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CompletedNCT04920773Updated Jun 10, 2021

Community-based Post-exposure Prophylaxis for COVID-19

An interventional study of Guduchi Ghanvati and Standard guidelines in Covid19, sponsored by NMP Medical Research Institute. Completed at 2 sites in India. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by NMP Medical Research Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
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Study 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.

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Conditions studied

  • Covid19

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Keywords

  • Post Exposure Prophylaxis
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 216 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

NMP Medical Research Institute is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (actual)

Study arms

  • Experimental
    Ayurveda Care Group

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

    Other: Guduchi Ghanvati · Other: Standard guidelines

  • Active comparator
    Usual Care Group

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

    Other: Standard guidelines

Interventions

  • OtherGuduchi Ghanvati

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

  • OtherStandard guidelines

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

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What researchers measure

Primary outcomes

  1. Number of participants with active COVID-19

    PCR- proven COVID-19

    Time frame: 14-days following exposure

Secondary outcomes

  1. Time to symptoms onset

    Days until start of symptoms of COVID-19

    Time frame: 14-days

  2. Disease Severity

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

    Time frame: 14 days

07

Study locations

2 sites
  • NMP Medical Research Institute
    Jaipur, Rajasthan, India
  • Padmnabham Ayurveda Hospital & Research Center
    Jaipur, Rajasthan, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04920773
Lead sponsor
NMP Medical Research Institute
Collaborators
Aarogyam UK, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India, Padmanabhama Ayurveda Hospital and Research Centre
Responsible party
Sponsor
First posted
Jun 10, 2021
Start date
May 3, 2021
Primary completion
May 21, 2021
Completion
Jun 6, 2021
Last update
Jun 10, 2021

Study contacts

Neha Sharma
study chair · Aarogyam UK
Skanthesh Lakshmanan
study chair · Niramaya clinic, India
Isha Goyal
principal investigator · NMP Medical Research Institute, India
Abijith Venu
study chair · Aarogyam UK
Sahil Singhal
study director · NMP Medical Research Institute
Abhimanyu Kumar
study director · Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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