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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 00:09:43 GMT) CTRI Number CTRI/2021/01/030242 [Registered on: 05/01/2021] - Trial Registered Prospectively Last Modified On 04/01/2021 Post Graduate Thesis Yes Type of Trial Observational Type of Study Cross Sectional Study Study Design Other Public Title of Study Covid 19 among healthcare professionals Scientific Title of Multifactorial analysis of COVID 19 infection among healthcare professionals Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Bhalendu Vaishnav Trial Coordinator (multi-center study) Designation Professor and Head Affiliation Pramukhswami Medical College, Karamsad Address Department of Medicine, Pramukhswami Medical College, Shree Krishna Hospital, Karamsad Anand GUJARAT 388325 India Phone 02692228171 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Bhalendu Vaishnav Query) Designation Professor and Head Affiliation Pramukhswami Medical College, Karamsad Address Department of Medicine, Pramukhswami Medical College, Shree Krishna Hospital, Karamsad Anand GUJARAT 388325 India Phone 02692228171 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr BhoomiKUmar Patel Designation First year postgraduate student Affiliation Pramukhswami Medical College, Karamsad Address Department of Medicine, Pramukhswami Medical College, Shree Krishna Hospital, Karamsad Anand GUJARAT 388325 India Phone 02692228171 page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Pramukhswami Medical College, Karamsad. Primary Sponsor Primary Sponsor Details Name Instituton Pramukhswami Medical College Karamsad Address Department of Medicine,Pramukhswami Medical College, Karamsad Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Bhalendu Vaishnav COVID Isolation Pramukhswami Medical 02692228171 ward,Shree Krishna College and Shree Hospital Krishna Hospital, bhalendusv@charutarh Karamsad ealth.org Anand GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 03/12/2020 No ETHICS COMMITTEE - 2 H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION, KARAMSAD Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Patients Unspecified acute lower respiratory infection Intervention / Type Name Details Comparator Agent Comparator Agent NIL Not Applicable Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) Gender Both Details Inclusion: All healthcare professionals admitted at Shree Krishna Hospital who have had suffered from COVID 19 (RT-PCR positive) during the period of 1st March 2020 to 31st December, 2020. Exclusion Criteria Exclusion Criteria Details Exclusion criteria: All healthcare professionals who have taken treatment on outdoor basis. Method of Generating Not Applicable Random Sequence Method of Not Applicable page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Clinical profile of COVID among healthcare at baseline, during course of illness, at the time professionals of discharge from the hospital Secondary Outcome Outcome Timepoints Response to therapy and Post traumatic stress At least after 3 weeks post discharge disorder among healthcare professionals afflicted with COVID 19 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 11/01/2021 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 Not Yet Recruiting Trial (India) Publication Details NIl Brief Summary Affliction of healthcare professionals by COVID 19 is a major professional hazard. There is dearth of multifactorial analysis of possible circumstances leading to their affliction, clinical and laboratory spectrum of illness and its outcome in this subset of patients. There are limited studies on psychological wellbeing of healthcare professionals who have become COVID patients, particularly post-traumatic stress disorder. Protecting healthcare professionals is paramount in successful management and containment of an infectious outbreak. The COVID-19 pandemic has highlighted the critical need to focus on its impact on the mental health of Healthcare Workers (HCWs) involved in the response to this emergency. It has been consistently shown that a high proportion of healthcare professionals are at greater risk for developing PosttraumaticStress Disorder (PTSD) and Posttraumatic Stress Symptoms (PTSS). Objectives of the present study: - To discern clinical, biochemical and radiological profile of healthcare professionals suffering from COVID 19 at Shree Krishna Hospital - To evaluate post-Covid psychological health in form of Post-traumatic stress disorder symptoms as will be measured by Impact of Events Scalerevised (IES-R). Retrospective and prospective analysis of epidemiologic, clinical, biochemical and radiological profile of participants will be carried out. This study will help to analyze multiple aspects of COVID in healthcare professionals in our institution, viz. epidemiologic, health educational, clinical profile, outcome and psychological. page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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