Ayurveda as Prophylaxis for Suspected COVID-19 Patients

NCT04395976 | Withdrawn DMC

• 1 other identifier: BAMC01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19

Keywords

Ayurveda

Outcome Measures

Primary Outcomes (1)

• Clinical confirmation of Covid-19

  Number of participants with symptomatic, lab-confirmed COVID-19

  From date of enrolment to 14 days

Study Arms (2)

Control Group

NO INTERVENTION

Participants randomised into the control group receive conventional standard care given by recommended guideline.

Ayurveda

EXPERIMENTAL

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

Interventions

Ayurveda OTHER

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.

Ayurveda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• British Ayurvedic Medical Council: lead
• All Party Parliamentary Group - Indian Traditional Sciences: collaborator
• University of Warwick: collaborator

Study Sites (1)

British Ayurvedic Medical Council

London, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Medicine, Ayurvedic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Vishwes Kulkarni

  University of Warwick

  PRINCIPAL INVESTIGATOR

• Amarjeet S Bhamra

  All Party Parliamentary Group - Indian Traditional Sciences

  STUDY CHAIR

• Neha Sharma

  British Ayurvedic Medical Council

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 20, 2020
• Study Start: May 10, 2020
• Primary Completion: June 10, 2020
• Study Completion: September 1, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-02

Locations

GB (1)