| CTRI Number |
CTRI/2025/05/086470 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
OBSTRUCTIVE AIRWAY DISEASE IN CURED CASES OF PULMONARY TUBERCULOSIS |
|
Scientific Title of Study
|
OBSTRUCTIVE AIRWAY DISEASE IN PREVIOUSLY CURED CASES OF PULMONARY TUBERCULOSIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aswathy L R |
| Designation |
Resident Doctor |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
Department of respiratory medicine
Sir T Hospital
Jail Road
Kalanala
Devbagh 364002
Department of respiratory medicine
Sir T Hospital
Jail Road
Kalanala
Devbagh 364002
Bhavnagar
GUJARAT
364002
India |
| Phone |
9961777990 |
| Fax |
|
| Email |
aswathylr7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jigna Trivedi |
| Designation |
Professor and HOD |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
Sir T Hospital and Government Medical College
Jail Road
Kalanala
Devbagh 364002
Sir T Hospital and Government Medical College
Jail Road
Kalanala
Devbagh 364002
Bhavnagar
GUJARAT
364002
India |
| Phone |
9825096289 |
| Fax |
|
| Email |
drjignadave@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathy L R |
| Designation |
Resident Doctor |
| Affiliation |
Goverment Medical College, Bhavnagar |
| Address |
Department of respiratory medicine
Sir T Hospital
Jail Road
Kalanala
Devbagh 364002
Department of respiratory medicine
Sir T Hospital
Jail Road
Kalanala
Devbagh 364002
Bhavnagar
GUJARAT
364002
India |
| Phone |
9961777990 |
| Fax |
|
| Email |
aswathylr7@gmail.com |
|
|
Source of Monetary or Material Support
|
| RESPIRATORY MEDICINE DEPARTMENT,SIR T HOSPITAL AND GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
|
|
Primary Sponsor
|
| Name |
Dr Aswathy LR |
| Address |
Department of Respiratory Medicine , sir t hospital ,Bhavnagar |
| 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 Aswathy L R |
Government Medical College Bhavnagar |
PFT Room Department of Respiratory Medicine , Government Medical College Bhavnagar
Bhavnagar
Gujarat
Bhavnagar
GUJARAT |
9961777990
aswathylr7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goverment Medical college, Bhavnagar |
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 |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1Age group 18 to 60 years.
2Patients with symptoms of dyspnea or cough with or without expectoration greater than or equal to 2 weeks.
3Previously cured(atleast before 2 years) cases of pulmonary tuberculosis.
4Sputum smear AFB negative patients.
|
|
| ExclusionCriteria |
| Details |
Past history of respiratory illness before taking AKT.
Absolute and relative contraindication of PFT
1Chronic renal failure
2Psychiatric illness
3Malignancy
4Pregnant and lactating females
5HIV Positive patients Â
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETECT OBSTRUCTIVE AIRWAY DISEASE IN POST TUBERCULOSIS PATIENTS |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare fev1/fvc ratio between smokers & non smokers.
To assess the severity of obstructive airway disease among smokers.
To assess of severity of obstructive airway disease with pattern of X ray chest
To determine association of smoking index with severity of obstructive airway disease |
BASELINE BY DOING PFT |
|
|
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)
|
20/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
step 1- Prior permission will be taken from Ethical committee , Government Medical College, Bhavnagar. step2- Participants who come to respiratory medicine department during the study period meeting inclusion and exclusion criteria and who are willing to give written informed consent will be taken in study. step3- Data regarding smoking, age, gender, co-morbidities, past history of AKT will be collected. step 4 -Before the test Height ,Weight ,Age , Sex will be recorded step5- Pulmonary function test will be done in enrolled participant with computerized spirometer. soft clips will be put on nose. The nose clips ensure that person breathe through mouth, not nose. Patient has to put his or her lips around a mouthpiece, and the mouthpiece connects to a spirometer Ask patient to take deep breaths in and blow out as hard as possible .
step 6-Data of FEV1,FVC, FEV1/FVC will be taken. step7-Statistical analysis will be done with appropriate software.
|