| CTRI Number |
CTRI/2026/02/103105 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Symptomatology and radiological profile of post Tuberculosis patients |
|
Scientific Title of Study
|
Clinico-radiological profile of post Tuberculosis obstructive airway disease patients: A multicentre prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arjun Khanna |
| Designation |
Asst Professor |
| Affiliation |
Amrita Hospital, Faridabad |
| Address |
Room number 3207, Department of pulmonary Med. Amrita Hospital, Sector 88, Faridabad
HARYANA
121002
India
Faridabad
HARYANA
121002
India |
| Phone |
8745008580 |
| Fax |
|
| Email |
doc.khanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Bajad |
| Designation |
Asst Professor |
| Affiliation |
Amrita Hospital, Faridabad |
| Address |
Room number 3205, Department of pulmonary Med. Amrita Hospital, Sector 88, Faridabad
HARYANA
121002
India
Faridabad
HARYANA
121002
India |
| Phone |
9468568815 |
| Fax |
|
| Email |
pradeepbajad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Bajad |
| Designation |
Asst Professor |
| Affiliation |
Amrita Hospital, Faridabad |
| Address |
Room number 3205, Department of pulmonary Med. Amrita Hospital, Sector 88, Faridabad
HARYANA
121002
India
Faridabad
HARYANA
121002
India |
| Phone |
9468568815 |
| Fax |
|
| Email |
pradeepbajad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multi-centre study including Amrita hopsital faridabad, Amrita hospital Kochi, Maulana Azad medical college Delhi, Himalayan Institute Dehradun, King George Hospital Lucknow, Baba Saheb Ambedkar Hospital Delhi |
|
|
Primary Sponsor
|
| Name |
Amrita Hospital Faridabad |
| Address |
Sector 88 Faridabad Haryana 121002 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Gupta |
Ambedkar Medical College, Delhi |
Sector-6, Rohini, New Delhi - 110085.
New Delhi
DELHI |
9811671089
docshweta24@gmail.com |
| Dr Pradeep Bajad |
Amrita Hospital |
Amrita Hospital, Sector 88, Faridabad
Faridabad
HARYANA
121002
India
Faridabad
HARYANA |
9468568815
pradeepbajad@gmail.com |
| Dr Akhilesh K |
Amrita Hospital, Kochi |
Ponekkara, Kochi
Ernakulam
KERALA |
8547258738
akhileshkunoor@gmail.com |
| Dr Rakhee Khanduri |
Himalayan Institute of Medical Science |
Swani Ram Nagar, Doiwala, 248016
Dehradun
UTTARANCHAL |
911352471362
rakheekhanduri@srhu.edu.in |
| Dr Jyoti Bajpai |
King George Medical College |
Shahmina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH |
9871755108
jyotibajpai33@gmail.com |
| Dr Shipra Anand |
Maulana Azad Medical College |
2- Bahadur shah Zafar Marg
New Delhi
DELHI |
9871755108
shipra_anand_lall@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Amrita Vishwa Vidyapeetham institute of medical science |
Approved |
| Baba Saheb Ambedkar Medical college |
Approved |
| Himalayan Institute |
Approved |
| King George Medical College |
Approved |
| Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients with active obstructive airway disease symptoms who had microbiologically or clinic radiologically proven and treated pulmonary tuberculosis and exhibiting post bronchodilator spirometry results showing FEV1 FVC less than 70% or less than lower limit for age. Patient above 18 years of age. |
|
| ExclusionCriteria |
| Details |
Active Tuberculosis
Asthma or COPD
Smoking history with more 10 pack years
Bronchiectasis due to nontubercular causes
Cardiac insufficiency
Interstitial lung disease
Connective tissue disease
Pulmonary fibrosis
History of thoracic surgery
Patients, who are unable to complete all the investigations
Patients not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study clinical profile of Post TB obstructive diseases and its
correlation with thorax radiology and pulmonary function tests
2. To study and identify various obstructive disease pattern e.g.,
Bronchiectasis, small airway disease, asthma like obstructive airway disease, airway stenosis. |
1. To study clinical profile of Post TB obstructive diseases and its
correlation with thorax radiology and pulmonary function tests
2. To study and identify various obstructive disease pattern e.g.,
Bronchiectasis, small airway disease, asthma like obstructive airway disease, airway stenosis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of Post TB obstructive diseases severity with severity of tuberculosis episode, patient age during
tuberculosis episode. |
Single Point of time, during enrolment |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
03/10/2026 |
| 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
|
Tuberculosis (TB) remains a major global health problem, and a significant proportion of patients develop long-term pulmonary sequelae even after successful treatment, collectively termed post-tuberculosis lung disease (PTLD). PTLD contributes substantially to the global burden of chronic lung disease and encompasses a spectrum of abnormalities involving large and small airways (including bronchiectasis and obstructive lung disease), lung parenchyma, pulmonary vasculature, and pleura. Pulmonary TB has been strongly associated with the development of chronic airflow obstruction, which is objectively defined using post-bronchodilator spirometry, the gold standard diagnostic tool. Airflow obstruction may develop during active TB or after treatment, likely due to TB-related structural damage, particularly involving the small airways, along with shared risk factors. However, the underlying mechanisms, natural history, and treatment response of post-TB airway disease remain poorly understood. Despite the high prevalence of TB-associated obstructive pulmonary disease (TOPD) in India, there is limited guidance on its diagnosis and management. Generating region-specific data on clinical presentation and pulmonary function abnormalities is essential to improve understanding of disease behavior and guide optimal management strategies. |