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Ayurveda Self-Management for Flu Like Symptoms During the Covid-19 Outbreak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04345549
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Aarogyam UK

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Flu Like Symptom Flu Like Illness Other: Individualised Ayurveda Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ayurveda Self-Management for Flu Like Symptoms in People Self-Isolated for 7 Days During the Coronavirus Disease 2019 (COVID-19) Outbreak
Actual Study Start Date : February 26, 2020
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

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.
Other: Individualised Ayurveda
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Severity of influenza symptom score [ Time Frame: Twice daily from Day 1 to Day 7 ]
    Symptoms diary card completed twice daily from Day 0 to Day 7



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345549


Locations
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United Kingdom
Aarogyam
Leicester, United Kingdom
Sponsors and Collaborators
Aarogyam UK
Investigators
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Principal Investigator: Neha Sharma Aarogyam UK
Study Director: Jaydeep Joshi Aarogyam UK
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Responsible Party: Aarogyam UK
ClinicalTrials.gov Identifier: NCT04345549    
Other Study ID Numbers: AU08
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No