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

Sponsor
Aarogyam UK (Other)
Overall Status
Completed
CT.gov ID
NCT04480398
Collaborator
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University (Other), Samta Ayurveda Prakoshtha, India (Other)
91
Enrollment
1
Location
1.7
Actual Duration (Months)
53.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Drug: Guduchi Ghan Vati

Study Design

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 :
Jun 15, 2020
Actual Study Completion Date :
Jul 3, 2020

Arms and Interventions

Arm 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 Names:
  • 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

    Primary Outcome Measures

    1. Virologic clearance [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 [10-days of hospital admission]

      change in the number of patients going from asymptomatic to moderately disease

    2. Hospital Stay [21 days]

      Total duration of stay in hospital for complete recovery

    3. Clinically relevant adverse effects [21-days]

      Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aarogyam UK
    ClinicalTrials.gov Identifier:
    NCT04480398
    Other Study ID Numbers:
    • AYU/DSSR/02
    First Posted:
    Jul 21, 2020
    Last Update Posted:
    Jul 22, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    COVID-19
    Asymptomatic Diseases

    Study Results

    No Results Posted as of Jul 22, 2020