Covid19NCT04621903
A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19
A study of Covid19, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Covid19
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2020to 3 Nov 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 period
Who cannot join
- Patients suffering from severe COVID-19 Disease as judged by WHO 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 for example solid organ transplantation, autoimmune diseases or cancer.
- Patients with known long term infection like HIV
- 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 Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19: Community Based Participatory Research
The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach.
CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.
- Conditions
- Covid19
- Being tested
- Shanshamani Vati Plus
- Keywords
- Ayurveda, Shanshamani Vati Plus
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shanshamani Vati PlusOther
Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda | Experimental | Not described Receives: Other: Shanshamani Vati Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to COVID-19 symptoms relief
Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale
Measured: Up to 14-days
Prevention of severe stage of Covid19
Deterioration in clinical status from mild/moderate to severe/critical during the study period assessed by AiM COVID-19 App
Measured: Up to 14-days
Secondary outcomes (3)
Side effect/ adverse events
Number of participants with intervention-related side effect/ adverse events as assessed by AiM COVID-19 App
Measured: Up to 14-days
COVID-19 severity worsening
Number of participants requiring hospitalisation
Measured: Up to 14-days
Time to negative saliva
Time to positive-to-negative RT-PCR conversion
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 posted9 Nov 2020
- Study start8 Oct 2020
- Primary completion27 Oct 2020
- Study completion3 Nov 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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warwick, All India Institute of Ayurveda, Ministry of AYUSH, Government of India
- Responsible party
- Sponsor
- Investigators
- Vishwesh Kulkarni, Principal investigator, University of WarwickNeha Sharma, Study director, Aarogyam UKDipa Modi, Study chair, East Park Medical Centre, Leicester NHS TrustTanuja Nesari, Principal investigator, All India Institute of Ayurveda, Ministry of AYUSH, Government of India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621903
- Sponsor's protocol ID
- AU/WU/ 06
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19: Community Based Participatory Research
- ClinicalTrials.gov ID
- NCT04621903
- Acronym / sponsor ID
- AU/WU/ 06
- Conditions
- Covid19
- Keywords
- Ayurveda, Shanshamani Vati Plus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- University of Warwick, All India Institute of Ayurveda, Ministry of AYUSH, Government of India
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 9 Nov 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.
The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach.
CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ayurveda | Experimental | Other: Shanshamani Vati Plus |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 period
Key exclusion criteria (7 listed)
- Patients suffering from severe COVID-19 Disease as judged by WHO 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 for example solid organ transplantation, autoimmune diseases or cancer.
- Patients with known long term infection like HIV
- Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
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 |
|---|---|---|
| Shanshamani Vati PlusShanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily. | Other | Ayurveda |
Primary outcome
Time to COVID-19 symptoms relief
Time frame: Up to 14-days
Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale
Prevention of severe stage of Covid19
Time frame: Up to 14-days
Deterioration in clinical status from mild/moderate to severe/critical during the study period assessed by AiM COVID-19 App
3 secondary outcomes
Side effect/ adverse events
Time frame: Up to 14-days
COVID-19 severity worsening
Time frame: Up to 14-days
Time to negative saliva
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 19 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Vishwesh Kulkarni principal investigator
University of Warwick
Neha Sharma study director
Aarogyam UK
Dipa Modi study chair
East Park Medical Centre, Leicester NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 3 inclusion and 7 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 19 Nov 2020. 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 COVID-19 symptoms relief (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 19 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.