NCT04345549

Brief Summary

From the end of January 2020, Coronavirus disease 2019 began to spread in United Kingdom (UK). During the same time, seasonal flu continued to circulate across the UK. With similar course of management at early stages, flu like symptoms were self-isolated to prevent the spread and further complications of infection. Present study aimed to evaluate the effect of self-managed Ayurveda on flu like symptoms in people who self-isolated at home for 7-days in March 2020 during the Covid-19 outbreak in UK.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 10, 2020

Last Update Submit

April 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to achieve afebrile

    Time to bring down a fever (oral temperature \< 37.2˚C)

    From Baseline to 3rd and 7th-days of intervention

Secondary Outcomes (1)

  • Severity of influenza symptom score

    Twice daily from Day 1 to Day 7

Study Arms (1)

Ayurveda

EXPERIMENTAL

All the participants were advised to self-isolate for 7-days and maintain hygiene and self-care as per recommended guidelines. Along with that, participants were advised to constitution based Ayurveda treatment using herbs, life style and yoga.

Other: Individualised Ayurveda

Interventions

Saline warm water gargle, Steam, Paracetamol for body temperature and plenty fluid and rest, Food and herbs recommendation as per individual Ayurveda constitution, Using Ginger/ lemon/ turmeric/ honey recommended as per individual, Yoga breathing

Ayurveda

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
  • Willing to consent and follow up

You may not qualify if:

  • Pregnant/lactating
  • Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
  • Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarogyam

Leicester, United Kingdom

Location

Study Officials

  • Neha Sharma

    Aarogyam UK

    PRINCIPAL INVESTIGATOR
  • Jaydeep Joshi

    Aarogyam UK

    STUDY DIRECTOR

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

April 10, 2020

First Posted

April 14, 2020

Study Start

February 26, 2020

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations