- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345549
Ayurveda Self-Management for Flu Like Symptoms During the Covid-19 Outbreak
April 10, 2020 updated by: Aarogyam UK
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leicester, United Kingdom
- Aarogyam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ayurveda
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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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From Baseline to 3rd and 7th-days of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of influenza symptom score
Time Frame: Twice daily from Day 1 to Day 7
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Symptoms diary card completed twice daily from Day 0 to Day 7
|
Twice daily from Day 1 to Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neha Sharma, Aarogyam UK
- Study Director: Jaydeep Joshi, Aarogyam UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2020
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
April 10, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2020
Last Update Submitted That Met QC Criteria
April 10, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- AU08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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