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A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19

Primary Purpose

Covid19

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Shanshamani Vati Plus

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring Ayurveda, Shanshamani Vati Plus

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 period

Exclusion Criteria:

Patients suffering from severe COVID-19 Disease as judged by WHO 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 for example solid organ transplantation, autoimmune diseases or cancer.
Patients with known long term infection like HIV
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

Sites / Locations

Aarogyam (UK) CIC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ayurveda

Arm Description

Outcomes

Primary Outcome Measures

Time to COVID-19 symptoms relief

Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale

Prevention of severe stage of Covid19

Deterioration in clinical status from mild/moderate to severe/critical during the study period assessed by AiM COVID-19 App

Secondary Outcome Measures

Side effect/ adverse events

Number of participants with intervention-related side effect/ adverse events as assessed by AiM COVID-19 App

COVID-19 severity worsening

Number of participants requiring hospitalisation

Time to negative saliva

Time to positive-to-negative RT-PCR conversion

Full Information

NCT ID

NCT04621903

First Posted

November 6, 2020

Last Updated

November 18, 2020

Sponsor

Aarogyam UK

Collaborators

University of Warwick, All India Institute of Ayurveda, Ministry of AYUSH, Government of India

1. Study Identification

Unique Protocol Identification Number

NCT04621903

Brief Title

A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19

Official Title

A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19: Community Based Participatory Research

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 8, 2020 (Actual)

Primary Completion Date

October 27, 2020 (Actual)

Study Completion Date

November 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aarogyam UK

Collaborators

University of Warwick, All India Institute of Ayurveda, Ministry of AYUSH, Government of India

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach. CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Ayurveda, Shanshamani Vati Plus

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ayurveda

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Shanshamani Vati Plus

Intervention Description

Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.

Primary Outcome Measure Information:

Title

Time to COVID-19 symptoms relief

Description

Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale

Time Frame

Up to 14-days

Title

Prevention of severe stage of Covid19

Description

Deterioration in clinical status from mild/moderate to severe/critical during the study period assessed by AiM COVID-19 App

Time Frame

Up to 14-days

Secondary Outcome Measure Information:

Title

Side effect/ adverse events

Description

Number of participants with intervention-related side effect/ adverse events as assessed by AiM COVID-19 App

Time Frame

Up to 14-days

Title

COVID-19 severity worsening

Description

Number of participants requiring hospitalisation

Time Frame

Up to 14-days

Title

Time to negative saliva

Description

Time to positive-to-negative RT-PCR conversion

Time Frame

Up to 14-days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 period Exclusion Criteria: Patients suffering from severe COVID-19 Disease as judged by WHO 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 for example solid organ transplantation, autoimmune diseases or cancer. Patients with known long term infection like HIV 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vishwesh Kulkarni

Organizational Affiliation

University of Warwick

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neha Sharma

Organizational Affiliation

Aarogyam UK

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dipa Modi

Organizational Affiliation

East Park Medical Centre, Leicester NHS Trust

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tanuja Nesari

Organizational Affiliation

All India Institute of Ayurveda, Ministry of AYUSH, Government of India

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarogyam (UK) CIC

City

Leicester

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19

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