CTRI Number |
CTRI/2010/091/006143 [Registered on: 11/01/2011] |
Last Modified On: |
18/02/2013 |
Post Graduate Thesis |
|
Type of Trial |
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Type of Study
|
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Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Randomised Double Blind Controlled Trial of Minocycline in Japanese encephalitis |
Scientific Title of Study
Modification(s)
|
Randomised Double Blind Controlled Trial of Minocycline in Japanese encephalitis |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rashmi Kumar |
Designation |
|
Affiliation |
|
Address |
Department of Pediatrics CSM Medical University Lucknow UTTAR PRADESH 226003 India |
Phone |
0522-2322577 |
Fax |
|
Email |
rashmik2005@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
Rashmi Kumar |
Designation |
|
Affiliation |
|
Address |
Department of Pediatrics CSM Medical University Lucknow UTTAR PRADESH 226003 India |
Phone |
0522-2322577 |
Fax |
|
Email |
rashmik2005@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Rashmi Kumar |
Designation |
|
Affiliation |
|
Address |
Department of Pediatrics CSM Medical University Lucknow UTTAR PRADESH 226003 India |
Phone |
0522-2322577 |
Fax |
|
Email |
rashmik2005@gmail.com |
|
Source of Monetary or Material Support
|
National Brain Research Centre, Manesar, Gurgaon |
|
Primary Sponsor
|
Name |
National Brain Research Centre, Manesar, Gurgaon |
Address |
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Type of Sponsor |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rashmi Kumar |
Department of Pediatrics |
CSM Medical University,Chowk-226003 Lucknow UTTAR PRADESH |
0522-2322577
rashmik2005@gmail.com |
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Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
CSMMU Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Japanese encephalitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Minocycline |
5 mg/kg followed by 2.5 mg/kg 12 hourly for 7 dauys; 200 mg followed by 100 mg 12 hourly in adults |
Comparator Agent |
Placebo |
same as for drug |
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Inclusion Criteria
|
Age From |
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Age To |
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Gender |
|
Details |
Children > 3 years old and adults with suspected encephalitis |
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ExclusionCriteria |
Details |
women of child bearing age (16-44 years) |
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Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Cumulative Mortality at 3 months from onset |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
? Number of days since randomization for fever to subside.
? Number of days since randomization to come to oral feeding
? Number of days since randomization to return to full consciousness (Glasgow Coma Scale of 15)
? Number of days in hospital since randomization
? Neurological deficits or abnormalities of tone or posture or movement at discharge.
? Neurologic deficits, frank mental retardation or other symptoms such as epilepsy at follow up at 6 months
|
3 months |
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Target Sample Size
Modification(s)
|
Total Sample Size="144" Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/08/2012 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
29/08/2012 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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