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Clinical Trial Details (PDF Generation Date :- Sun, 03 Oct 2021 02:07:07 GMT) PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sun, 03 Oct 2021 02:07:07 GMT) CTRI Number CTRI/2020/08/027168 [Registered on: 14/08/2020] - Trial Registered Prospectively Last Modified On 28/08/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Probiotic Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study Clinical trial study to investigate safety and efficacy of ImmunoSEB and ProbioSEB Scientific Title of A randomized, open label, 2 Arm, prospective study to investigate the safety and efficacy of the Study health supplements ImmunoSEB+ProbioSEB CSC3 as supplemental therapy in confirmed mild to moderate COVID-19 patients. Secondary IDs if Any Secondary ID Identifier PROCLIN_COVID-005 ver.1.0 date 09 July 2020 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Abhay Vispute Shantaram Trial Coordinator (multi-center study) Designation Investigator Affiliation SRV Hospital Address SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra Mumbai MAHARASHTRA 400089 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Abhay Vispute Shantaram Query) Designation Investigator Affiliation SRV Hospital Address SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra Mumbai MAHARASHTRA 400089 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Abhay Vispute Shantaram Designation Investigator Affiliation SRV Hospital Address SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Mumbai MAHARASHTRA 400089 India Phone Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra 400089 Primary Sponsor Primary Sponsor Details Name SRV Hospital Address Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra 400089 Type of Sponsor Private hospital/clinic Details of Secondary Name Address Sponsor SRV Hospital Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra 400089 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Abhay Vispute SRV Hospital Dr Mandakini Parihar 9223247247 Shantaram Marg opposite Lokmanya Tilak drasv.surgiciansrv@gm Terminus, Tilak Nagar, ail.com Chembur, Mumbai, Maharashtra 400089 Mumbai MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? New Health Care Approved 10/08/2020 No Nursing Home , New Health Care Nursing Home C Satellite Park Near G.C.C Club Mira Road (E) Thane Thane Maharashtra - 401107 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 ImmunoSEB plus ProbioSEB ImmunoSEB Capsule / 500 mg CSC3 2 capsule bid and ProbioSEB CSC3 Capsule / 5 billion CFUs 2 Capsule OD for 14 days Comparator Agent Standard Care standard care given as per institutional practice page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details 1.Patient who provides written informed consent<br/> 2.Male or non-pregnant, non-lactating female aged ? 18 and ? 75 years (both inclusive)<br/> 3.RT-PCR confirmed diagnosis of COVID-19<br/> 4.Able to take the drug orally and comply with study procedures<br/> 5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry<br/> <br/> Exclusion Criteria Exclusion Criteria Details 1. Severe Type Respiratory distress, RR?30 times/min Finger oxygen saturation ?93% in rest state Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation FiO2 ?300mmHg 2. Critical type: meeting any of the following criteria Respiratory failure occurs and mechanical ventilation is required Patients go into shock ICU is needed for other organ failure. 3.Patients who have received tumor immunotherapy such as PD-1/L1 CTLA4 etc. in the past 1 month, and inflammatory factor modulators such as Ulinastatin. 4.other viral pneumonia 5.patients who have received tumor immunotherapy in tha past one month and inflammatory factor modulators such as Ulinastatin 6. patients who have received organ transplantation or surgery planning in the past 6 months 7. patients who cant take food or drugs due to coma or intestinal obstruction 8.Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc 9.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period 10.Allergic to systemic enzyme supplements 11.Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or patients with child-Pugh grade C cirrhosis 12.ECLS (ECMO, ECCO2R, RRT) 13.Imminent death in the opinion of the clinical team 14.Patients who have participated in any other clinical study within 2 weeks prior to randomization 15.15. The investigator concludes that the patient is not suitable for the study Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Proportion of patients showing clinical Proportion of patients showing clinical improvement improvement time frame day 14 from the baseline visit page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Secondary Outcome Outcome Timepoints 1. Proportion of patients showing clinical 1. Day 7 improvement [Time Frame: Day 7] 2.day 21 2. Proportion of patients showing clinical 3. upto day 21 improvement [Time Frame: Day 21] 3. Time (Days) to clinical improvement [Time Frame: upto 21 days] 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 21/08/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=2 Days=10 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details NIL Brief Summary To evaluate the effect on the primary endpoint of the experimental regimen through pairwise comparisons of the experimental regimen ImmunoSEB + ProbioSEB CSC3 with a standard-of-care control arm, and under a sequential design. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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