NCT04716647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 18, 2021

Last Update Submit

January 19, 2021

Conditions

Covid19

Keywords

Ayurveda Intervention, Community Based Participatory Research

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Clinical Outcome

    Up to 14-days

Study Arms (1)

Ayurveda Intervention

EXPERIMENTAL

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

Other: Ayurveda

Interventions

AyurvedaOTHER

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.

Ayurveda Intervention

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarogyam UK

Leicester, Leicestershire, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Medicine, Ayurvedic

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Medicine, TraditionalComplementary TherapiesTherapeutics

Study Officials

  • Neha Sharma

    Aarogyam UK

    STUDY DIRECTOR

  • Dipa Modi

    East Park Medical Centre, NHS trust, Leicester

    STUDY CHAIR

  • Vishwesh Kulkarni

    University of Warwick

    PRINCIPAL INVESTIGATOR

  • Abhimanyu Kumar

    Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Community Based Participatory Research
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 20, 2021

Study Start

October 9, 2020

Primary Completion

December 12, 2020

Study Completion

December 18, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

GB(1)