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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621903
• Other study ID #: AU/WU/ 06
• Status: Completed
• Phase: N/A
• Start date: October 8, 2020
• Est. completion date: November 3, 2020

Study information

• Verified date: November 2020
• Source: Aarogyam UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 3, 2020
• Est. primary completion date: October 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Aarogyam (UK) CIC	Leicester

Sponsors (3)

Lead Sponsor	Collaborator
Aarogyam UK	All India Institute of Ayurveda, Ministry of AYUSH, Government of India, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to COVID-19 symptoms relief	Clinical improvement was recorded by AiM COVID-19 App using numeric rating scale	Up to 14-days
Primary	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	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
Secondary	COVID-19 severity worsening	Number of participants requiring hospitalisation	Up to 14-days
Secondary	Time to negative saliva	Time to positive-to-negative RT-PCR conversion	Up to 14-days