Ayurveda for Flu Like Illness During Covid-19 Outbreak

Sponsor

Aarogyam UK (Other)

Overall Status

Completed

CT.gov ID

NCT04351542

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

26.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.

Condition or Disease	Intervention/Treatment	Phase
Flu Like Illness	Dietary Supplement: Ayurveda Other: Usual Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Masking Description:

Ayurveda care provide was blinded

Primary Purpose:

Supportive Care

Official Title:

Ayurveda for Flu-like Illness During the Covid 19 Outbreak: Non Randomised Single-blind Controlled Trial

Actual Study Start Date :

Mar 6, 2020

Actual Primary Completion Date :

Apr 6, 2020

Actual Study Completion Date :

Apr 12, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Time to achieve afebrile [Change from baseline to 3rd and 7th-day]
Time to bring down a fever (oral temperature < 37.2 ̊C)
Severity of symptom score [Change from baseline to 3rd and 7th day]
Symptoms diary card completed twice daily from Day 0 to Day 7

Secondary Outcome Measures

Patient reported improvement [Change from baseline to 3rd and 7th-day]
Patient reported improvement using 4 scale; 0-none, 1-weak, 2-medium, 3-strong

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarogyam	Leicester		United Kingdom

Sponsors and Collaborators

Aarogyam UK

Investigators

Principal Investigator: Neha Sharma, PhD, Aarogyam UK
Study Director: Jaydeep Joshi, BAMS, Aarogyam UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aarogyam UK

ClinicalTrials.gov Identifier:

NCT04351542

Other Study ID Numbers:

AU09

First Posted:

Apr 17, 2020

Last Update Posted:

Apr 17, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 17, 2020