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To Study effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19

Phase 3
Completed
Registration Number
CTRI/2020/05/025254
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30931
Inclusion Criteria

1. Individuals of either sex above 18 and below 68 years

2. Population as described in High/Moderate/Low Risk

3. Individuals who are from the identified containment zone/ quarantine facility with at least 1 confirmed COVID-19 positive case.

4. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study

Exclusion Criteria

1. Persons with severe primary respiratory disease or related complications that may be identified with COVID-19

2. Laboratory confirmed COVID-19 with or without symptoms

3. Pregnant and lactating mothers and those who have a pregnancy plan.

4. Persons with serious critical illness, or severe mental illnesses

5. Individuals with uncontrolled, unstable comorbidities

6. Immunocompromised individuals or those on immunosuppressants and steroids

7. Subjects having a past history of allergy to any medicine that is part of the Unani intervention.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of COVID-19 cases in control as well in interventional group <br/ ><br>2.Improvement in immune status using Immune Status Questionnaire (ISQ) <br/ ><br>Timepoint: 20days
Secondary Outcome Measures
NameTimeMethod
ILTimepoint: NI
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