PDF of Trial CTRI Website URL

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 05:01:17 GMT)

CTRI Number CTRI/2020/06/025852 [Registered on: 12/06/2020] - Trial Registered Prospectively Last Modified On 12/06/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Ayurveda Study Design Single Arm Trial Public Title of Study RNB in UPUMS SAIFAI Scientific Title of STUDY TO EVALUATE EFFECT OF RNB (RAJ NIRVAN BATI) AYURVEDIC MEDICINE IN Study COVID-19 ILLNESS Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Raj Kumar Trial Coordinator (multi-center study) Designation vice chancellor Affiliation Department of Neurosurgery Address Office of Vice Chancellor administrative Block up university of medical sciences saifai, etawah UP University of Medical Sciences saifai, etawah Etawah UTTAR PRADESH 206130 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Raj Kumar Query) Designation vice chancellor Affiliation Department of Neurosurgery Address Administrative block up university of medical sciences saifai, etawah UP University of medical sciences saifai, etawah (UP) Etawah UTTAR PRADESH 206130 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Raj Kumar Designation vice chancellor Affiliation Department of Neurosurgery Address Administrative block up university of medical sciences saifai, etawah (UP) up university of medical sciences saifai, etawah (UP) Etawah UTTAR PRADESH 206130 India

page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in

Phone Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > UP UNIVERSITY OF MEDICAL SCIENCES, SAIFAI, ETAWAH Primary Sponsor Primary Sponsor Details Name INTRA MURAL Address UP UNIVERSITY OF MEDICAL SCIENCES Type of Sponsor Government 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 RAJ KUMAR COVID HOSAPITAL UP UNIVERSITY OF 7830516316 MEDICAL SCIENCES SAIFAI ramakant.gsvm@gmail. Etawah com UTTAR PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? IEC, UPUMS Approved 27/05/2020 No 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 AYURVEDIC DRUG RNB DAIL DOSE OF RNB(125mg)BD IS GIVEN TO COVID 19 POSITIVE PATIENTS WHO FULL FILL TH E INCLUSION AND EXCLUSION CRITERIA for 10 days Comparator Agent NOT APPLICABLE NOT APPLICABLE Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details 1.Age?18years
2.Laboratory(RT-PCR)positiveofSARS- CoV-2
Exclusion Criteria Exclusion Criteria Details 1.Patient refuse for consent. 2.Criticalyil patient (Sp021.5mg/dl) 4.Pregnancy&lactating.

Method of Generating Not Applicable

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Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints 1)Clinical improvement of symptoms which was after 10 day of intervetion their at the time of admission 2)microbiological: microbiological clearance of virus by nasal swab and throat swab by RTPCR Secondary Outcome Outcome Timepoints to study on renal safety 5th 10th day of starting treatment

Target Sample Size Total Sample Size=20 Sample Size from India=20 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 1/ Phase 2 Date of First 14/06/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details none Brief Summary

All COVID 19 positive patients who will be admitted in COVID hospital

attached to UPUMS , Saifai will be included in the study provided they fulfil

the inclusion and exclusion criterias. A total of 20 suchAll COVID

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19 positive patients who will be admitted in COVID hospital attached to

UPUMS , Saifai will be included in the study provided they fulfil the

inclusion and exclusion criterias. A total of 20 such patients will be

included in the study. The result of the finding will be compared with other

published literatures to assess the outcome.

patients will be included in the study. The result of the finding will be

compared with other published literatures to assess the outcome.

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