Ayurveda for Flu Like Illness During Covid-19 Outbreak

Flu Like Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351542
• Other study ID #: AU09
• Status: Completed
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: April 12, 2020

Study information

• Verified date: April 2020
• Source: Aarogyam UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 12, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Flu Like Illness

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Aarogyam	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Aarogyam UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to achieve afebrile	Time to bring down a fever (oral temperature < 37.2 °C)	Change from baseline to 3rd and 7th-day
Primary	Severity of symptom score	Symptoms diary card completed twice daily from Day 0 to Day 7	Change from baseline to 3rd and 7th day
Secondary	Patient reported improvement	Patient reported improvement using 4 scale; 0-none, 1-weak, 2-medium, 3-strong	Change from baseline to 3rd and 7th-day