Flu Like IllnessNCT04351542
Ayurveda for Flu Like Illness During Covid-19 Outbreak
A study testing Ayurveda in people with Flu Like Illness, run by Aarogyam UK at 1 site in United Kingdom.
Trial summary
This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Flu Like Illness
- What is being tested?
- Ayurveda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2020to 12 Apr 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
- Patients with fu like symptoms within 48 hours of onset during March2020
- Mild to moderate symptoms who were advised to self isolate at home for 7-14 days
- 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
- Severe symptoms of respiratory distress patients deemed to require intensive care immediately
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ayurveda for Flu-like Illness During the Covid 19 Outbreak: Non Randomised Single-blind Controlled Trial
This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.
- Conditions
- Flu Like Illness
- Being tested
- Ayurveda, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyurvedaDietary supplement
Based on individual constitution (ayurveda based assessment) and symptoms an individual has, ayurveda herbal supplement and self managed practices were advised along with usual care recommendation.
Usual CareOther
Usual care recommended by National Health Services, self isolation, plenty fluid, rest and Paracetamol. During the Covid 19 outbreak, additional recommendation were followed given by health services.
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda Care Group | Experimental | Individualised ayurveda treatment was given to participants based on individual constitution. Receives: Dietary Supplement: Ayurveda; Other: Usual Care |
| Usual Care Group | Active comparator | Participants followed the usual care. Receives: Other: Usual Care |
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: Change from baseline to 3rd and 7th-day
Severity of symptom score
Symptoms diary card completed twice daily from Day 0 to Day 7
Measured: Change from baseline to 3rd and 7th day
Secondary outcomes (1)
Patient reported improvement
Patient reported improvement using 4 scale; 0-none, 1-weak, 2-medium, 3-strong
Measured: Change from baseline to 3rd and 7th-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start6 Mar 2020
- Primary completion6 Apr 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flu Like IllnessStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Principal investigator, Aarogyam UKJaydeep Joshi, BAMS, Study director, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351542
- Sponsor's protocol ID
- AU09
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ayurveda for Flu-like Illness During the Covid 19 Outbreak: Non Randomised Single-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04351542
- Acronym / sponsor ID
- AU09
- Conditions
- Flu Like Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 6 Apr 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 17 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.
This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurveda Care Group | Experimental | Dietary Supplement: Ayurveda, Other: Usual CareIndividualised ayurveda treatment was given to participants based on individual constitution. |
| Usual Care Group | Active comparator | Other: Usual CareParticipants followed the usual care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with fu like symptoms within 48 hours of onset during March2020
- Mild to moderate symptoms who were advised to self isolate at home for 7-14 days
- 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 (4 listed)
- Pregnant/lactating
- Severe symptoms of respiratory distress patients deemed to require intensive care immediately
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 |
|---|---|---|
| AyurvedaBased on individual constitution (ayurveda based assessment) and symptoms an individual has, ayurveda herbal supplement and self managed practices were advised along with usual care recommendation. | Dietary supplement | Ayurveda Care Group |
| Usual CareUsual care recommended by National Health Services, self isolation, plenty fluid, rest and Paracetamol. During the Covid 19 outbreak, additional recommendation were followed given by health services. | Other | Ayurveda Care Group, Usual Care Group |
Primary outcome
Time to achieve afebrile
Time frame: Change from baseline to 3rd and 7th-day
Time to bring down a fever (oral temperature < 37.2 ̊C)
Severity of symptom score
Time frame: Change from baseline to 3rd and 7th day
Symptoms diary card completed twice daily from Day 0 to Day 7
1 secondary outcome
Patient reported improvement
Time frame: Change from baseline to 3rd and 7th-day
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 17 Apr 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, PhD principal investigator
Aarogyam UK
Jaydeep Joshi, BAMS 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 Ayurveda in people with 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 4 inclusion and 4 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 17 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: Change from baseline to 3rd and 7th-day). 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 17 Apr 2020.