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

Not Applicable

Completed

• Conditions: Covid19
• Interventions: Other: Shanshamani Vati Plus

• Registration Number: NCT04621903
• Lead Sponsor: Aarogyam UK

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-08
• Primary Completion: 2020-10-27
• Status Verified: 2020-11
• Study Completion: 2020-11-03
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-09
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ayurveda	Shanshamani Vati Plus	-

Primary Outcome Measures

Name	Time	Method
Time to COVID-19 symptoms relief	Up to 14-days	Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale
Prevention of severe stage of Covid19	Up to 14-days	Deterioration in clinical status from mild/moderate to severe/critical during the study period assessed by AiM COVID-19 App

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarogyam (UK) CIC; 🇬🇧 Leicester, United Kingdom