| CTRI Number |
CTRI/2025/09/094712 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
how silicosis affects day to day work and its effect on how you think, feel and act. |
|
Scientific Title of Study
|
Assessment of Quality of Life, Mental Health and Exercise Tolerance in Patients with Silicosis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanu Sharma |
| Designation |
2nd Year MBBS Student |
| Affiliation |
RUHS CMS |
| Address |
Academic Block, I Floor, RUHS-CMS, Kumbha Marg, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9358883153 |
| Fax |
|
| Email |
chenisharma662@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Sharma |
| Designation |
Professor |
| Affiliation |
RUHS CMS |
| Address |
2nd Floor, Biochemistry, RUHS-CMS, Kumbha Marg, Pratap Nagar, Jaipur
RAJASTHAN
302033
India |
| Phone |
9414314678 |
| Fax |
|
| Email |
sonalisharma14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanu Sharma |
| Designation |
2nd Year MBBS Student |
| Affiliation |
RUHS CMS |
| Address |
I floor, Academic Block, RUHS-CMS, Kumbha Marg, Pratap Nagar, Jaipur
RAJASTHAN
302033
India |
| Phone |
9358883153 |
| Fax |
|
| Email |
chenisharma662@gmail.com |
|
|
Source of Monetary or Material Support
|
| RUHS college of medical sciences , Sector 11 ,Kumbha marg, Pratap nagar , Jaipur -302033 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Tanu Sharma |
RUHS College of Medical Science |
1st floor , academic block ,Kumbha Marg, Sector-11, Pratap Nagar, Jaipur, Rajasthan, Pin Code:302033
Jaipur
RAJASTHAN |
9358883153
chenisharma662@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHSCMSETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J628||Pneumoconiosis due to other dust containing silica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients should of be more than 18 years age.
b.Confirmed diagnosis of silicosis based on spirometry and radiological findings.
c.Patients having history of occupational history of mining, construction and building, stone work, pottery, ceramics and glass making, sandblasting, foundry work or any other occupational history.
|
|
| ExclusionCriteria |
| Details |
a. Patients with history of an either unstable angina or myocardial infarction) within 30 days prior to the test.
b.Inability to perform 6MWT .
c.Patients who are at risk of acute respiratory failure, or the presence of a non-cardiopulmonary condition that may become exacerbated by exercise.
d.Patients with severe, uncontrolled hypertension and a resting heart rate greater than 120 bpm.
e.Any comorbidity which might affect exercise capacity
f.Patients with any kind of neuromuscular problems.
g.Patients on oxygen therapy.
h.Patients with acute T.B and lung tumors.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the quality of life in individuals with silicosis using the St. Georges Respiratory Questionnaire (SGRQ).
2. To evaluate the mental health status of silicosis patients using the Depression, Anxiety, and Stress Scale (DASS).
3. To measure the functional exercise capacity of individuals with silicosis using the 6-Minute Walk Test (6mWT).
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Mental Health Status of Silicosis Using the Depression, Anxiety, & Stress Scale |
at 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/10/2025 |
| 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="0"
Months="2"
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
|
Silicosis is a chronic lung disease, caused by inhaling respirable silica dust which can lead to a reduction in the lung function of the exposed workers and interferes with their activities of daily living. In 1999, the Indian Council of Medical Research reported that silicosis is a common occupational disease across India The effects of occupational silica exposure on the pulmonary function have been reported in many studies, however, health problems, such as respiratory impairments, may be associated with a worse quality of life, and there are few studies that consider it in silica exposed workers Very less studies have explored the effect of silica exposure, and lung function on the quality of life of the workers. This study will be hospital based cross- sectional observational study, in which the patients will be diagnosed with silicosis condition, their lung function tests will be done, subjects heart rate, blood pressure and oxygen levels will be assessed by asking them to walk on a 30-metre corridor for 6 minutes. Their quality of life and depression, anxiety and stress will be evaluated by appropriate scales and questionnaires. Results from this study can guide healthcare professionals in developing more comprehensive and tailored care plans for silicosis patients. |