Covid19NCT04716647
Feasibility of Ayurveda in Patients With Mild-to-Moderate COVID-19: A Community-Based Participatory Research
A study testing Ayurveda in people with Covid19, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
Innovative strategies are required to manage COVID-19 in the communities. Back to Roots community based project was a collaborative, pilot intervention program in British Asian community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of mild-to-moderate COVID-19. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Ayurveda
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2020to 18 Dec 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
- With mild or moderate manifestations of COVID-19
- Willing to participate, and consent by signing the informed consent and
- not involved in another clinical trial during the study
Who cannot join
- Patients suffering from severe COVID-19 Disease as per World Health Organisation criteria (REF)
- Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
- Patients with ongoing immunosuppressive therapy for any reasons
- Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
- Pregnancy and lactation
- Ayurveda practitioner decision that involvement in the study is not in the patient's best interest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-Based Participatory Research to Assess the Feasibility of Ayurveda Intervention in Patients With Mild-to-Moderate COVID-19
Innovative strategies are required to manage COVID-19 in the communities. Back to Roots community based project was a collaborative, pilot intervention program in British Asian community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of mild-to-moderate COVID-19.
- Conditions
- Covid19
- Being tested
- Ayurveda
- Keywords
- Ayurveda Intervention, Community Based Participatory Research
- 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
Dosage was used in common range (Ashwagandha: Doses range from 250 mg to 5 g; Giloy: range from 500mg to 1g; Tulsi: 500mg-1g) Dosage were altered based on age, weight and severity of symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda Intervention | Experimental | Ashwagandha, Giloy and Tulsi were given in tablet form for oral administration. Receives: Other: Ayurveda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery
To evaluate the therapeutic efficacy, mean days for clinical recovery were recorded from AiM Covid Application
Measured: Up to 14-days
Proportion of patient with negative conversion in nasopharyngeal swab
To evaluate the therapeutic efficacy, promotion of patients were recorded through AiM Covid application
Measured: Up to 14 days
Secondary outcomes (1)
Clinical Outcome
Clinical Outcome was recorded on 7-pont ordinal scale of COVID-19
Measured: Up 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 Jan 2021
- Study start9 Oct 2020
- Primary completion12 Dec 2020
- Study completion18 Dec 2020
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Community Based Participatory Research
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Study director, Aarogyam UKDipa Modi, Study chair, East Park Medical Centre, NHS trust, LeicesterVishwesh Kulkarni, Principal investigator, University of WarwickAbhimanyu Kumar, Study director, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716647
- Sponsor's protocol ID
- AU/2187
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 20 Jan 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 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-Based Participatory Research to Assess the Feasibility of Ayurveda Intervention in Patients With Mild-to-Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04716647
- Acronym / sponsor ID
- AU/2187
- Conditions
- Covid19
- Keywords
- Ayurveda Intervention, Community Based Participatory Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- University of Warwick, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 20 Jan 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.
Innovative strategies are required to manage COVID-19 in the communities. Back to Roots community based project was a collaborative, pilot intervention program in British Asian community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of mild-to-moderate COVID-19.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Community Based Participatory Research
| Arm | Type | Receives |
|---|---|---|
| Ayurveda Intervention | Experimental | Other: AyurvedaAshwagandha, Giloy and Tulsi were given in tablet form for oral administration. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
- With mild or moderate manifestations of COVID-19
- Willing to participate, and consent by signing the informed consent and
- not involved in another clinical trial during the study
Key exclusion criteria (6 listed)
- Patients suffering from severe COVID-19 Disease as per World Health Organisation criteria (REF)
- Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
- Patients with ongoing immunosuppressive therapy for any reasons
- Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
- Pregnancy and lactation
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 |
|---|---|---|
| AyurvedaDosage was used in common range (Ashwagandha: Doses range from 250 mg to 5 g; Giloy: range from 500mg to 1g; Tulsi: 500mg-1g) Dosage were altered based on age, weight and severity of symptoms. | Other | Ayurveda Intervention |
Primary outcome
Time to clinical recovery
Time frame: Up to 14-days
To evaluate the therapeutic efficacy, mean days for clinical recovery were recorded from AiM Covid Application
Proportion of patient with negative conversion in nasopharyngeal swab
Time frame: Up to 14 days
To evaluate the therapeutic efficacy, promotion of patients were recorded through AiM Covid application
1 secondary outcome
Clinical Outcome
Time frame: Up to 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 20 Jan 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 director
Aarogyam UK
Dipa Modi study chair
East Park Medical Centre, NHS trust, Leicester
Vishwesh Kulkarni principal investigator
University of Warwick
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 Covid19, run by Aarogyam UK 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 4 inclusion and 6 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 20 Jan 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 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?
Time to clinical recovery (time frame: Up to 14-days). The study lists 2 primary outcomes in all. 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 20 Jan 2021.