CTRI/2021/08/035595尚未招募不适用
Comparative Study On Efficacy And Safety Of Tamsulosin Vs Silodosin In Patients With Distal Ureteric Calculus Of Size ≤ 10 mm
Arvind Kumar Prabhat1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Which drug ( Tamsulosin or Silodosin) has more efficacy and safety in patients with distal ureteric calculus of size less than or equal to 10 mm
研究概览
简要总结
To compare the efficacy and safety of tamsulosin and silodosin among the subjects with distal ureteric calculus of size less than or equal to 10 mm -
-
Medical expulsion therapy in distal ureteic calculus.
-
Time taken for expulsion of the calculus.
-
Analgesic requirement.
-
Rate of failure of spontaneous distal ureteric calculus expulsion on medical expulsion therapy and need of surgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult subjects coming to Urology OPD with ureteric colic.
- •Unilateral single distal ureteric calculus of size ≤ 10 mm diagnosed on CTKUB plain.
- •Subjects with prior informed consent.
排除标准
- •Subjects who do not want to undergo medical expulsion therapy (MET) and want immediate surgical management.
- •Breastfed and Pregnant women.
- •Subjects with congenital anomalies of genitourinary and gastrointestinal tract.
- •Subjects with fever.
- •Subjects with impaired renal function.
- •Subjects in ICU with urinary sepsis.
- •Lower ureteric calculi size > 10 mm.
- •Calculus in single functioning kidney (SFK).
- •Subjects on hemodialysis.
结局指标
主要结局
Which drug ( Tamsulosin or Silodosin) has more efficacy and safety in patients with distal ureteric calculus of size less than or equal to 10 mm
时间窗: Effect of Medical expulsion therapy ( Tamsulosin or Silodosin ) in terms of expulsion of calculus in patients with distal ureteric calculus of size equal to or less than 10 mm over a duration of 7 days.
次要结局
- To know efficacy and safety of tamsulosin and silodosin as a medical expulsion therapy in patients with distal ureteric calculus of size equal to or less than 10 mm.(Total duration of study - 1 year 6 months)
研究者
研究点 (1)
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