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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Other: Shanshamani Vati Plus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ayurveda<br> | Other: Shanshamani Vati Plus<br>* Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to COVID-19 symptoms relief | Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale | Up to 14-days | 
| 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 | Up to 14-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect/ adverse events | Number of participants with intervention-related side effect/ adverse events as assessed by AiM COVID-19 App | Up to 14-days | 
| COVID-19 severity worsening | Number of participants requiring hospitalisation | Up to 14-days | 
| Time to negative saliva | Time to positive-to-negative RT-PCR conversion | Up to 14-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ayurveda, Shanshamani Vati Plus