Covid-19NCT04387643
Protecting Health Care Workers During the COVID-19 Outbreak
An observational study of Covid-19, run by Aarogyam UK at 1 site in India.
Trial summary
Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February 2020. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- Ayurvedic Kadha
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2020to 2 Apr 2020
- Phase
- Observational
- 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
Study population: Health care workers at front line of Covid-19 screening, treatment and management
Who may be able to join
- Health care workers posted in Covid-19 duties at front line
- Health workers who had Ayurveda herbs combination over for at least 10-days
Who cannot join
- No willing to consent
- inability to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protecting Health Care Workers During the COVID-19 Outbreak:Qualitative Study of AYUSH Initiative
Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February 2020. Then, majority of these health care workers were put on front line managing screening, monitoring, quarantine and treating Covid 19 patients. This real-life study aimed to determine the experience of health care workers who had Ayurveda kadha before starting as front-line workers.
- Conditions
- Covid-19
- Being tested
- Ayurvedic Kadha
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayurvedic KadhaDietary supplement
Kadha (also called Kwath and Kashaya) is a type of ayurvedic formulation prepared by boiling herbs in water. Water and herbs are main ingredients of these preparations. The preparation of Kadha uses dry herbs, which are dried under the sun or in the shade, as directed for the individual herb. Then, the herbs are pounded to form a coarse powder
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Health
Self-reported health issues
Measured: From baseline to 30-days
Psychological Health
Self-reported psychological issues
Measured: From baseline to 30-days
Secondary outcomes (2)
Coping with distress
Self-reported coping with high demanding work in Covid-19 duties
Measured: From baseline to 30-days
Self-Help
Self reported self-help measures used
Measured: From baseline to 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Mar 2020
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- Samta Ayurveda Prakoshtha, India
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Study chair, British Ayurvedic Medical Council (UK)Jaydeep Joshi, Study director, Aarogyam UKParashar Sharma, Study director, Samta Ayurveda Prakoshtha, IndiaSahil Singhal, Principal investigator, Samta Ayurveda Prakoshtha, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387643
- Sponsor's protocol ID
- AU/SA/01
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 14 May 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 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protecting Health Care Workers During the COVID-19 Outbreak:Qualitative Study of AYUSH Initiative
- ClinicalTrials.gov ID
- NCT04387643
- Acronym / sponsor ID
- AU/SA/01
- Conditions
- Covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- Samta Ayurveda Prakoshtha, India
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 14 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.
Preparing to deal with Covid-19 outbreak in Rajasthan, India, health care workers were given Ayurvedic Kadha (combination of ayurvedic herbal extracts) starting from the end of February 2020. Then, majority of these health care workers were put on front line managing screening, monitoring, quarantine and treating Covid 19 patients. This real-life study aimed to determine the experience of health care workers who had Ayurveda kadha before starting as front-line workers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Health care workers at front line of Covid-19 screening, treatment and management
Key inclusion criteria (2 listed)
- Health care workers posted in Covid-19 duties at front line
- Health workers who had Ayurveda herbs combination over for at least 10-days
Key exclusion criteria (2 listed)
- No willing to consent
- inability to participate
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 |
|---|---|---|
| Ayurvedic KadhaKadha (also called Kwath and Kashaya) is a type of ayurvedic formulation prepared by boiling herbs in water. Water and herbs are main ingredients of these preparations. The preparation of Kadha uses dry herbs, which are dried under the sun or in the shade, as directed for the individual herb. Then, the herbs are pounded to form a coarse powder | Dietary supplement | – |
Primary outcome
Physical Health
Time frame: From baseline to 30-days
Self-reported health issues
Psychological Health
Time frame: From baseline to 30-days
Self-reported psychological issues
2 secondary outcomes
Coping with distress
Time frame: From baseline to 30-days
Self-Help
Time frame: From baseline to 30-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 14 May 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.
Neha Sharma study chair
British Ayurvedic Medical Council (UK)
Jaydeep Joshi study director
Aarogyam UK
Parashar Sharma study director
Samta Ayurveda Prakoshtha, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by Aarogyam UK at 1 site 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 2 inclusion and 2 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 14 May 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 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?
Physical Health (time frame: From baseline to 30-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 14 May 2020.