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OpenTrials
Completed

NCT Number: NCT04920773

Community-based Post-exposure Prophylaxis for COVID-19

Specifically identified Ayurvedic preparations is recommended by ministry of AYUSH as post-exposure prophylaxis to efficaciously prevent a negative person who has come into contact with COVID-19-positive. Traditionally, recommended Ayurvedic preparations have been used as antioxidants, antimicrobial and anti-inflammatory properties. Particularly, Guduchi Ghanvati has been recognised with its ability to control viral attachment, viral replication and induce immune response in pre clinical settings, and found to be one among the most important drugs in Ayurveda to fight against COVID-19.

However, known gap in guideline implementation and its impact on preventing active infection in exposed cases is unclear. Study aimed to increase the use of recommended AYUSH guidelines by having registered AYUSH physicians provide these medications, when indicated, in community based participants after known exposure to the SARS-CoV-2 coronavirus.

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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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NMP Medical Research Institute, Jaipur, Rajasthan, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men or women 18 to 60 years of age
  • Household contact residing with the index case in the 14 days prior to index diagnosis within a residence without maintaining social distance
  • Access to device and internet for telephonic appointments and follow up

Exclusion criteria

  • Currently hospitalised
  • Symptomatic with fever, cough, or shortness of breath
  • Use of anti-malarial treatment or chemoprophylaxis
  • Moderately or Severely ill for any co-morbid condition requiring medical assistance.
  • Cognitive impairment

Treatment and study plan

Guduchi Ghanvati

Other

500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily

Standard guidelines

Other

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Primary outcomes

  1. Number of participants with active COVID-19

    Time frame: 14-days following exposure

    PCR- proven COVID-19

Secondary outcomes

  1. Time to symptoms onset

    Time frame: 14-days

    Days until start of symptoms of COVID-19

  2. Disease Severity

    Time frame: 14 days

    Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Sponsors and collaborators

Lead sponsor

NMP Medical Research Institute

Other

Collaborators

  • Aarogyam UK
  • Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
  • Padmanabhama Ayurveda Hospital and Research Centre
  • Samta Ayurveda Prakoshtha, India

Registry information

Official study title

Community-based Post-exposure Prophylaxis for COVID-19: Results and Implications of Ayurveda Practice Guidelines

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

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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