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临床试验/CTRI/2024/12/078773
CTRI/2024/12/078773尚未招募2 期

Evaluation of efficacy of add on oral ribavirin in children with acute viral encephalitis aged 1-18 years: an open labelled randomized controlled trial

Dr Prateek Kumar Panda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Survival without severe disability

研究概览

简要总结

This open-labeled randomized controlled trial will compare the efficacy of add-on oral ribavirin in children aged 1-18 years, with viral encephalitis. The intervention group will receive add-on oral ribavirin for seven days. The control group will receive only intravenous acyclovir for seven days. We will compare the survival rate without severe disability and the duration of hospitalization in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children with diagnosis of viral encephalitis.

排除标准

  • Children with chronic major systemic illness Previous documented allergy to ribavirin.

结局指标

主要结局

Survival without severe disability

时间窗: At 3 months after randomization

次要结局

  • Cognition of each participant as measured by the Vineland Social Maturity Scale(At 3 months follow up after completing the seven day course of study medication)

研究者

发起方
Dr Prateek Kumar Panda
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prateek Kumar Panda

All India Institute of Medical Sciences, Rishikesh

研究点 (1)

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