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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 23 Sep 2021 12:30:56 GMT) CTRI Number CTRI/2017/11/010636 [Registered on: 24/11/2017] - Trial Registered Prospectively Last Modified On 13/02/2021 Post Graduate Thesis No Type of Trial Observational Type of Study Cohort Study Study Design Other Public Title of Study Health services in Fish processing Industry Scientific Title of A model Occupational health initiative in a fish processing industry in Coastal Karnataka. Study Secondary IDs if Any Secondary ID Identifier Version 1.0 NIL Details of Principal Details of Principal Investigator Investigator or overall Name Muralidhar Kulkarni Trial Coordinator (multi-center study) Designation Associate Professor Affiliation Kasturba Medical College Address Department of Community Medicine Kasturba Medical College Manipal Manipal University Udupi KARNATAKA 576104 India Phone 9844810917 Fax 08202922275 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Muralidhar Kulkarni Query) Designation Associate Professor Affiliation Kasturba Medical College Address Department of Community Medicine Kasturba Medical College Manipal Manipal University Udupi KARNATAKA 576104 India Phone 9844810917 Fax 08202922275 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Muralidhar Kulkarni Designation Associate Professor Affiliation Kasturba Medical College Address Department of Community Medicine Kasturba Medical College Manipal Manipal University Udupi KARNATAKA 576104 India Phone 9844810917 page 1 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in Fax 08202922275 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > 1.Fish Industry, Pithrody, Udyavara, Udupi district and 2. Department of Community Medicine, Kasturba Medical College, Manipal, Udupi district Primary Sponsor Primary Sponsor Details Name Yashaswi Fish meal and oil company Address Pithrody Udyavara Type of Sponsor Other [Fish processing industry] Details of Secondary Name Address Sponsor Department of Community Medicine KMC Manipal Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Muralidhar Kulkarni Kasturba Hospital Department of 8202571201 Community Medicine, 8202922275 Kasturba Medical murali.kulkarni@manip College, Madhav Nagar al.edu Manipal Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 08/11/2016 No Committee Kasturba Hospital Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Healthy Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details All employees working in the fish processing industry will be examined in the study Exclusion Criteria Exclusion Criteria Details Employees not willing to participate in the study Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Number of important health hazards noticed in December 2017 the factory page 2 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in Number of important health hazards addressed Secondary Outcome Outcome Timepoints Number of employees examined November 2018 Target Sample Size Total Sample Size=300 Sample Size from India=300 Final Enrollment numbers achieved (Total)=300 Final Enrollment numbers achieved (India)=300 Phase of Trial N/A Date of First 25/01/2018 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Yet to be published Brief Summary The study has two components. The first component being formation of an inter-professional health team and assessing the health hazards in the fish processing industry. The second being health examination of the employees. page 3 / 3 Powered by TCPDF (www.tcpdf.org).
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