FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091148 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Smoking Affects the Lungs After COVID-19 
Scientific Title of Study   Association Of Lung Parameters With Smoking Among Covid 19 Survivors. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shraddha Deshmukh 
Designation  Post graduate student  
Affiliation  SDM college of physiotherapy  
Address  OPD no 13, Department of Cardio respiratory disorders, SDM College of physiotherapy,Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India

Dharwad
KARNATAKA
580009
India 
Phone  9686095410  
Fax    
Email  shraddhadeshmukh801@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shraddha Deshmukh 
Designation  Post graduate student  
Affiliation  SDM college of physiotherapy  
Address  OPD no 13, Department of Cardio respiratory disorders, SDM College of physiotherapy,Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India

Dharwad
KARNATAKA
580009
India 
Phone  9686095410  
Fax    
Email  shraddhadeshmukh801@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubha Akadas 
Designation  Assistant professor and PG guide 
Affiliation  SDM college of physiotherapy 
Address  OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India

Dharwad
KARNATAKA
580009
India 
Phone  973948807  
Fax    
Email  shubha.akadas@sdmuniversity.edu.in  
 
Source of Monetary or Material Support  
SDM College Of Physiotherapy Manjushree Nagar, Sattur, Dharwad-580009, Karnataka, India. 
 
Primary Sponsor  
Name  Shraddha Deshmukh 
Address  SDM College Of Physiotherapy SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009 
Type of Sponsor  Other [Self] 
 
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 
Shraddha Deshmukh   Shri Dharmasthala Manjunatheshwara hospital  Cardiorespiratory Department OPD no 13 Manjushree Nagar Sattur Dharwad Karnataka Dharwad 580009 KARNATAKA
Dharwad
KARNATAKA 
9686095410

shraddhadeshmukh801@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SDM College Of Medical Sciences And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  COVID 19 survivors  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Individuals who have been tested positive for covid 19 and recovered over 1 yr.
2. All genders will be included.
3. Patient of age group between 18 to 50 years.
4. Smokers and non-smokers
5. Individuals with stable comorbidities like Hypertension, Diabetes mellitus, chronic kidney disease with precaution and on medication.
6. Individuals who are willing to participate in the study.
7. Individuals who can communicate. 
 
ExclusionCriteria 
Details  1. Individual with pre-existing severe lung condition (eg- COPD, asthma).
2. Individuals with existing neurological conditions.
3. Uncooperative/individuals who do not give their consent.
4. Individuals with locomotive disorders.
5. Individuals who have had recent thoracic, cardiac or abdominal surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Smokers who have had COVID-19: FEV1/FVC ratio may be significantly reduced and may indicate obstructive lung disease  After Screening The Inclusion And exclusion Criteria. 
 
Secondary Outcome  
Outcome  TimePoints 
Peak expiratory flow rate   After Screening The Inclusion And Exclusion Criteria 
 
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)   12/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/09/2025 
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 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  

This study investigates the long-term effects of COVID-19 on lung function and Peak Expiratory Flow Rate (PEFR) in smokers versus non-smokers. COVID-19, known to affect the respiratory system severely, has led to persistent pulmonary complications, including fibrosis and reduced lung function. Smokers are already at increased risk due to pre-existing lung damage, making it essential to understand their post-COVID recovery. The study aims to assess and compare lung function using spirometry (FEV1, FVC) and PEFR in individuals aged 18–50 who recovered from COVID-19 at least one year ago. By comparing smokers and non-smokers, it will help identify whether smoking exacerbates long-term pulmonary impairment after COVID-19. The study uses a cross-sectional observational design with a sample size of 100, applying simple random sampling. It aims to provide evidence to support smoking cessation and tailored pulmonary rehabilitation strategies. The novelty lies in its focus on long-term post-COVID lung changes in a healthy, working-age population—an area not well studied. Findings are expected to benefit clinical practice, guide public health interventions, and inform patient education by emphasizing the importance of smoking cessation in improving lung recovery and reducing the risk of long COVID-related respiratory dysfunction.


 
Close