Ayurveda as Prophylaxis for Suspected COVID-19 Patients

February 26, 2021 updated by: British Ayurvedic Medical Council

Effect of Ayurveda as Prophylaxis for Suspected Covid-19 Patients: Randomised Controlled Trial

Despite worldwide efforts to contain, manage and treat Covid-19, the pandemic is continuing to spread. This calls for an urgent clinically-proven prophylaxis and therapeutic strategy. Recent developments on the use of traditional medicines in Covid-19 management has drawn enough attention to start several research studies. Based on the Indian Traditional Medicine, Ayurveda's community initiatives, preliminary studies, and our experiential knowledge on Covid-19 settings, we propose present study to prevent the development of COVID-19 symptoms in people who live or have come contact with an individual diagnosed with COVID-19.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
      • London, United Kingdom
        • British Ayurvedic Medical Council

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Person who has come into contact with confirmed COVID-19,
  • Willing to take study drug as directed

Exclusion Criteria:

  • Confirmed current COVID-19
  • Inability to take medications orally
  • Inability to provide written consent

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Participants randomised into the control group receive conventional standard care given by recommended guideline.
Experimental: Ayurveda
Treatment includes a tailored combination of herbs based on individual constitution (based on Ayurveda) nutritional advice, specific consideration of selected food items, specific lifestyle advice, yoga advice along with standard recommendations.
Other: Ayurveda
The Ayurveda intervention is multimodal and following the principles of Ayurveda as a whole medical system, each participants will be treated with individualised care. From the range of proven Ayurvedic Herbs, combination will be decided based on individual participants, his symptoms and his personality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical confirmation of Covid-19
Time Frame: From date of enrolment to 14 days
Number of participants with symptomatic, lab-confirmed COVID-19
From date of enrolment to 14 days

Collaborators and Investigators

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

Sponsor

British Ayurvedic Medical Council

Collaborators

University of Warwick
All Party Parliamentary Group - Indian Traditional Sciences

Investigators

  • Principal Investigator: Vishwes Kulkarni, University of Warwick
  • Study Chair: Amarjeet S Bhamra, All Party Parliamentary Group - Indian Traditional Sciences
  • Study Director: Neha Sharma, British Ayurvedic Medical Council

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)

May 10, 2020

Primary Completion (Actual)

June 10, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAMC01

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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