Community-based Post-exposure Prophylaxis for COVID-19

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Guduchi Ghanvati; Other: Standard guidelines

• Registration Number: NCT04920773
• Lead Sponsor: NMP Medical Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-03
• Primary Completion: 2021-05-21
• Status Verified: 2021-06
• Study Completion: 2021-06-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ayurveda Care Group	Standard guidelines	Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati
Ayurveda Care Group	Guduchi Ghanvati	Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati
Usual Care Group	Standard guidelines	Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask

Primary Outcome Measures

Name	Time	Method
Number of participants with active COVID-19	14-days following exposure	PCR- proven COVID-19

Secondary Outcome Measures

Name	Time	Method
Time to symptoms onset	14-days	Days until start of symptoms of COVID-19
Disease Severity	14 days	Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe)

Trial Locations

Locations (2)

NMP Medical Research Institute; 🇮🇳 Jaipur, Rajasthan, India

Padmnabham Ayurveda Hospital & Research Center; 🇮🇳 Jaipur, Rajasthan, India