Covid19NCT04920773
Community-based Post-exposure Prophylaxis for COVID-19
A study testing Guduchi Ghanvati and Standard guidelines in people with Covid19, run by NMP Medical Research Institute at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Guduchi Ghanvati and Standard guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesIndia
- Study dates
- 3 May 2021to 6 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
India2 sites
NMP Medical Research Institute
Jaipur, Rajasthan
Padmnabham Ayurveda Hospital & Research Center
Jaipur, Rajasthan
About this study
Official title: Community-based Post-exposure Prophylaxis for COVID-19: Results and Implications of Ayurveda Practice Guidelines
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.
- Conditions
- Covid19
- Being tested
- Guduchi Ghanvati, Standard guidelines
- Keywords
- Post Exposure Prophylaxis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guduchi GhanvatiOther
500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily
Standard guidelinesOther
Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda Care Group | Experimental | Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati Receives: Other: Guduchi Ghanvati; Other: Standard guidelines |
| Usual Care Group | Active comparator | Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Receives: Other: Standard guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with active COVID-19
PCR- proven COVID-19
Measured: 14-days following exposure
Secondary outcomes (2)
Time to symptoms onset
Days until start of symptoms of COVID-19
Measured: 14-days
Disease Severity
Visual Analog Scale of rating overall symptom severity (0 = no symptoms; 10 = most severe)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start3 May 2021
- Primary completion21 May 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Aarogyam UK, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India, Padmanabhama Ayurveda Hospital and Research Centre
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Study chair, Aarogyam UKSkanthesh Lakshmanan, Study chair, Niramaya clinic, IndiaIsha Goyal, Principal investigator, NMP Medical Research Institute, IndiaAbijith Venu, Study chair, Aarogyam UKSahil Singhal, Study director, NMP Medical Research InstituteAbhimanyu Kumar, Study director, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920773
- Sponsor's protocol ID
- NMP/CARE/01
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Post-exposure Prophylaxis for COVID-19: Results and Implications of Ayurveda Practice Guidelines
- ClinicalTrials.gov ID
- NCT04920773
- Acronym / sponsor ID
- NMP/CARE/01
- Conditions
- Covid19
- Keywords
- Post Exposure Prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Aarogyam UK, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Samta Ayurveda Prakoshtha, India, Padmanabhama Ayurveda Hospital and Research Centre
- Study start
- 3 May 2021 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurveda Care Group | Experimental | Other: Guduchi Ghanvati, Other: Standard guidelinesPractice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask Samshamani vati or Giloy Ghanavati |
| Usual Care Group | Active comparator | Other: Standard guidelinesPractice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guduchi Ghanvati500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily | Other | Ayurveda Care Group |
| Standard guidelinesPractice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask | Other | Ayurveda Care Group, Usual Care Group |
Primary outcome
Number of participants with active COVID-19
Time frame: 14-days following exposure
PCR- proven COVID-19
2 secondary outcomes
Time to symptoms onset
Time frame: 14-days
Disease Severity
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma study chair
Aarogyam UK
Skanthesh Lakshmanan study chair
Niramaya clinic, India
Isha Goyal principal investigator
NMP Medical Research Institute, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guduchi Ghanvati and Standard guidelines in people with Covid19, run by NMP Medical Research Institute at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with active COVID-19 (time frame: 14-days following exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.