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
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring Ayurveda, Shanshamani Vati Plus
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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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