FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090828 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 12/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Capacity Building Project 
Study Design  Other 
Public Title of Study   Cystic Fibrosis India Expansion Project: Improving Diagnosis and Care for Children with Cystic Fibrosis in Hospitals Across South India 
Scientific Title of Study   Cystic Fibrosis–India Expansion Project: Expanding and Establishing CF Diagnostics and Clinical Care in Secondary Medical Centers in South India. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneha Deena Varkki 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Paediatric Unit 3 Office ISSCC Building
Ida Scudder Road, Christian Medical College
Vellore
TAMIL NADU
632004
India 
Phone  9597076124  
Fax    
Email  snehatitus85@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sneha Deena Varkki 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Paediatric Unit 3 Office ISSCC Building
Ida Scudder Road, Christian Medical College
Vellore
TAMIL NADU
632004
India 
Phone  9597076124  
Fax    
Email  snehatitus85@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sneha Deena Varkki 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Paediatric Unit 3 Office ISSCC Building
Ida Scudder Road, Christian Medical College
Vellore
TAMIL NADU
632004
India 
Phone  04162283343  
Fax    
Email  snehatitus85@yahoo.com  
 
Source of Monetary or Material Support  
Cystic Fibrosis Foundation Grant 4550 Montgomery Ave. Suite 1100N, Bethesda, MD 20814, USA.  
 
Primary Sponsor  
Name  Cystic Fibrosis Foundation 
Address  4550 Montgomery Ave. Suite 1100N, Bethesda, MD 20814, USA 
Type of Sponsor  Other [Non Profit Organisation] 
 
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 Sneha Deena Varkki  Christian Medical College  Department of Paediatrics Unit - 3 ISSCC building - 5th Floor Ida Scudder Road
Vellore
TAMIL NADU 
9597076124

snehatitus85@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board Office of Research Christian Medical College Vellore India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  This project involves teaching how to do diagnostic test for Cystic Fibrosis to the lab staff in Five Centres across India. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  This is not a clinical trial. This is a Capacity building project - To equip Five centres across India.
Inclusion criteria:
Any children with suspected CF or Bronchiectasis for evaluation
Exclusion criteria:
Severe dermatitis  
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This is a service and educational project
1. Participation in the International Mentoring Training Initiative (IMTI) on Online module
2. Purchase and effective use of sweat testing equipment. 
1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
Purchase & effective use of sweat testing equipment.  1 Year 
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
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)   01/08/2025 
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  

This is not a research project. This is a capacity building project funded by the foreign agency. The grant money will be used for purchasing sweat testing equipment, which will be donated to 5 centres across India. The lab staff will be trained to do sweat testing to diagnose CF. This CTRI submission is being done as it was suggested by Health Ministry Screening Committee - The proposal ID 2025-18223 dated 30th June.


Cystic Fibrosis is a life limiting genetic disease which affects people of all races.  It was considered an European disease and very little importance was given to this condition in medical education as well as in hospital practice in India. Diagnostic facility for doing sweat chloride testing -gold standard test for the disease is available only in a handful of centres in India. This leads to mis diagnosis or late diagnosis of CF resulting in severe morbidity and childhood mortality.

 In the last 10 years , significant strides have been made in the care of persons with CF ( pwCF ) in India through coordinated efforts of IAP and many Paediatric pulmonologists in the country. CMC has collaborated with  Nationwide Children’s Hospital, Columbus (NCH) and focused on 1) capacity building, 2) training multidisciplinary teams, 3) enhancing education and awareness on CF among healthcare providers and families, and 4) developing cost-effective treatment strategies. Multiple small CF teams or individual doctors  serve as core clinical and educational resources in South India and regions in Northeast India, achieving meaningful improvements in diagnostic and clinical outcomes despite various socio-economic and infrastructural challenges. Experience from these collaborations have emphasized the need to enhance regional access to testing and treatment for CF by establishing better diagnostic and clinical care centers.


We, therefore, propose the ‘CF-India Expansion’ plan to identify, develop, and equip five secondary medical centers (SMCs) in South India to become skilled CF care centers with educational and diagnostic resources that would enhance regional CF care. Improved access to diagnostic facilities will facilitate earlier diagnosis and help reduce severe CF-related morbidity and mortality, particularly in young children.


The International Mentoring Training Initiative (IMTI), offered by the International CF Training Network, is designed to prepare U.S.-based CF multidisciplinary teams to mentor CF teams in LMIC. Supported by the CFF and led by the CF team at the University of Alabama/Children’s of Alabama, the IMTI program aims to establish a robust infrastructure for local training at CF care centers across LMIC. As the CF-India expansion plan aims to develop secondary medical centers into skilled CF diagnostic and clinical care facilities, it is essential that these teams receive training and mentorship from established and effective CF centers to achieve competence.

 
Close