto Berry Preparation on Sexual Functions in Patients With Benign Prostatic Hyperplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- A. Vogel AG
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of the brief Sexual Function Inventory
研究概览
简要总结
Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
- •IPSS > 4
- •BSFI, sexual drive questions < 5
排除标准
- •Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months
- •Patients with severe vascular disorders (microangiopathies)
- •Patients with known neuropathies
- •Severe diabetes mellitus
- •Patients with hypertension who are for less than two months on a stable antihypertensive medication
- •Known bad compliance of the patient
研究组 & 干预措施
Saw palmetto berry extract
Experimental
Saw palmetto berry extract, organic saw palmetto, ethanolic extract 96%
干预措施: Saw palmetto berry extract (Drug)
结局指标
主要结局
Change of the brief Sexual Function Inventory
时间窗: day 0 and day 56
次要结局
- change in IPSS change in Urolife Quality of Life questionnaire(day 0 and day 56)
研究者
研究点 (1)
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