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

Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 05:16:11 GMT)

CTRI Number CTRI/2020/06/025637 [Registered on: 05/06/2020] - Trial Registered Prospectively Last Modified On 05/06/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Ayurveda Study Design Cluster Randomized Trial Public Title of Study As the present outbreak of novel coronavirus in Indian scenario we want to study about the prophylactic study in Distric Hospital, . Scientific Title of Indian Ancient system for the prophylaxis of COVID-19 Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sarvesh Sharma Trial Coordinator (multi-center study) Designation Pharmacist Affiliation District Hospital Address Department of Pharmacy Room No 138 NH-86, Road , Near Vivekanand Square Vidisha SMS, DH, Vidisha Department of Pharmacy Room No 138 NH-86, Bhopal Road , Near Vivekanand Square Vidisha Vidisha 464001 Phone 9893194659 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sarvesh Sharma Query) Designation Pharmacist Affiliation DH, Vidisha Address SMS, DH, Department of Pharmacy Room no 138 NH-86, Bhopal Road , Near Vivekanand Square Vidisha SMS, DH, Department of Pharmacy Room no 138 NH-86, Bhopal Road , Near Vivekanand Square Vidisha Vidisha MADHYA PRADESH 464001 India Phone 9893194659 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sarvesh Sharma Designation Pharmacist Affiliation DH, Vidisha Address SMS, DH, Vidisha Department of Pharmacy Room No138 NH-86, Bhopal Road , Near Vivekanand Square Vidisha SMS, DH, Vidisha Department of Pharmacy Room No138 NH-86, Bhopal Road , Near

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Vivekanand Square Vidisha Vidisha MADHYA PRADESH 464001 India Phone 9893194659 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > self designed and financed Primary Sponsor Primary Sponsor Details Name ABVMC RC VIDISHA Address NH 86 Bhopal Road Vivekanand Square Vidisha 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 sarvesh sharma District Hospital Department of 9893194659 Pharmacy Room No 138 NH-86 Bhopal [email protected] Road Vidisha m Vidisha MADHYA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? MC HEC Approved 10/05/2020 No Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers healthy Intervention / Type Name Details Comparator Agent Intervention Piper betal with the combination ! leaf of piper betal and 01 mg of of swarnabhasma (Herbo swarna bhasma in herbal mineral combination) presentation thrice in a day Inclusion Criteria Inclusion Criteria Age From 24.00 Year(s) Age To 54.00 Year(s) Gender Both Details All are healthy human involve for study purpose Exclusion Criteria Exclusion Criteria Details Abnormal symptoms if comes they excluded from the study Method of Generating Adaptive randomization, such as minimization Random Sequence Method of Pharmacy-controlled Randomization Concealment Blinding/Masking Participant and Investigator Blinded

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Primary Outcome Outcome Timepoints Parameter will test :Complete blood every 3 day with baseline up to 8 week picture,Serum ferritin,C-reactive protein,LDH,Troponin, Nucleic acid amplification test and RT-PCR Secondary Outcome Outcome Timepoints pathological investigation with same variable up 6 month to 1 year. Target Sample Size Total Sample Size=10 Sample Size from India=10 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 22/06/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=6 Days=30 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL Brief Summary Corona virus (COVID-19) is an enveloped RNA virus that is diversely initiated in humans and wildlife. An entirety of six species has been identified to cause disease in humans. Viral infections participate a vital role in human diseases, and recent outbreaks is the influx globally in form of novel corona .The SS-RNA virus from the enveloped corona virus family caused SARS (Severe acute respiratory syndrome) which is life threatening viral infection. The spreading of infection is rapid in many countries of the world. As of March 26, 2020, there have been 462,684 confirmed cases globally, and 20,834 deaths have been registered. The World Health Organization (WHO) called COVID-19 a pandemic on March 11, 2020. In Ayurveda pandemics are called as janapadodhvansa roga. Coronavirus is an example of the latter. Janapadodhvansa literally means “annihilation of society”. Swarna Bhasma is an proficient dosage form in the Ayurvedic treatment. In the conventional system of medicine some molecules of Gold are skillful for executive of various disorders. Various Sanskrit texts describe the medicinal uses of the heart shaped betel leaves. Leaves of Piper betel rich sources of numerous phytoceuticals and are used in traditional medicinal systems. Many investigation studies on Piper betle has reported its therapeutic properties like anti-malaria, antibacterial, antifungal, anti-diabetic, anti-platelet anti-allergic, oral

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hygiene and anti-asthmatic effect and wound healing. The present review based on previous outcome of various pharmacological activity of both herbal (Piper betle) and herbo-mineral (Swarna Bhasma) to illustrated the proposed mechanism of the combination of both may be used can be used as prophylaxis and therapeutic treatment for corona patient.

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