Ayurveda for Flu Like Illness During Covid-19 Outbreak

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

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

Conditions
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Flu Like Illness

Intervention / Treatment
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* Dietary Supplement: Ayurveda
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve afebrile | Time to bring down a fever (oral temperature < 37.2 ̊C) | Change from baseline to 3rd and 7th-day | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |