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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Ayurveda

• Registration Number: NCT04716647
• Lead Sponsor: Aarogyam UK

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-09
• Primary Completion: 2020-12-12
• Study Completion: 2020-12-18
• Status Verified: 2021-01
• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ayurveda Intervention	Ayurveda	Ashwagandha, Giloy and Tulsi were given in tablet form for oral administration.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome	Up to 14-days	Clinical Outcome was recorded on 7-pont ordinal scale of COVID-19

Trial Locations

Locations (1)

Aarogyam UK; 🇬🇧 Leicester, Leicestershire, United Kingdom