A randomized, double-blind, placebo-controlled, parallel-group, single center clinical study to evaluate the efficacy and safety of VISPO in comparison with SPO and placebo in the treatment of benign prostate hyperplasia and male menopause
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 2.IPSS score
研究概览
简要总结
This is a double blind, randomized (1:1:1), placebo controlled, parallel group, three arm, single center study. Elderly male subjects meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study.After passing the eligibility criteria, subjects will be randomized into 3 treatment arms to receive VISPO or SPO or placebo ) in 1:1:1 ratio. The study is planned to be conducted in 3 visits over a period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •At screening, subject has a 1IPSS > 7 2AMS score ≥ 27 3ADAM questionnaire items 1 or 7 or any other questions as positive 4Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1Has a history of prostate cancer or carcinoma of the prostate or, 2Subjects with known history of serum PSA concentration > 4 ng/ml must have prostate cancer ruled out to the satisfaction of the investigator.
- •3Has a residual void volume > 250 mL 4History of Neurogenic bladder dysfunction, Has bladder neck contracture or urethral stricture,Has acute or chronic prostatitis or urinary tract infection, Serious medical co-morbidity, Haematuria diabetes; any prior surgery which could induce dysuria, Use of any other herbal medications for treatment of BPH, associated symptoms and Erectile Dysfunction in past 1 month,Diuretics or drugs with antiandrogenic or alpha-receptor properties in the preceding 3 months.
- •5Subjects allergic to herbal products or any component of the study product 6Known HIV or Hepatitis B positive or any other immuno-compromised state 7Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 8Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
2.IPSS score
时间窗: Day 0, Day 42, Day 84
Change in the following parameter from baseline to end of treatment
时间窗: Day 0, Day 42, Day 84
1.Post-voidal residual volume of urine
时间窗: Day 0, Day 42, Day 84
3. ADAM questionnaire score
时间窗: Day 0, Day 42, Day 84
4.AMS score
时间窗: Day 0, Day 42, Day 84
次要结局
- Change in(1.Uroflowmetry parameters)