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CTRI Number  CTRI/2010/091/006143 [Registered on: 11/01/2011]
Last Modified On: 18/02/2013
Post Graduate Thesis   
Type of Trial   
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 
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 
 
Primary Sponsor  
Name  National Brain Research Centre, Manesar, Gurgaon 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
NIL   
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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 
 
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    
Brief Summary    
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