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Safety and efficacy of Ayurvedic Capsule in mild to moderate COVID-19 infection.

Not Applicable
Completed
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Registration Number
CTRI/2020/07/026570
Lead Sponsor
AMAI Charitable Trust Pune
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
72
Inclusion Criteria

1.Age > 18 years

2.All sexes

3.Case definitions for inclusion in the study will include mild to moderately severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020.

Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI); Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). OR

4.Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of more than 10 days duration OR

5.Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air, where no alternative explanation for respiratory symptoms can be given

Exclusion Criteria

1.Pregnant or lactating women

2.Symptoms of acute respiratory tract infection for more than seven days

3.More than 48 hours have elapsed between meeting inclusion criteria and enrolment

4.Subject is also a participant of any other clinical trial

5.Serious / long-standing co-morbid conditions

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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