Clinical Trial: Treatment of Japanese Encephalitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
Brief Summary: 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.
Detailed Summary:
Sponsor: Indian Council of Medical Research
Current Primary Outcome: Mortality during hospital stay
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Sequelae at 3 months
- Duration of hospital stay
- Days to return to oral feeds
- Days to become convulsion free
- Days to become afebrile
Original Secondary Outcome: Same as current
Information By: Indian Council of Medical Research
Dates:
Date Received: September 20, 2005
Date Started: July 2005
Date Completion: May 2008
Last Updated: February 8, 2006
Last Verified: September 2005
