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临床试验/NCT00216268
NCT00216268Unknown2 期

Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

Indian Council of Medical Research2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年7月最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
200
试验地点
2
主要终点
Mortality during hospital stay

研究概览

简要总结

Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
6 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child between 6 months and 12 years age
  • Acute febrile encephalopathy
  • Positive IgM ELISA test for Japanese encephalitis in serum

排除标准

  • Consent not obtained

结局指标

主要结局

Mortality during hospital stay

次要结局

  • Sequelae at 3 months
  • Duration of hospital stay
  • Days to return to oral feeds
  • Days to become convulsion free
  • Days to become afebrile

研究者

申办方类型
Other Gov

研究点 (2)

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