| CTRI Number |
CTRI/2010/091/006143 [Registered on: 11/01/2011] |
| Last Modified On: |
18/02/2013 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| 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 |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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 |
|
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 |
|
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Primary Sponsor
|
| Name |
National Brain Research Centre, Manesar, Gurgaon |
| Address |
|
| 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 |
|
|
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 |
|
| Age To |
|
| Gender |
|
| Details |
Children > 3 years old and adults with suspected encephalitis |
|
| ExclusionCriteria |
| Details |
women of child bearing age (16-44 years) |
|
|
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 |
|
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
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
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|