Covid-19NCT04395976
Ayurveda as Prophylaxis for Suspected COVID-19 Patients
A study testing Ayurveda in people with Covid-19, run by British Ayurvedic Medical Council at 1 site in United Kingdom.
Trial summary
Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- Ayurveda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2020to 1 Sep 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person who has come into contact with confirmed COVID-19,
- Willing to take study drug as directed
Who cannot join
- Confirmed current COVID-19
- Inability to take medications orally
- Inability to provide written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ayurveda as Prophylaxis for Suspected Covid-19 Patients: Randomised Controlled Trial
Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Recent developments on the use of traditional medicines in Covid-19 management has drawn enough attention to start several research studies. Based on the Indian Traditional Medicine, Ayurveda's community initiatives, preliminary studies, and our experiential knowledge on Covid-19 settings, we propose present study to prevent the development of COVID-19 symptoms in people who live or have come contact with an individual diagnosed with COVID-19.
- Conditions
- Covid-19
- Being tested
- Ayurveda
- Keywords
- Ayurveda
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyurvedaOther
The Ayurveda intervention is multimodal and following the principles of Ayurveda as a whole medical system, each participants will be treated with individualised care. From the range of proven Ayurvedic Herbs, combination will be decided based on individual participants, his symptoms and his personality.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants randomised into the control group receive conventional standard care given by recommended guideline. |
| Ayurveda | Experimental | Treatment includes a tailored combination of herbs based on individual constitution (based on Ayurveda) nutritional advice, specific consideration of selected food items, specific lifestyle advice, yoga advice along with standard recommendations. Receives: Other: Ayurveda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical confirmation of Covid-19
Number of participants with symptomatic, lab-confirmed COVID-19
Measured: From date of enrolment to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start10 May 2020
- Primary completion10 Jun 2020
- Study completion1 Sep 2020
Why it stopped: Ethical approval was denied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Ayurvedic Medical Council
- Sponsor type
- University, hospital or other
- Collaborators
- All Party Parliamentary Group - Indian Traditional Sciences, University of Warwick
- Responsible party
- Sponsor
- Investigators
- Vishwes Kulkarni, Principal investigator, University of WarwickAmarjeet S Bhamra, Study chair, All Party Parliamentary Group - Indian Traditional SciencesNeha Sharma, Study director, British Ayurvedic Medical Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395976
- Sponsor's protocol ID
- BAMC01
- Status last verified
- Feb 2021
- First submitted
- 19 May 2020
- Last updated
- 2 Mar 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 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ayurveda as Prophylaxis for Suspected Covid-19 Patients: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04395976
- Acronym / sponsor ID
- BAMC01
- Conditions
- Covid-19
- Keywords
- Ayurveda
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Ethical approval was denied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- British Ayurvedic Medical CouncilUniversity, hospital or other
- Collaborators
- All Party Parliamentary Group - Indian Traditional Sciences, University of Warwick
- Study start
- 10 May 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 20 May 2020 (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.
Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Recent developments on the use of traditional medicines in Covid-19 management has drawn enough attention to start several research studies. Based on the Indian Traditional Medicine, Ayurveda's community initiatives, preliminary studies, and our experiential knowledge on Covid-19 settings, we propose present study to prevent the development of COVID-19 symptoms in people who live or have come contact with an individual diagnosed with COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants randomised into the control group receive conventional standard care given by recommended guideline. |
| Ayurveda | Experimental | Other: AyurvedaTreatment includes a tailored combination of herbs based on individual constitution (based on Ayurveda) nutritional advice, specific consideration of selected food items, specific lifestyle advice, yoga advice along with standard recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Person who has come into contact with confirmed COVID-19,
- Willing to take study drug as directed
Key exclusion criteria (3 listed)
- Confirmed current COVID-19
- Inability to take medications orally
- Inability to provide written consent
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 |
|---|---|---|
| AyurvedaThe Ayurveda intervention is multimodal and following the principles of Ayurveda as a whole medical system, each participants will be treated with individualised care. From the range of proven Ayurvedic Herbs, combination will be decided based on individual participants, his symptoms and his personality. | Other | Ayurveda |
Primary outcome
Clinical confirmation of Covid-19
Time frame: From date of enrolment to 14 days
Number of participants with symptomatic, lab-confirmed COVID-19
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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.
Vishwes Kulkarni principal investigator
University of Warwick
Amarjeet S Bhamra study chair
All Party Parliamentary Group - Indian Traditional Sciences
Neha Sharma study director
British Ayurvedic Medical Council
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayurveda in people with Covid-19, run by British Ayurvedic Medical Council at 1 site in United Kingdom.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical confirmation of Covid-19 (time frame: From date of enrolment to 14 days). 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 2 Mar 2021.