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OpenTrials
Completed

NCT Number: NCT04542876

Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur, Rajasthan, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guduchi Ghan Vati

Drug

Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.

Other names: Giloya, Amrita, Tinosporia Cordifolus, Guduchi

Primary outcomes

  1. 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

  1. Hospital Stay

    Time frame: 14 days

    Total duration of stay in hospital for complete recovery

  2. Clinically relevant adverse effects

    Time frame: 14 days

    Clinically relevant adverse effects of Guduchi Ghan Vati were reported using Adverse Drug Reaction reporting form

  3. Laboratory tests

    Time frame: change from baseline to 14 days

    Routine blood tests were performed to assess complete blood counts, blood biochemistry parameters {Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Urea, C-reactive protein (CRP), as well as Albumin} and immunoglobulines.

Sponsors and collaborators

Lead sponsor

Aarogyam UK

Other

Collaborators

  • Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2020
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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