| CTRI Number |
CTRI/2024/11/076712 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The relation between Connective Tissue Diseases and Lung Diseases |
|
Scientific Title of Study
|
Study of clinical profile and severity in connective tissue disease-interstitial lung disease(CTD-ILD) |
| 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 I Sri Hanuman |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Kasturba hospital, Madhav Nagar Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7013392150 |
| Fax |
|
| Email |
srihanumainturi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAM BHAT |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Head Of Unit, Department of General Medicine, Kasturba Medical College, Kasturba hospital, Madhav Nagar Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Sri Hanuman |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Kasturba hospital, Madhav Nagar Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
7013392150 |
| Fax |
|
| Email |
srihanumainturi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine
Kasturba Medical College , Madhav Nagar, Manipal
pin-576104 |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine |
| Address |
Opd no- 17, Kasturba Medical College , Madhav Nagar, Manipal pin-576104 |
| 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 I Sri Hanuman |
Kasturba Hospital, Manipal |
Room No-17 ,Department of General Medicine, Kasturba hospital, Madhav Nagar, Manipal.Pin-576104
Udupi
KARNATAKA |
7013392150
srihanumainturi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe-Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1. Patients who have a confirmed diagnosis of interstitial lung disease(ILD) associated with a known(CTD)
connective tissue disease (e.g. rheumatoid arthritis, systemic sclerosis, dermatomyositis etc.).
2. Clinical Parameters: Individuals displaying relevant clinical symptoms such as cough, dyspnea (shortness of
breath), fatigue, and evidence of lung involvement on imaging studies.
3. Confirmed Connective Tissue Disease: Patients diagnosed with a connective tissue disease with supportive
evidence of Antibodies.
5. Patients Age ABOVE 18 years
6. diagnosed with any of
the below mentioned connective tissue disorders:
1. Systemic Sclerosis
2. Systemic Lupus Erythematosus/SLE
3. Mixed Connective Tissue Disease (MCTD)
4. Rheumatoid Arthritis/RA
5. Inflammatory myositis- Dermatomyositis/Polymyositis
6. Sjogren’s disease
7. Undifferentiated Connective Tissue Disease (UCTD)
|
|
| ExclusionCriteria |
| Details |
1. Other Lung Diseases: Exclude individuals with lung diseases not associated with connective tissue disorders,
such as chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis unrelated to CTDs.
2. Drug-induced lung disease(like methotrexate induced)
3. Malignancy
4.Pregnant females
5. Active infections and comorbidities including congestive heart failure, renal and liver failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study the pattern of involvement of lung in various CTD-ILD (Connective Tissue Disease- related Interstitial Lung Disease)and IPAF (Interstitial pneumonia with autoimmune features)
and to correlate the CTD(Connective Tissue Disease) pattern of ILD (Interstitial Lung Disease) with AUTOIMMUNE PROFILE |
From the date of admission to date of discharge, and also follow-up during opd visits |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess the severity of the CTD-ILD (Connective Tissue- Interstitial Lung Disease) with the various markers including DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide )/ RDW (red cell distribution width)/ CRP (C-Reactive Protein ) /NLR (neutrophil/lymphocyte ratio)
To correlate CT pulmonary grading with DCLO (Diffusing Capacity of the Lungs for Carbon Monoxide )/PFT (Pulmonary Function Test) |
From the date of admission to date of discharge, and also follow-up during opd visits |
|
|
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)
|
20/11/2024 |
| 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="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
|
After Obtaining Due Permission and Clearance From the Departments Involved (Ethics Committee), the Patients Meeting the Inclusion Criteria, After Ruling Out the Exclusion Criteria Will Be Recruited into the Study After Obtaining Their Informed Consent. The Clinical and Laboratory Data, Including Presenting Complaints, Relevant Examination Findings, Blood Investigation Reports Involving Autoimmune Workup (Ana Global, Ana Profile), Rdw(Red cell distribution width), Neutrophil-Lymphocyte Ratio (NLR) Along With Hrct, ( PFT)Pulmonary Function Test, Dlco (Diffusing Capacity of the Lungs for Carbon Monoxide) Findings, and Additional Imaging Findings as Applicable, Will Be Tabulated in a Pre-designed Proforma. The Findings of Imaging- Xray and HRCT done as a Standard of Routine Care Are Noted to Look for Diagnosis and Severity. In Case a Recruited Participant Has Multiple Visits During the Study Period, Relevant. Additional Details Like Disease Progression and New Findings in Blood Investigations, HRCT, or Imaging Will Be Noted
|