Ayurveda as Prophylaxis for Suspected COVID-19 Patients
Primary Purpose
Covid-19
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ayurveda
Sponsored by
About this trial
This is an interventional prevention trial for Covid-19 focused on measuring Ayurveda
Eligibility Criteria
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
Sites / Locations
- British Ayurvedic Medical Council
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Ayurveda
Arm Description
Participants randomised into the control group receive conventional standard care given by recommended guideline.
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.
Outcomes
Primary Outcome Measures
Clinical confirmation of Covid-19
Number of participants with symptomatic, lab-confirmed COVID-19
Secondary Outcome Measures
Full Information
NCT ID
NCT04395976
First Posted
May 19, 2020
Last Updated
February 26, 2021
Sponsor
British Ayurvedic Medical Council
Collaborators
All Party Parliamentary Group - Indian Traditional Sciences, University of Warwick
1. Study Identification
Unique Protocol Identification Number
NCT04395976
Brief Title
Ayurveda as Prophylaxis for Suspected COVID-19 Patients
Official Title
Effect of Ayurveda as Prophylaxis for Suspected Covid-19 Patients: Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Ethical approval was denied
Study Start Date
May 10, 2020 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Ayurvedic Medical Council
Collaborators
All Party Parliamentary Group - Indian Traditional Sciences, University of Warwick
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
Keywords
Ayurveda
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants randomised into the control group receive conventional standard care given by recommended guideline.
Arm Title
Ayurveda
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ayurveda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical confirmation of Covid-19
Description
Number of participants with symptomatic, lab-confirmed COVID-19
Time Frame
From date of enrolment to 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishwes Kulkarni
Organizational Affiliation
University of Warwick
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amarjeet S Bhamra
Organizational Affiliation
All Party Parliamentary Group - Indian Traditional Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neha Sharma
Organizational Affiliation
British Ayurvedic Medical Council
Official's Role
Study Director
Facility Information:
Facility Name
British Ayurvedic Medical Council
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Ayurveda as Prophylaxis for Suspected COVID-19 Patients
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