NCT04621903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

19 days

First QC Date

November 6, 2020

Last Update Submit

November 18, 2020

Conditions

Covid19

Keywords

AyurvedaShanshamani Vati Plus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Side effect/ adverse events

    Up to 14-days

  • COVID-19 severity worsening

    Up to 14-days

  • Time to negative saliva

    Up to 14-days

Study Arms (1)

Ayurveda

EXPERIMENTAL
Other: Shanshamani Vati Plus

Interventions

Shanshamani Vati PlusOTHER

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

Ayurveda

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarogyam (UK) CIC

Leicester, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Vishwesh Kulkarni

    University of Warwick

    PRINCIPAL INVESTIGATOR

  • Neha Sharma

    Aarogyam UK

    STUDY DIRECTOR

  • Dipa Modi

    East Park Medical Centre, Leicester NHS Trust

    STUDY CHAIR

  • Tanuja Nesari

    All India Institute of Ayurveda, Ministry of AYUSH, Government of India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 9, 2020

Study Start

October 8, 2020

Primary Completion

October 27, 2020

Study Completion

November 3, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Locations

GB(1)