- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00216268
Treatment of Japanese Encephalitis
February 8, 2006 updated by: Indian Council of Medical Research
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.
Study Overview
Study Type
Interventional
Enrollment
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rashmi Kumar, MD
- Phone Number: 91-522-2374777
- Email: rashmik2005@gmail.com
Study Locations
-
-
UP
-
Lucknow, UP, India, 226003
- Recruiting
- King George Medical University
-
Contact:
- Rashmi Kumar, MD
- Phone Number: 91-522-2257377
- Email: rashmik2005@gmail.com
-
Principal Investigator:
- Rashmi Kumar, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Mortality during hospital stay
|
Secondary Outcome Measures
Outcome Measure |
---|
Duration of hospital stay
|
Sequelae at 3 months
|
Days to return to oral feeds
|
Days to become convulsion free
|
Days to become afebrile
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rashmi Kumar, King George Medical University, Lucknow INDIA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion
May 1, 2008
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 9, 2006
Last Update Submitted That Met QC Criteria
February 8, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- 5/8/7/1/13/2001-ECD1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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