Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
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
- 否
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
