CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 13:55:07 GMT)

CTRI Number CTRI/2020/08/026985 [Registered on: 04/08/2020] - Trial Registered Prospectively Last Modified On 04/08/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Siddha Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Assessment of safety and efficacy of Kabasura Kudineer in mild to moderate COVID-19 Scientific Title of Assessment of safety and efficacy of Kabasura Kudineer as an add-on therapy in mild to moderate Study COVID-19. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Vivek Valliappan Trial Coordinator (multi-center study) Designation Tutor Affiliation Address Department of Pharmacology, Chettinad Hospital and Research Institute, Chettinad Health City, OMR, Kelambakkam, Chengalpattu district, Tamilnadu Chennai TAMIL NADU 603103 India Phone 9003103061 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ruckmani A Query) Designation Proffessor and Head Affiliation Chettinad Hospital and Research Institute Address Department of Pharmacology Chettinad Hospital and Research Institute Chettinad Health City Kelambakkam Chennai-603103 Chennai TAMIL NADU 603103 India Phone 9500102346 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Ruckmani A Designation Proffessor and Head Affiliation Chettinad Hospital and Research Institute Address Department of Pharmacology Chettinad Hospital and Research Institute Chettinad Health City Kelambakkam Chennai-603103 Chennai TAMIL NADU 603103 India

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Phone 9500102346 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Chettinad Hospital and Research Institute, Chettinad Health City, OMR, Kelambakkam, Chengalpattu District, Tamilnadu. Primary Sponsor Primary Sponsor Details Name Chettinad Hospital and Research Institute Address Chettinad Health City OMR Kelambakkam Pin 603103 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 Vivek V Chettinad Hospital and General medicine 9003103061 Reserach Institute OMR department, COVID-19 Kelambakkam ward, III Floor, A & B vivekvalliappan@gmail. Chengalpattu 603103 Block. com Kancheepuram TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Instituitional Human Approved 20/07/2020 No Ethics Committee, Chettinad Academy of Research and Education(CARE) 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 Intervention / Type Name Details Comparator Agent Intervention Kabasura Kudineer along with Kabasura kudineer 60ml twice standard treatment daily before food for 7 days along with standard treatment Comparator Agent Standard treatment as per the Standard treatment as per the hospital protocol hospital protocol Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) Gender Both Details a.COVID-19 positive patients with mild to moderate disease.
b.Males and females aged between 18 and 60 years who are admitted in Chettinad Hospital and Research Institute
c.Patients willing to give written informed consent.
Exclusion Criteria Exclusion Criteria Details a.Patients Suffering from Chronic diseases- hepatic, renal,

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Hypertension and Diabetes mellitus b.Pregnancy & lactation c. Severe COVID-19

Method of Generating Random Number Table Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Outcome Assessor Blinded Primary Outcome Outcome Timepoints 1.Time to Negative conversion of SARS CoV-2 4,7 days 2.Time to symptom resolution 3.Reduction in Viral load (0,4,7 days)

Secondary Outcome Outcome Timepoints 1. Progression to severe ARDS 7 days 2. Adverse effects/events Target Sample Size Total Sample Size=126 Sample Size from India=126 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 Phase 2 Date of First 14/08/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil There is no specific pharmacological agent effective in COVID-19 till date. All the drugs that are currently used are repurposed drugs which may or may not offer clinical improvement. Brief Summary Kabasura kudineer is a siddha preperation composed of 15 ingredients which is recommended by Ministry of AYUSH for the treatment of cough, sore throat, fever and respiratory

distress. Hence this preperation is taken up for evaluation of its effect in mild to moderate COVID-19 in comparison with the standard treatment in a tertiary care centre.

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