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OpenTrials
Completed

NCT Number: NCT04716647

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarogyam UK

Leicester, Leicestershire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ayurveda

Other

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 outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Clinical Outcome

    Time frame: Up to 14-days

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

Sponsors and collaborators

Lead sponsor

Aarogyam UK

Other

Collaborators

  • Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
  • University of Warwick

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2021
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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