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CTRI Number  CTRI/2024/06/068234 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 01/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the biological molecules called biomarkers of inflammation raised in blood in patients of chronic obstructive pulmonary disease who are above 40 years and how they are connected to co-morbid conditions in same patients. 
Scientific Title of Study   Study of inflammatory biomarkers in COPD and their association with co-morbidities 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aishwarya Kedar 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research,Sawangi Meghe,Wardha,Maharashtra,442001,India 
Address  Respiratory Medicine department,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha Maharashtra 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  8600775696  
Fax    
Email  aishwaryakedar@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Ulhas Jadhav 
Designation  professor 
Affiliation  Jawaharlal Nehru Medical College,Sawangi Meghe Wardha 
Address  Respiratory Medicine department,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha Maharashtra 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9284196369  
Fax    
Email  drulhasjadhav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aishwarya Kishor Kedar 
Designation  resident 
Affiliation  Jawaharlal Nehru Medical College,Sawangi Meghe Wardha 
Address  Respiratory Medicine department,Jawaharlal Nehru Medical College,Sawangi Meghe ,Wardha Maharashtra 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  8600775696  
Fax    
Email  aishwaryakedar@yahoo.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Wardha India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Sawangi Meghe,Wardha,Maharashtra,India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya Kedar  Datta Meghe Institute of Higher Education and Research  Dept of Respiratory Medicine, Ground Floor, AVBRH building, Sawangi Meghe ,Wardha,Maharashtra,India 442001
Wardha
MAHARASHTRA 
08600775696

aishwaryakedar@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Datta Meghe Institute of Higher Education and Research,Sawangi Meghe Wardha Maharashtra ,India 442001   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients who are diagnosed cases of COPD in the department of respiratory medicine at AVBRH and age above 40 years
 
 
ExclusionCriteria 
Details  Patients not willing to give consent and non cooperative patients.
Patients having any connective tissue disorder like rheumatoid arthritis.
Patients having COPD asthma overlap.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to determine the levels of inflammatory biomarkers in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Specifically, the focus is on measuring the levels of CRP (C-reactive protein), IL-6 (Interleukin-6), TNF-ALFA (Tumor Necrosis Factor Alpha), and fibrinogen in the blood samples of COPD patients. These biomarkers are chosen due to their established association with inflammation, and their levels may provide insights into the inflammatory processes occurring in COPD.
 
Assessment will be done every 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  N/A 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   23/07/2024 
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="2"
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  

Chronic Obstructive Pulmonary Disease (COPD) is a prevalent respiratory condition associated with systemic inflammation and various comorbidities, significantly impacting patients’ health outcomes. This study investigates the relationships between inflammatory biomarkers in COPD and their associations with comorbidities. By focusing on specific biomarkers such as C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-ALFA), and fibrinogen, we seek to unravel the complex interplay between systemic inflammation, COPD severity, and the prevalence of comorbidities. This research is critical for advancing our understanding of the systemic manifestations of COPD and informing targeted interventions for improved patient management.

Methods: This cross-sectional observational study will be conducted at AVBRH, a tertiary care hospital in central India, over two years . A sample size of 90 COPD patients will be randomly selected based on inclusion and exclusion criteria. Diagnostic tests will be performed, including pulmonary function tests, chest X-rays, and biomarker assessments. Statistical analyses, encompassing chi-square tests, Pearson’s correlation coefficient, and logistic regression, will explore associations between inflammatory biomarkers, COPD severity, and comorbidities. The study design ensures rigorous data collection and adherence to ethical standards, with SPSS 27.0 utilized for statistical analyses.

 
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