| CTRI Number |
CTRI/2025/10/096321 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between years of exposure and peak expiratory flow rate in goldsmith workers of jalgaon city |
|
Scientific Title of Study
|
Correlation between years of exposure and peak expiratory flow rate in goldsmith workers of jalgaon city: A cross sectional study |
| 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 Amit Jaiswal |
| Designation |
Associate Professor |
| Affiliation |
DR Ulhas Patil College of Physiotherapy |
| Address |
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
9421570761 |
| Fax |
|
| Email |
physioamit194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAKSHI DHARMESH BARDIYA |
| Designation |
GRADUATE |
| Affiliation |
DR Ulhas Patil College of Physiotherapy |
| Address |
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
8459643644 |
| Fax |
|
| Email |
bardiyasakshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAKSHI DHARMESH BARDIYA |
| Designation |
GRADUATE |
| Affiliation |
DR Ulhas Patil College of Physiotherapy |
| Address |
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon
Jalgaon
MAHARASHTRA
425001
India |
| Phone |
8459643644 |
| Fax |
|
| Email |
bardiyasakshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ulhas Patil College of Physiotherapy,Jalgaon Kh 425001 |
|
|
Primary Sponsor
|
| Name |
Sakshi Bardiya |
| Address |
NH 06,Gat No.57 1, Khirdi Shivar,Tal And Dist Jalgaon,
425001 |
| 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 |
| Sakshi Bardiya |
Showrooms and factories of goldmaking |
Golani Market, Navi Peth, Jaikisan Wadi,Jalgaon
Jalgaon
MAHARASHTRA |
8459643644
bardiyasakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr. ulhas patil college of physiotherapy |
Approved |
| Institutional Ethical Committee of Dr. ulhas patil college of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Goldsmith workers of age 20-40 years with minimum 1 years of experience or more |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Goldsmiths workers with minimum of 1 years of experience or more.
2. Individuals of both genders, male and female are included.
3.Individuals who are interested in participating.
4. Age 20-40 years. |
|
| ExclusionCriteria |
| Details |
1. Individuals with addiction.
2.Individuals with known case of any musculoskeletal/neurological/cardiovascular/respiratory disease or disorder.
3.Individuals with known case of allergy to environmental pollutants.
4.Individuals who are engaged in any type of physical activity or pulmonary rehabilitation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peak Expiratory Flow Rate |
Immediate effect |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/11/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 aimed to investigate the correlation between years of occupational exposure and Peak expiratory flow rate in goldsmith workers of Jalgaon city. Objectives of this study are to assess the peak expiratory flow rate in goldsmith workers of Jalgaon city. and to find out the correlation between years of exposure and peak expiratory flow rate in goldsmith of Jalgaon city. Procedure- Ethical clearance will be taken from the Institutional Ethics Committee of Dr Ulhas Patil College of Physiotherapy, Jalgaon prior to the commencement of study. A Cross- Sectional study will be carried out at showrooms and factories of gold ornaments in Jalgaon city. Participants shall be selected based on the inclusion and exclusion criteria. First, the nature and purpose of study will be explained to the participants. A written consent will be taken from the participants. The participants will be informed about the procedure for the peak expiratory flow rate. The participants will be assessed for data collection and recording of the peak expiratory flow rate will be conducted. The data will be collected, analyzed and generated. Goldsmiths are frequently exposed to harmful chemicals and metal fumes during jewelry-making processes, which can negatively impact their respiratory health over time. A cross-sectional study will be conducted on 60 goldsmiths aged 20–40 years, using Peak expiratory flow meter to assess parameter PEFR . The study sought to identify whether prolonged exposure leads to changes in PEFR..The findings are expected to help in early detection of respiratory issues and promote preventive healthcare measures for this occupational group. |