Feasibility of Ayurveda in Patients With Mild-to-Moderate COVID-19: A Community-Based Participatory Research

Study Overview
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Brief Summary
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Innovative strategies are required to manage COVID-19 in the communities. Back to Roots community based project was a collaborative, pilot intervention program in British Asian community to assess the efficacy and safety of Ayurveda intervention in relieving symptoms of mild-to-moderate COVID-19.

Official Title
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A Community-Based Participatory Research to Assess the Feasibility of Ayurveda Intervention in Patients With Mild-to-Moderate COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Other: Ayurveda


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR), With mild or moderate manifestations of COVID-19 Willing to participate, and consent by signing the informed consent and not involved in another clinical trial during the study Exclusion Criteria: Patients suffering from severe COVID-19 Disease as per World Health Organisation criteria (REF) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit Patients with ongoing immunosuppressive therapy for any reasons Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. Pregnancy and lactation Ayurveda practitioner decision that involvement in the study is not in the patient's best interest

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Interventional Model Description: Community Based Participatory Research
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ayurveda Intervention<br>Ashwagandha, Giloy and Tulsi were given in tablet form for oral administration. | Other: Ayurveda<br>* Dosage was used in common range (Ashwagandha: Doses range from 250 mg to 5 g; Giloy: range from 500mg to 1g; Tulsi: 500mg-1g) Dosage were altered based on age, weight and severity of symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical recovery | To evaluate the therapeutic efficacy, mean days for clinical recovery were recorded from AiM Covid Application | Up to 14-days | 
| Proportion of patient with negative conversion in nasopharyngeal swab | To evaluate the therapeutic efficacy, promotion of patients were recorded through AiM Covid application | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | Clinical Outcome was recorded on 7-pont ordinal scale of COVID-19 | Up to 14-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ayurveda Intervention, Community Based Participatory Research