| CTRI Number |
CTRI/2024/11/077107 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study Of Post Tuberculosis Lung Disease In Adults With Drug Sensitive Pulmonary Tuberculosis. |
|
Scientific Title of Study
|
Study Of Post Tuberculosis Lung Disease In Adults With Drug Sensitive Pulmonary Tuberculosis. |
| 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 Rohit Raj |
| Designation |
Post Graduate Medicine Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
B.C Roy Hostel,Maulana Azad Medical College,New Delhi
Central
DELHI
110002
India |
| Phone |
7991193392 |
| Fax |
|
| Email |
epudi01raj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Kumar |
| Designation |
Professor, Department Of Medicine,MAMC,New Delhi |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of General Medicine,B.L Taneja Block,MAMC,New Delhi
Central
DELHI
110002
India |
| Phone |
9953946064 |
| Fax |
|
| Email |
drnareshmamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Kumar |
| Designation |
Professor, Department Of Medicine,MAMC,New Delhi |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of General Medicine,B.L Taneja Block,MAMC,New Delhi
Central
DELHI
110002
India |
| Phone |
9953946064 |
| Fax |
|
| Email |
drnareshmamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMC & Associated Hospitals |
|
|
Primary Sponsor
|
| Name |
Dr Rohit Raj |
| Address |
B.C Roy Hostel,MAMC,New Delhi,110002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rohit Raj |
Department of General Medicine, MAMC and associated Hospitals, Loknayak Hospital |
MAMC and Associated Hospitals, Loknayak Hospital
Central
DELHI |
7991193392
epudi01raj@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A150||Tuberculosis of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ADULTS BETWEEN 18-65 YEARS OF AGE WHO COMPLETED DAILY DRUG REGIMEN FOR DRUG SENSITIVE PULMONARY TUBERCULOSIS AS PER NTEP GUIDELINES. |
|
| ExclusionCriteria |
| Details |
PATIENTS with previously Diagnosed chronic lung pathology like COPD, Asthma,ILD,PAH and Extra pulmonary Tuberculosis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion Of patients of Drug Sensitive Pulmonary Tuberculosis who develop PTLD at the completion of Treatment. |
Proportion Of patients of Drug Sensitive Pulmonary Tuberculosis who develop PTLD at the completion of Treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinico-Radiological and Functional Outcomes of Drug Sensitive Pulmonary Tuberculosis in Adults as per NTEP guidelines at the completion of treatment. |
After completion of treatment as per NTEP guidelines. |
|
|
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)
|
26/11/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
India accounts for more than two third of global TB patients count.With the advancement in Medical Sciences we are able to came with the ways of early diagnosis and effective treatment of the same but its not the end game.The burden and damaging impact of post TB sequelae is also continuously rising especially in the case of Pulmonary tuberculosis. Post-TB lung disease(PTLD) has been overlooked as a significant cause of chronic lung disease. PTLD is defined as "Evidence of Chronic Respiratory Abnormality, with or without symptoms, attributable at least in part to previous pulmonary tuberculosis. It is a hetrogeneous condition which includes Airway,parenchyma, pleura and pulmonary vascular abnormalities. In this trial we are studying the patients who was diagnosed and treated for Drug Sensitive Pulmonary Tuberculosis as per NTEP guidelines at the completion of treatment (preferably within 2-4wks ). We are looking for any related clinical complaints or symptoms that persists or develops even after the completion of ATT such as Cough, Sputum, Wheeze, Chest pain, Haemoptysis and fatigue. We are also doing CECT chest to look for any structural abnormality of lung such as Bronchiectasis, Cavitation, fibrosis,pleural thickening and bronchiolitis. We are assessing them with Spirometry for FEV1/FVC ratio to look for any obstructive or restrictive pattern. Transthoracic echo is also planned to look for Pulmonary Arterial Hypertension. These Clinical, Radiological and Functional parameters will be evaluated at the end of study and the result will be published accordingly. |