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CTRI Number  CTRI/2023/04/052146 [Registered on: 28/04/2023] Trial Registered Prospectively
Last Modified On: 12/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare number of healthy household contacts aged between 6 to 18 years developing TB disease with tor without TB prophylactic therapy. 
Scientific Title of Study   Effectiveness of Tuberculosis Preventive Therapy on Healthy Household Contact- An Open Label Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poulomi Roy 
Designation  Junior Resident 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Pediatrics, 2nd floor,Eras Lucknow Medical College and Hospital, Lucknow

Lucknow
UTTAR PRADESH
2266003
India 
Phone  8599825218  
Fax    
Email  poulomiroy29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetika Srivastave 
Designation  Professor 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Pediatrics, 2nd floor, Eras Lucknow Medical College and Hospital, Lucknow

Lucknow
UTTAR PRADESH
2266003
India 
Phone  9721066555  
Fax    
Email  geetikasri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Poulomi Roy 
Designation  Junior Resident 
Affiliation  Eras Lucknow Medical College and Hospital 
Address  Department of Pediatrics, 2nd floor, Eras Lucknow Medical College and Hospital, Lucknow

Lucknow
UTTAR PRADESH
2266003
India 
Phone  8599825218  
Fax    
Email  poulomiroy29@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr Poulomi Roy 
Address  Eras Lucknow Medical College and Hospital, Lucknow 
Type of Sponsor  Other [Other (self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
POULOMI ROY  Era Lucknow Medical College and Hospital   IPD, Department of Pediatrics, 3rd Floor, Eras Lucknow Medical College
Lucknow
UTTAR PRADESH 
8599825218

poulomiroy29@gmail.com 
Dr Poulomi Roy  Eras Lucknow Medical College and Hospital  OPD,Department of Pediatics, 1st floor, Eras Lucknow Medical College and Hospital Lucknow
Lucknow
UTTAR PRADESH 
8599825218

poulomiroy29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee eras Lucknow medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  children 6-18 years, who are healthy household contacts of people with bacteriologically confirmed TB 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Healthy contacts receiving preventive therapy  Healthy contacts receiving 6 months of isoniazid @10mg/kg/dose as preventive therapy 
Comparator Agent  Healthy Household Contacts not receiving treatment  No signs of TB infection or disease and will not be given any preventive therapy 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children 6-18 years of age who are healthy household contacts of people with bacteriologically confirmed pulmonary TB 
 
ExclusionCriteria 
Details  Children in contact with adults having Multidrug resistant TB or Extensively drug resistant TB  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
We will compare the proportion of healthy household contacts aged 6-18 years developing TB over 9 months after receiving 6 months INH vs no TB preventive therapy  Baseline, 2 weeks, 2 months, 4 months, 6 months and 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
we will compare the proportion of healthy household contacts developing TBI  9 MONTHS 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   31/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Effectiveness of Tuberculosis Preventive Therapy on Healthy Household contact 
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