<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04480398</url>
  </required_header>
  <id_info>
    <org_study_id>AYU/DSSR/02</org_study_id>
    <nct_id>NCT04480398</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients</brief_title>
  <official_title>A Retrospective Study on Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarogyam UK</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samta Ayurveda Prakoshtha, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarogyam UK</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronavirus disease 2019 (Covid-19) has been declared global emergency with immediate safety,&#xD;
      preventative and curative measures to control the spread of virus. Confirmed cases are&#xD;
      treated with clinical management as they are diagnosed but so far, there is no effective&#xD;
      treatment or vaccine yet for Covid-19.&#xD;
&#xD;
      With recommended guidelines of AYUSH Ministry, India, the use of Ayurveda for Covid-19 has&#xD;
      increased; however, its efficacy and safety in Covid-19 confirmed patients remain unclear.&#xD;
&#xD;
      Present study examined the efficacy and safety of one of the recommended Ayurveda drug&#xD;
      (Guduchi Ghan Vati) compared with standard care for patients with asymptomatic Covid-19&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Actual">July 3, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virologic clearance</measure>
    <time_frame>21 days</time_frame>
    <description>Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the number of patients going from asymptomatic to moderately disease</measure>
    <time_frame>10-days of hospital admission</time_frame>
    <description>change in the number of patients going from asymptomatic to moderately disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Stay</measure>
    <time_frame>21 days</time_frame>
    <description>Total duration of stay in hospital for complete recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant adverse effects</measure>
    <time_frame>21-days</time_frame>
    <description>Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">91</enrollment>
  <condition>Covid19</condition>
  <condition>Asymptomatic Condition</condition>
  <arm_group>
    <arm_group_label>Ayurveda</arm_group_label>
    <description>Guduchi Ghan Vati was given to Covid patients 2 tablets (500 mg each) twice daily were given orally after meal for 28 days. Guduchi ghan vati is a powdered aqueous extract of Tinospora cordifolia in tablet form and prepared in GMP certified Pharmacy of the University, following standard protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guduchi Ghan Vati</intervention_name>
    <description>Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.</description>
    <arm_group_label>Ayurveda</arm_group_label>
    <other_name>Giloy Ghan Vati</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Covid-19 Confirmed Asymptomatic patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  A person diagnosed with COVID-19&#xD;
&#xD;
          -  Asymptomatic at the time of admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients over 75 years&#xD;
&#xD;
          -  Taking antibiotics or antiretroviral for any reason&#xD;
&#xD;
          -  Mild to Moderate symptoms at the time of hospital admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Parashar Sharma</last_name>
    <role>Study Chair</role>
    <affiliation>Samta Ayurveda Prakoshtha</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaydeep Joshi</last_name>
    <role>Study Chair</role>
    <affiliation>Aarogyam UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neha Sharma</last_name>
    <role>Study Director</role>
    <affiliation>Aarogyam UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abhimanyu Kumar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University</name>
      <address>
        <city>Jodhpur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ayurveda</keyword>
  <keyword>Guduchi Ghan Vati</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Asymptomatic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04480398
org study id: AYU/DSSR/02
nct id: NCT04480398
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (Covid-19) has been declared global emergency with immediate safety,
      preventative and curative measures to control the spread of virus. Confirmed cases are
      treated with clinical management as they are diagnosed but so far, there is no effective
      treatment or vaccine yet for Covid-19.

      With recommended guidelines of AYUSH Ministry, India, the use of Ayurveda for Covid-19 has
      increased; however, its efficacy and safety in Covid-19 confirmed patients remain unclear.

      Present study examined the efficacy and safety of one of the recommended Ayurveda drug
      (Guduchi Ghan Vati) compared with standard care for patients with asymptomatic Covid-19
      patients.
observational model: Cohort
time perspective: Retrospective
measure: Virologic clearance
time frame: 21 days
description: Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result
measure: Change in the number of patients going from asymptomatic to moderately disease
time frame: 10-days of hospital admission
description: change in the number of patients going from asymptomatic to moderately disease
measure: Hospital Stay
time frame: 21 days
description: Total duration of stay in hospital for complete recovery
measure: Clinically relevant adverse effects
time frame: 21-days
description: Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)
arm group label: Ayurveda
description: Guduchi Ghan Vati was given to Covid patients 2 tablets (500 mg each) twice daily were given orally after meal for 28 days. Guduchi ghan vati is a powdered aqueous extract of Tinospora cordifolia in tablet form and prepared in GMP certified Pharmacy of the University, following standard protocol.
arm group label: Control
description: Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines.
intervention type: Drug
intervention name: Guduchi Ghan Vati
description: Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.
arm group label: Ayurveda
other name: Giloy Ghan Vati
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Parashar Sharma
role: Study Chair
affiliation: Samta Ayurveda Prakoshtha
last name: Jaydeep Joshi
role: Study Chair
affiliation: Aarogyam UK
last name: Neha Sharma
role: Study Director
affiliation: Aarogyam UK
last name: Abhimanyu Kumar
role: Principal Investigator
affiliation: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
facility: 
country: India
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Asymptomatic Diseases
sharing ipd: Undecided