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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716647
• Other study ID #: AU/2187
• Status: Completed
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: January 2021
• Source: Aarogyam UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 18, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Ayurveda
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.

Locations

Country	Name	City	State
United Kingdom	Aarogyam UK	Leicester	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
Aarogyam UK	Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical recovery	To evaluate the therapeutic efficacy, mean days for clinical recovery were recorded from AiM Covid Application	Up to 14-days
Primary	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	Clinical Outcome	Clinical Outcome was recorded on 7-pont ordinal scale of COVID-19	Up to 14-days