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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Shanshamani Vati Plus

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • Aarogyam (UK) CIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aarogyam UK
• Collaborators: University of Warwick; All India Institute of Ayurveda, Ministry of AYUSH, Government of India
• Investigators: Study Chair: Dipa Modi, East Park Medical Centre, Leicester NHS Trust; Principal Investigator: Tanuja Nesari, All India Institute of Ayurveda, Ministry of AYUSH, Government of India

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2020
• Primary Completion (ACTUAL): October 27, 2020
• Study Completion (ACTUAL): November 3, 2020

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Ayurveda; Shanshamani Vati Plus
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: AU/WU/ 06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No