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| Sponsor: | Indian Council of Medical Research |
|---|---|
| Information provided by: | Indian Council of Medical Research |
| ClinicalTrials.gov Identifier: | NCT00216268 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Japanese Encephalitis |
Drug: Ribavirin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | May 2008 |
Eligibility| Ages Eligible for Study: | 6 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Rashmi Kumar, MD | 91-522-2374777 | rashmik2005@gmail.com |
| India | |
| King George Medical University | Recruiting |
| Lucknow, UP, India, 226003 | |
| Contact: Rashmi Kumar, MD 91-522-2257377 rashmik2005@gmail.com | |
| Principal Investigator: Rashmi Kumar, MD | |
| Principal Investigator: | Rashmi Kumar | King George Medical University, Lucknow INDIA |
More Information
| ClinicalTrials.gov Identifier: | NCT00216268 History of Changes |
| Other Study ID Numbers: | 5/8/7/1/13/2001-ECD1 |
| Study First Received: | September 20, 2005 |
| Last Updated: | February 8, 2006 |
| Health Authority: | India: Ministry of Health |
|
Encephalitis Encephalitis, Japanese Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Encephalitis, Arbovirus Arbovirus Infections Encephalitis, Viral |
RNA Virus Infections Flavivirus Infections Flaviviridae Infections Ribavirin Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |