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Clinical Trials/NCT04542876
NCT04542876CompletedNot Applicable

Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study

Aarogyam UK1 site in 1 country46 target enrollmentStarted: May 1, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
46
Locations
1
Primary Endpoint
Virologic clearance
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.Therefore, present feasibility study of the safety and efficacy of Guduchi Ghan Vati was conducted in asymptomatic patients with COVID-19

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All hospitalised cases above 18 years of age,
  • •Diagnosed with Covid-19
  • •Asymptomatic at the time of admission
  • •Agree to give consent

Exclusion Criteria

  • •Symptoms relating to Covid-19
  • •Severe vomiting
  • •Respiratory failure or requiring mechanical ventilation
  • •Patients having alanine transaminase (ALT) or aspartate transaminase (AST) > 5 times the upper range of normal limits
  • •Patients with Covid-19 in critical condition or ARDS or NIAD 8 -point ordinal score-2
  • •Patients with uncontrolled diabetes mellitus
  • •Malignant,
  • •Chronic renal failure or
  • •On immunosuppressive medication

Arms & Interventions

Ayurveda

Experimental

Guduchi Ghana is a unique Ayuvedic classical preparation prepared from aqueous extracts of Tinospora cordifolia stem.

Intervention: Guduchi Ghan Vati (Drug)

Outcomes

Primary Outcomes

Virologic clearance

Time Frame: 14 days

Virologic clearance indicates the duration from the first Covid-19 positive result to the first Covid-19 negative result

Secondary Outcomes

  • Clinically relevant adverse effects(14 days)
  • Hospital Stay(14 days)
  • Laboratory tests(change from baseline to 14 days)

Investigators

Sponsor
Aarogyam UK
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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