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NCT Number: NCT04621903

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarogyam (UK) CIC

Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shanshamani Vati Plus

Other

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

Primary outcomes

  1. Time to COVID-19 symptoms relief

    Time frame: Up to 14-days

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

  2. Prevention of severe stage of Covid19

    Time frame: 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 outcomes

  1. Side effect/ adverse events

    Time frame: Up to 14-days

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

  2. COVID-19 severity worsening

    Time frame: Up to 14-days

    Number of participants requiring hospitalisation

  3. Time to negative saliva

    Time frame: Up to 14-days

    Time to positive-to-negative RT-PCR conversion

Sponsors and collaborators

Lead sponsor

Aarogyam UK

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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