CTRI/2018/12/016724已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •At screening, subject has a
- •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
研究者
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