CTRI/2014/01/004366已完成4 期
Evaluation of the effectiveness and safety of silodosin incomparison to tamsulosin in benign prostatic hyperplasia.
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- •Male subjects above 50 years age
- •History of prostate symptoms for at least 6 months
- •International prostate symptom score (IPSS) at presentation > 7
- •Diagnosis of BPH confirmed by a baseline ultrasonographic scan.
- •Willing to provide written informed consent
- •Willing to comply with the trial protocol.
排除标准
- •Subject judged to have severe bladder neck obstruction, in imminent need of surgery.
- •History of carcinoma prostate.
- •History of urethral stricture.
- •History of acute retention of urine.
- •History of active urinary tract disease or history of cystoscopy or biopsy from the urinary
- •tract within past 2 weeks.
- •History of failed surgery for BPH (including failed transurethral resection of prostate) for
- •any reason.
- •History of treatment with any medication known to influence prostate function within
- •past 1 month (including estrogenic and androgenic agents).
- •History of persistently low blood pressure ( < 90 mmHg systolic and / or < 60 mmHg
- •diastolic) or history of syncopal attacks.
- •Serious disease of vital organs like heart, liver, kidneys or bone marrow.
- •History of alcohol or substance abuse.
- •History of treatment with any herbal remedies within past 1 month.
- •Participation in any other clinical trial within past 3 months.
- •Any other condition, which in the opinion of the investigators, is not conducive to inclusion of the subject in the trial.
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