| 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
|
|
|
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
|
|
|
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. |