CTRI/2010/091/001096已完成3 期
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Ulinastatin versus placebo alongwith standard supportive care in subjects with mild or severe acute pancreatitis.
Bharat Serums and Vaccines Ltd0 个研究点目标入组 150 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
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
- •I. Age >18years <70years (both inclusive)
- •II. Any two of the following three should be present:
- •1. Abdominal pain characteristic of acute pancreatitis
- •2. Serum amylase and/or lipase ≥ 3 times the upper
- •limit of normal
- •3. Characteristic findings of acute pancreatitis on USG, contrast-enhanced CT or MRI
排除标准
- •1. Pregnancy or breast-feeding
- •2. Evidence of chronic pancreatitis on imaging
- •(calcification, ductal irregularity or dilatation)
- •3. Subjects requiring immediate surgery
- •4. Moribund state in which death was perceived to be
- •imminent ( ≤ 24 hours)
- •5. Participation in another investigational study within
- •30 days before the current study.
研究者
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