Community-based Post-exposure Prophylaxis for COVID-19

NMP Medical Research Institute

Status: Completed

Conditions: Covid19

Treatments: Other: Guduchi Ghanvati; Other: Standard guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT04920773

NMP/CARE/01

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Ayurveda Care Group

Experimental group

Description:

Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati

Treatment:

Other: Guduchi Ghanvati

Other: Standard guidelines

Usual Care Group

Active Comparator group

Description:

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

Treatment:

Other: Standard guidelines