CTRI/2020/04/024721已完成2 期
A randomized non inferiority trial to compare the efficacy of Racecadotril versus Loperamide in acute radiation enteritis.
IMRF0 个研究点目标入组 162 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
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
- •Histologically proven abdominal and pelvic malignancy without metastases beyond the regional lymph nodes receiving pelvic radiation treatment developing Grade 2 or 3 acute radiation as per Common Toxicity criteria version 4.0 enteritis.
- •Karnofsky performance status > 60.
- •Absence of fever with white blood cell count of between 3,000 - 11,000/mm3
排除标准
- •Patients with grade 4 acute radiation enteritis as per Common Toxicity criteria version 4.0.
- •Patients with blood in stools.
- •Uncontrolled diabetes and hypertension.
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