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Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480398
Recruitment Status : Completed
First Posted : July 21, 2020
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Samta Ayurveda Prakoshtha, India
Information provided by (Responsible Party):
Aarogyam UK

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Covid19 Asymptomatic Condition Drug: Guduchi Ghan Vati

Study Design
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Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study on Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients
Actual Study Start Date : May 12, 2020
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : July 3, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Ayurveda
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.
 Drug: Guduchi Ghan Vati
Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.
Other Name: Giloy Ghan Vati
Control
Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines.


Outcome Measures
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Primary Outcome Measures :
  1. Virologic clearance [ Time Frame: 21 days ]
    Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result


Secondary Outcome Measures :
  1. Change in the number of patients going from asymptomatic to moderately disease [ Time Frame: 10-days of hospital admission ]
    change in the number of patients going from asymptomatic to moderately disease

  2. Hospital Stay [ Time Frame: 21 days ]
    Total duration of stay in hospital for complete recovery

  3. Clinically relevant adverse effects [ Time Frame: 21-days ]
    Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Covid-19 Confirmed Asymptomatic patients
Criteria

Inclusion Criteria:

  • Age over 18
  • A person diagnosed with COVID-19
  • Asymptomatic at the time of admission

Exclusion Criteria:

  • Patients over 75 years
  • Taking antibiotics or antiretroviral for any reason
  • Mild to Moderate symptoms at the time of hospital admission
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480398


Locations
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India
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur, Rajasthan, India
Sponsors and Collaborators
Aarogyam UK
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Samta Ayurveda Prakoshtha, India
Investigators
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Study Chair: Parashar Sharma Samta Ayurveda Prakoshtha
Study Chair: Jaydeep Joshi Aarogyam UK
Study Director: Neha Sharma Aarogyam UK
Principal Investigator: Abhimanyu Kumar Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
More Information
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Responsible Party: Aarogyam UK
ClinicalTrials.gov Identifier: NCT04480398    
Other Study ID Numbers: AYU/DSSR/02
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aarogyam UK:
Ayurveda
Guduchi Ghan Vati
Additional relevant MeSH terms:
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Asymptomatic Diseases
Disease Attributes
Pathologic Processes