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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ayurveda
Sponsored by
Aarogyam UK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring Ayurveda Intervention, Community Based Participatory Research

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarogyam UK

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ayurveda Intervention

Arm Description

Ashwagandha, Giloy and Tulsi were given in tablet form for oral administration.

Outcomes

Primary Outcome Measures

Time to clinical recovery
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
To evaluate the therapeutic efficacy, promotion of patients were recorded through AiM Covid application

Secondary Outcome Measures

Clinical Outcome
Clinical Outcome was recorded on 7-pont ordinal scale of COVID-19

Full Information

First Posted
January 18, 2021
Last Updated
January 19, 2021
Sponsor
Aarogyam UK
Collaborators
University of Warwick, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
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1. Study Identification

Unique Protocol Identification Number
NCT04716647
Brief Title
Feasibility of Ayurveda in Patients With Mild-to-Moderate COVID-19: A Community-Based Participatory Research
Official Title
A Community-Based Participatory Research to Assess the Feasibility of Ayurveda Intervention in Patients With Mild-to-Moderate COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarogyam UK
Collaborators
University of Warwick, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Ayurveda Intervention, Community Based Participatory Research

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Community Based Participatory Research
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ayurveda Intervention
Arm Type
Experimental
Arm Description
Ashwagandha, Giloy and Tulsi were given in tablet form for oral administration.
Intervention Type
Other
Intervention Name(s)
Ayurveda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to clinical recovery
Description
To evaluate the therapeutic efficacy, mean days for clinical recovery were recorded from AiM Covid Application
Time Frame
Up to 14-days
Title
Proportion of patient with negative conversion in nasopharyngeal swab
Description
To evaluate the therapeutic efficacy, promotion of patients were recorded through AiM Covid application
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Clinical Outcome
Description
Clinical Outcome was recorded on 7-pont ordinal scale of COVID-19
Time Frame
Up to 14-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
Aarogyam UK
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dipa Modi
Organizational Affiliation
East Park Medical Centre, NHS trust, Leicester
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vishwesh Kulkarni
Organizational Affiliation
University of Warwick
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abhimanyu Kumar
Organizational Affiliation
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
Official's Role
Study Director
Facility Information:
Facility Name
Aarogyam UK
City
Leicester
State/Province
Leicestershire
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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