Prospective Multicenter Open-label One Arm Trial Investigating a Pumpkin Seed, Isoflavonoid and Cranberry Mix in Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- IPSS
研究概览
简要总结
The aim is to assess the efficacy of a mix of Pumpkin Seed Extract, Soy Germ Isoflavonoids and Cranberry (Novex®) in the management of mild to moderate LUTS in BPH patients. The patients will be evaluated based on the severity of LUTS, urological quality of life, and erectile function.
详细描述
This is a single-arm prospective open-label trial investigating a combination of pumpkin seed, isoflavonoid and cranberry mix in improving LUTS, urological quality of life, and erectile function in BPH patients. The compound will be administered orally two tablets daily for 3 months. Recruited patients will be seen at 3 visits: initial visit (visit 1), 1-month visit (visit 2) and 3-month visit (visit 3) and their data will be collected in a dedicated case report form.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •mild to moderate LUTS due to BPH for at least 6 months at the initial visit
- •no previous therapy or are still symptomatic despite the current use of alpha-blockers
排除标准
- •International Prostate Symptom Score (IPSS) > 19
- •Prostate cancer
- •Urethral stenosis
研究组 & 干预措施
Experimental arm
Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally, for 3 months.
干预措施: Novex (Drug)
结局指标
主要结局
IPSS
时间窗: At 1 and 3 months visits
Change in IPSS
次要结局
- IPSS subscores(At 1 and 3 months visits)
- IIEF-5(At 1 and 3 months visits)
- Rate of ejaculatory dysfunction and orthostatic hypotension(At 1 and 3 months visits)
- uQoL(At 1 and 3 months visits)