| CTRI Number |
CTRI/2025/09/095075 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study using x-ray,MRI and Pulmonary function test values to evaluate types of Respiratory conditions in Farmers in Central India. |
|
Scientific Title of Study
|
Clinicoradiological Correlation of Respiratory Symptoms in Farmers in Central India A Cross Sectional Study in a Tertiary Hospital in Central India |
| 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. Radhieka Misra |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radiodiagnosis, Ground floor,AVBRH Building. Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
09450025533 |
| Fax |
|
| Email |
mradhieka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav V Mishra |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radiodiagnosis, Ground floor,AVBRH Building. Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9109053055 |
| Fax |
|
| Email |
drgvmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav V Mishra |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Radiodiagnosis, Ground floor,AVBRH Building. Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9109053055 |
| Fax |
|
| Email |
drgvmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal nehru medical college, Sawangi(Meghe), Wardha, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Jawaharlal nehru medical college, Sawangi(Meghe), Wardha, Maharashtra |
| Address |
Jawaharlal nehru medical college, Sawangi(Meghe), Wardha, Maharashtra
442001
India |
| Type of Sponsor |
Other [self] |
|
|
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 Radhieka Misra |
Acharya Vinobha Bhave Rural Hospital |
Department of Radiodiagnosis,Ground floor AVBRH building, Sawangi Meghe
Wardha
MAHARASHTRA |
9450025533
mradhieka@gmail.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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J670||Farmers lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All farmers with respiratory symptoms 18to75 years
Duration of exposure more than six months |
|
| ExclusionCriteria |
| Details |
History of active pulmonary tuberculosis or lung malignancy or thoracic surgery
Acute respiratory tract infections in the past four weeks
History of any autoimmune disorder
Contraindications to PFT or Chest x-ray or HRCT scanning
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinicoradiological correlation of respiratory
symptoms in farmers in Central India who have prolonged exposure to agricultural dusts and bioaerosols. |
Assessment will be done at 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe the radiographic patterns seen on Chest X-ray and HRCT among exposed farmers with respiratory symptoms and evaluate pulmonary function test (PFT) abnormalities and correlate them.
To evaluate the association between HRCT abnormalities and duration/intensity of exposure to farming-related dusts and moulds.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
01/10/2025 |
| 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="2"
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 study has significant public health and clinical implications.It highlights the importance of early radiological evaluation (especially HRCT) in detecting subtle lung changes in exposed individuals, even when chest X-rays or symptoms are non-specific. It will help in differentiating occupational lung diseases from common misdiagnoses like tuberculosis or asthma, which are prevalent in rural India.It provides information that can form the basis of occupational screening protocols in agricultural health policies.The study highlights the need for preventive measures, such as dust control practices and personal protective equipment (PPE) for farmers. |