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

July 21, 2020 updated by: Aarogyam UK

A Retrospective Study on Efficacy and Safety of Guduchi Ghan Vati for Covid-19 Asymptomatic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jodhpur, Rajasthan, India
        • Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Covid-19 Confirmed Asymptomatic patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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 Names:
  • Giloy Ghan Vati
Control
Standard care for asymptomatic confirmed cases is isolation (to contain virus transmission) and clinical monitoring as per recommended Guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10-days of hospital admission
Hospital Stay
Time Frame: 21 days
Total duration of stay in hospital for complete recovery
21 days
Clinically relevant adverse effects
Time Frame: 21-days
Clinically relevant adverse effects of Guduchi Ghan Vati (Disability, Discomfort reported)
21-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarogyam UK

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

July 3, 2020

Study Registration Dates

First Submitted

July 18, 2020

First Submitted That Met QC Criteria

July 18, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AYU/DSSR/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on Guduchi Ghan Vati

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe