Ayurveda for Flu Like Illness During Covid-19 Outbreak

April 15, 2020 updated by: Aarogyam UK

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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

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:

  • 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

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
  • Severe symptoms of respiratory distress patients deemed to require intensive care immediately

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ayurveda Care Group
Individualised ayurveda treatment was given to participants based on individual constitution.
Dietary supplement: Ayurveda
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.
Other: Usual Care
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.
Active Comparator: Usual Care Group
Participants followed the usual care.
Other: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to 3rd and 7th-day
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
Change from baseline to 3rd and 7th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported improvement
Time Frame: Change from baseline to 3rd and 7th-day
Patient reported improvement using 4 scale; 0-none, 1-weak, 2-medium, 3-strong
Change from baseline to 3rd and 7th-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

March 6, 2020

Primary Completion (Actual)

April 6, 2020

Study Completion (Actual)

April 12, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AU09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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