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CTRI Number  CTRI/2021/01/030409 [Registered on: 12/01/2021] Trial Registered Prospectively
Last Modified On: 06/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To determine the exact dose of rabies immunoglobulin for local wound management of animal bite in children and adolescents. 
Scientific Title of Study   DETERMINATION OF OPTIMAL RABIES IMMUNOGLOBULIN (RIG) VOLUME FOR LOCAL WOUND MANAGEMENT OF ANIMAL BITES IN CHILDREN AND ADOLESCENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pawan Kumar 
Designation  Post Graduation in Pediatrics 
Affiliation  Maulana Azad Medical College New Delhi 
Address  Department of Pediatrics, 2,Bahadur Shah Zafar Marg, Maulana Azad Medical College and Associated Lok Nayak Hospital,New Delhi

Central
DELHI
110002
India 
Phone  8826902576  
Fax    
Email  Pawankhush80@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ANURAG AGARWAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  MAULAN AZAD MEDICAL COLLEGE 
Address  2, Bahadur Shah Zafar Marg, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002

Central
DELHI
110002
India 
Phone  9810409625  
Fax    
Email  doctoranuragagarwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ANURAG AGARWAL 
Designation  ASSOCIATE PROFESSOR 
Affiliation  MAULAN AZAD MEDICAL COLLEGE 
Address  2, Bahadur Shah Zafar Marg, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002

North West
DELHI
110002
India 
Phone  9810409625  
Fax    
Email  doctoranuragagarwal@gmail.com  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  Department of Pediatrics Maulana Azad Medical College 
Address  2, Bahadur Shah Zafar Marg, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 
Type of Sponsor  Government medical college 
 
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 
Pawan Kumar  Animal Bite Clinic  2, Bahadur Shah Zafar Marg, Maulana Azad Medical College and Associated Lok Nayak Hospital, Balmiki Basti, New Delhi, Delhi 110002
Central
DELHI 
8826902576

Pawankhush80@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A829||Rabies, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All the children age between 2 to 18 yrs  reporting to animal bite clinic for the first time. 
 
ExclusionCriteria 
Details  Children who have already received rabies immunoglobulin in any time in the past. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The quantity of RIG infiltrated in relation to the size of the       
wound. 
ONE YEAR 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   18/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Rabies is a viral zoonotic disease.It transmits through infected saliva via bites or scratches
from rabid animals (in particular dogs).Rabies is an invariably fatal disease. An unknown number of humans die of rabies every year
worldwide. News media often estimate 40,000 to 60,000 annual human cases worldwide.
India alone reports approximately 20,000 deaths annually.Rabies immune globulin (RIG) is an essential part of postexposure rabies treatment.It
provides protection against the virus during the first 10–14 days after exposure, and before
endogenous neutralizing antibodies are formed in response to vaccination.RIG, that is
injected into and around the virus inoculation sites,which saves lives. One-half of the RIG
should be injected into the bite wounds and the rest intramuscularly,at a different site than
vaccine.This injection is often performed into the gluteal region; a site which except in the
very lean, contains a thick fat layer.RIG,injected at sites other than the wounds,has any
value in neutralizing virus.HRIG is manufactured from non-UK human blood products. The final formulation is a liquid
and the potency of the material is assessed in international units (IU/ml). The maximum dose
is 20IU/kg, adults and children (all ages), and should not be exceeded as it may inhibit the
immune response to rabies vaccine.
 WHO Expert Committee’s recommendation was changed from intramuscular administration
to one where ‘as much as possible’ of the calculated dose of RIG was to be injected into and
around the wound.The dose was, and remains, calculated on the basis of body weight,
suggesting that these recommendations have been trapped in their own irrational history.
Recognising that dog bites vary in number, size and location, these recommendations allow
RIG to be diluted in saline to ensure there is sufficient volume to inject into all wounds.
Curiously, where the wound is too small to take the whole dose, it is still stated that the
residue is to be inoculated into a distal site, even though it is accepted that this will not result
in a significant circulation antibody level.
so we are conducting this study to find out the optimal dose of rabies immunoglobulin (RIG) volume for local wound management of animal bites in children and adolescents.
 
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