Flu Like SymptomNCT04345549
Ayurveda Self-Management for Flu Like Symptoms During the Covid-19 Outbreak
A study testing Individualised Ayurveda in people with Flu Like Symptom and Flu Like Illness, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom (UK). During the same time, seasonal flu continued to circulate across the UK. With similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Flu Like Symptom, Flu Like Illness
- What is being tested?
- Individualised Ayurveda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2020to 30 Mar 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
- Willing to consent and follow up
Who cannot join
- Pregnant/lactating
- Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
- Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ayurveda Self-Management for Flu Like Symptoms in People Self-Isolated for 7 Days During the Coronavirus Disease 2019 (COVID-19) Outbreak
From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom (UK). During the same time, seasonal flu continued to circulate across the UK. With similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. Present study aimed to evaluate the effect of self-managed Ayurveda on flu like symptoms in people who self-isolated at home for 7-days in March 2020 during the Covid-19 outbreak in UK.
- Conditions
- Flu Like Symptom, Flu Like Illness
- Being tested
- Individualised Ayurveda
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised AyurvedaOther
Saline warm water gargle, Steam, Paracetamol for body temperature and plenty fluid and rest, Food and herbs recommendation as per individual Ayurveda constitution, Using Ginger/ lemon/ turmeric/ honey recommended as per individual, Yoga breathing
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda | Experimental | All the participants were advised to self-isolate for 7-days and maintain hygiene and self-care as per recommended guidelines. Along with that, participants were advised to constitution based Ayurveda treatment using herbs, life style and yoga. Receives: Other: Individualised Ayurveda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve afebrile
Time to bring down a fever (oral temperature < 37.2˚C)
Measured: From Baseline to 3rd and 7th-days of intervention
Secondary outcomes (1)
Severity of influenza symptom score
Symptoms diary card completed twice daily from Day 0 to Day 7
Measured: Twice daily from Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start26 Feb 2020
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flu Like SymptomStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Principal investigator, Aarogyam UKJaydeep Joshi, Study director, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345549
- Sponsor's protocol ID
- AU08
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ayurveda Self-Management for Flu Like Symptoms in People Self-Isolated for 7 Days During the Coronavirus Disease 2019 (COVID-19) Outbreak
- ClinicalTrials.gov ID
- NCT04345549
- Acronym / sponsor ID
- AU08
- Conditions
- Flu Like Symptom, Flu Like Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 14 Apr 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.
From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom (UK). During the same time, seasonal flu continued to circulate across the UK. With similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. Present study aimed to evaluate the effect of self-managed Ayurveda on flu like symptoms in people who self-isolated at home for 7-days in March 2020 during the Covid-19 outbreak in UK.
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: Individualised AyurvedaAll the participants were advised to self-isolate for 7-days and maintain hygiene and self-care as per recommended guidelines. Along with that, participants were advised to constitution based Ayurveda treatment using herbs, life style and yoga. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
- Willing to consent and follow up
Key exclusion criteria (3 listed)
- Pregnant/lactating
- Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
- Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances
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 |
|---|---|---|
| Individualised AyurvedaSaline warm water gargle, Steam, Paracetamol for body temperature and plenty fluid and rest, Food and herbs recommendation as per individual Ayurveda constitution, Using Ginger/ lemon/ turmeric/ honey recommended as per individual, Yoga breathing | Other | Ayurveda |
Primary outcome
Time to achieve afebrile
Time frame: From Baseline to 3rd and 7th-days of intervention
Time to bring down a fever (oral temperature < 37.2˚C)
1 secondary outcome
Severity of influenza symptom score
Time frame: Twice daily from Day 1 to Day 7
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 Apr 2020.
Related trials for Flu Like Symptom
Not yet recruiting
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
Respiratory Tract Infections (RTI), Influenza-like Illness
RecruitingObservational study
The Fever Clinic Acute Respiratory Cohort
Acute Respiratory Infections, Febrile Illnesses
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 principal investigator
Aarogyam UK
Jaydeep Joshi study director
Aarogyam UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised Ayurveda in people with Flu Like Symptom and Flu Like Illness, 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 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: finished, as of the sponsor's last update on 14 Apr 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 achieve afebrile (time frame: From Baseline to 3rd and 7th-days of intervention). 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 Apr 2020.