| CTRI Number |
CTRI/2023/08/056174 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
03/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Thyroid function and Chemical markers in Lung Disease |
|
Scientific Title of Study
|
A Study Of Thyroid Function Test and Inflammatory Markers In COPD Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abid Ahmed c |
| Designation |
Junior Resident ( PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical college
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9072005753 |
| Fax |
|
| Email |
abidmarcelo97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dayaram Haldwani |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology
Maulana Azad Medical college
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9810622392 |
| Fax |
|
| Email |
drhaldwani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dayaram Haldwani |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Department of Physiology
Maulana Azad Medical college
Bahadur shah zafar marg
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9810622392 |
| Fax |
|
| Email |
drhaldwani@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
New Delhi. |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
Maulana Azad medical college
Bahadur shah zafar marg
New Delhi - 110002 |
| Type of Sponsor |
Government 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 Abid ahmed c |
Maulana Azad medical college |
Department of Physiology,
Maulana Azad medical college
Bahadur shah zafar marg
New delhi - 110002
Central
DELHI |
9072005753
abidmarcelo97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, 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 |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Stable COPD patients (no exacerbations due to any reason in the last 4 weeks) diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease(GOLD) guidelines. |
|
| ExclusionCriteria |
| Details |
1. Patients with a respiratory disorder other than COPD (Active Pulmonory Tuberculosis, Bronchiectasis, Cystic fibrosis, Asthma, Interstitial Lung Disease, Lung Cancer, a history of Pulmonory Bulla, Pneumonectomy or Other Lung Surgery.)
2.Patients with pre-existing thyroid illness,on anticoagulant therapy ,on immunosuppressive drugs, no neuropsychological illness , cancer , severe renal or hepatic diseases,uncontrolled Hypertension, CCF , History of MI in last 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The proportion of thyroid dysfunction in stable COPD patients.
2. The proportion of deranged inflammatory markers in stable COPD patients.
3. The BODE Index score & Quartile of every study subject.
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The association between inflammatory markers & thyroid function status in stable COPD patients.
|
Baseline |
The association between BODE Index score & Quartiles & thyroid function status, as well as inflammatory markers in stable COPD patients.
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/08/2023 |
| 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
|
This project is being done with the aim of studying Thyroid funaction status and Inflammatory level markers in stable COPD patients. The study will be conducted in MAMC and Associated LNJP Hospital New delhi. |