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

January 19, 2021 updated by: Aarogyam UK

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom
        • Aarogyam UK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ayurveda Intervention
Ashwagandha, Giloy and Tulsi were given in tablet form for oral administration.
Other: Ayurveda
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarogyam UK

Collaborators

University of Warwick
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Investigators

  • Study Chair: Dipa Modi, East Park Medical Centre, NHS trust, Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2020

Primary Completion (Actual)

December 12, 2020

Study Completion (Actual)

December 18, 2020

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU/2187

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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