Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216268
Status:
UNKNOWN
Last Update Posted:
2006-02-09
First Post:
2005-09-20
Brief Title:
Treatment of Japanese Encephalitis
Sponsor:
Indian Council of Medical Research
Organization:
Indian Council of Medical Research
Study Overview
Official Title:
Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None