| CTRI Number |
CTRI/2025/08/092746 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on the Use of Tongue Swab Samples to Detect TB in Children Using a Molecular Test |
|
Scientific Title of Study
|
Utility of Tongue Swab in Diagnosis of Pulmonary Tuberculosis In Children Using Nucleic Acid Amplification test. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Department of Paediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Department of Paediatrics Maulana Azad Medical College and Associated LOK Nayak Hospital
New Delhi
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
7484843491 |
| Fax |
|
| Email |
docashish825@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Anurag Agarwal |
| Designation |
Associate professor |
| Affiliation |
Department of Paediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Department of Paediatrics Maulana Azad Medical College and Associated LOK Nayak Hospital
New Delhi
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Department of Paediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Department of Paediatrics Maulana Azad Medical College and Associated LOK Nayak Hospital
New Delhi
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
07484843491 |
| Fax |
|
| Email |
docashish825@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Maulana Azad Medical College
New Delhi
DELHI
110002
India |
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics Maulana Azad Medical College |
| Address |
Department of Paediatrics Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi
DELHI
110002
India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Kumar Yadav |
Lok Nayak Hospital |
Room No.516
Pediatrics OPD Fifth
Floor, OPD Building
Maulana Azad Medical
college and Associated
Lok Nayak Hospital.
New Delhi
DELHI
Central
DELHI |
07484843491
docashish825@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals(Lok Nayak, GB Pant Institute Post Graduate Medical Education (GIPMER) and Research hospital, Guru nanak Eye Centre, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A159||Respiratory tuberculosis unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Persistent fever without a known cause and Unremitting cough more than 2 weeks
Weight loss of 5 percentage or no weight gain in the past 3 months despite adequate nutrition or failure of nutritional rehabilitation in baby with SAM
With or without contact with patient with pulmonary TB in past 2 years |
|
| ExclusionCriteria |
| Details |
Children who received Antitubercular Therapy For more than 72 hours .
Children who can expectorate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of cases who are found to be positive on Tongue swab testing using Rapid cell Lysis System True lyse tm and NAAT True NAT MTB ultima among presumptive cases of pulmonary TB. |
within 24 hours of sample processing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensitivity & specificity of GA CBNAAT & GA Truenat Using MGIT as gold standard .
To compare sensitivity & specificity of Tonque swab NAAT against GA NAAT
|
within 24 hours of sample processing |
|
|
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)
|
19/08/2025 |
| 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 an observational diagnostic study evaluating the utility of tongue swabs in diagnosing pulmonary tuberculosis (PTB) in children using nucleic acid amplification tests (NAAT) such as Truenat. The study involves collecting tongue swab samples along with routine clinical samples (like gastric aspirates) from children with presumptive PTB. The results of NAAT performed on tongue swabs will be compared with standard diagnostic methods to assess sensitivity, and specificity. |