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CTRI Number  CTRI/2025/04/084182 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Interstitial Lung Disease Among Patients at AVBRH: A Hospital-Based Study. 
Scientific Title of Study   Clinical Profile of Interstitial Lung Disease in the Patients Admitted to Acharya Vinoba Bhave Rural Hospital 
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 Poonam Avinash Patil 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College Datta Meghe Institute Of Higher Education And Research 
Address  Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research, Wardha, Maharashtra 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9987109358  
Fax    
Email  poonampatil268@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ulhas Jadhav 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College Datta Meghe Institute Of Higher Education And Research 
Address  Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research, Wardha, Maharashtra 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9970819099  
Fax    
Email  dr.ulhasjadhav@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR ULHAS JADHAV 
Designation  PROFESSOR 
Affiliation  JAWAHARLAL NEHRU MEDICAL COLLEGE 
Address  ACHARYA VINOBA BHAVE RURAL HOSPITAL, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, WARDHA, MAHARASHTRA 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9970819099  
Fax    
Email  dr.ulhasjadhav@gmail.com  
 
Source of Monetary or Material Support  
AVBRH AND JNMC, SAWANGI MEGHE WARDHA 
 
Primary Sponsor  
Name  Dr Poonam Patil 
Address  Acharya Vinoba Bhave Rural Medical College And Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha. 
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 
Dr Poonam Patil  Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College   Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA 		 9987109358

poonampatil268@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J849||Interstitial pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -Newly diagnosed case of interstitial lung disease
-patient with hrct thorax findings of ild
-patients with cough more than 3 months
-patients with dyspnoea more than 3 months
-patient having any multisystemic involvement
-patient age more than 18 years  
 
ExclusionCriteria 
Details  -Not willing to give consent
-non-complaint patients 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the clinical profile of interstitial lung disease  On the day of admission 
 
Secondary Outcome  
Outcome  TimePoints 
To study etiological & clinical profile of ILD & to examine the clinical characteristics, diagnostic approaches for patients of ILD  On the day of admission 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/05/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) -  for thesis and research purpose

  5. By what mechanism will data be made available?
    Response (Others) -  thesis

  6. For how long will this data be available start date provided 04-01-2025 and end date provided 04-01-2026?
    Response (Others) -  data will be available from thesis completion with no end date

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   THE THESIS AIMS TO STUDY THE CLINICAL PROFILE OF PATIENTS WITH INTERSTITIAL LUNG DISEASE ADMITTED TO AVBRH. IT FOCUSES ON IDENTIFYING THE ETIOLOGICAL AND CLINICAL PROFILE OF INTERSTITIAL LUNG DISEASE, EXAMINING THE CLINICAL CHARACTERISTICS, DIAGNOSTIC APPROACHES AND EVALUATING THE ASSOCIATIONS BETWEEN PREDISPOSING FACTORS AND SPECIFIC INTERSTITAL LUNG DISEASES SUB TYPES. 
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