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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 19:42:24 GMT) CTRI Number CTRI/2020/06/025874 [Registered on: 15/06/2020] - Trial Registered Prospectively Last Modified On 15/06/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Siddha Study Design Randomized, Parallel Group Trial Public Title of Study To observe the effect of Siddha formulation Kabasura kudineer in COVID 19 patients Scientific Title of A randomized open labeled clinical study to compare the effectiveness of Kabasura kudineer and Study Vitamin-C Zinc supplementation in the management of asymptomatic SARS-CoV-2 patients Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr P Sankararaj Trial Coordinator (multi-center study) Designation Assistant Medical Officer Siddha Affiliation Government Theni Medical College and Hospital Address Siddha wing Government Theni Medical College and Hospital Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 Theni TAMIL NADU 625531 India Phone 9965897075 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr P Sankararaj Query) Designation Assistant Medical Officer Siddha Affiliation Government Theni Medical College and Hospital Address Siddha wing Government Theni Medical College and Hospital Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 Theni TAMIL NADU 625531 India Phone 9965897075 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr C Anbarasi Designation Research Officer Siddha Affiliation Siddha Central Research Institute Address Arignar Anna Hospital Campus Arumbakkam Chennai Arignar Anna Hospital Campus Arumbakkam Chennai Chennai TAMIL NADU page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in 600106 India Phone 8754416050 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Government Theni Medical College, Kochi - Madurai - Dhanushkodi Rd, Theni Allinagaram, Tamil Nadu 625531 and Central Council for Research in Siddha,Arignar Anna Hospital Campus, Arumbakkam, Chennai Primary Sponsor Primary Sponsor Details Name Dean Government Theni Medical College Address Government Theni Medical College Kochi Madurai Dhanushkodi Road Theni Allinagaram Tamil Nadu 625531 Type of Sponsor Government medical college Details of Secondary Name Address Sponsor Director General Central Council for Research in Siddha Ministry of AYUSH Arumbakkam Chennai 600106 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr P Sankararaj Government Theni Kochi Madurai 9965897075 Medical College and Dhanushkodi Road Hospital Theni Allinagaram [email protected] Tamil Nadu 625531 m Theni TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Government Theni Approved 08/06/2020 No Medical College and Hospital 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 Siddha medicine 30 – 60 ml twice daily orally Comparator Agent Zinc and Vitamin C Zinc -100 mg, Vit C – 60000 IU twice daily orally Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1.Laboratory confirmed COVID-19 without symptoms<br/> 2.Consenting to participate in the study and sign the informed consent Exclusion Criteria Exclusion Criteria page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Details 1.Patient with co morbid conditions like DM, HT and BA. 2.Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID-19. 3.Pregnant and mothers those who have a pregnancy plan. 4.Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, etc., which the researchers consider unsuitable for participation in the study. 5.People who have been allergic to Siddha medicine or intolerant to taking medicine. 6.Patients participating in other COVID-19 clinical trials. Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints 1.Reduction in incidence of clinical symptoms 14 days like fever, cough and breathlessness. 2.Negative conversion of SARS-CoV-2 by 14 days 3.Reduction in Viral load of SARS-CoV-2 at the end of treatment (0, 7, 14 days) 4.Examine the levels of immune markers and inflammatory markers (IgG, IgM, IgA, Th1 (TNF-Alfa, IFN-gamma, IL2) Th2 (IL6, IL10) at the end of treatment (0, 7, 14 days) Secondary Outcome Outcome Timepoints 1.Reduction in incidence of complications. 14 days 2.Reduction of in hospital time. 3.Laboratory markers 4.Adverse events/effects 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 Phase 2 Date of First 24/06/2020 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 Brief Summary Siddha system of medicine has contributed in lowering health burden during public health emergency. It is proposed to have a good potential to combat COVID-19. One of the classical Siddha formulations is page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Kabasurakudineer (KSK) consists of 15 herbal ingredients. This study is proposed to observe the effect of Kabasura kudineer compared with Viamin C and Zinc supplements in asymptomatic patients with SARS CoV- 2 infection. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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