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Treatment of Japanese Encephalitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Indian Council of Medical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT00216268
First received: September 20, 2005
Last updated: February 8, 2006
Last verified: September 2005

September 20, 2005
February 8, 2006
July 2005
Not Provided
Mortality during hospital stay
Same as current
Complete list of historical versions of study NCT00216268 on ClinicalTrials.gov Archive Site
  • Sequelae at 3 months
  • Duration of hospital stay
  • Days to return to oral feeds
  • Days to become convulsion free
  • Days to become afebrile
Same as current
Not Provided
Not Provided
 
Treatment of Japanese Encephalitis
Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Japanese Encephalitis
Drug: Ribavirin
Not Provided
Kumar R, Tripathi P, Baranwal M, Singh S, Tripathi S, Banerjee G. Randomized, controlled trial of oral ribavirin for Japanese encephalitis in children in Uttar Pradesh, India. Clin Infect Dis. 2009 Feb 15;48(4):400-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2008
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • Consent not obtained
Both
6 Months to 12 Years
No
Contact: Rashmi Kumar, MD 91-522-2374777 rashmik2005@gmail.com
India
 
NCT00216268
5/8/7/1/13/2001-ECD1
Not Provided
Not Provided
Indian Council of Medical Research
Not Provided
Principal Investigator: Rashmi Kumar King George Medical University, Lucknow INDIA
Indian Council of Medical Research
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP