To assess the safety and outcome of herbal medicine in prevention of COVID-19 infection among high risk populatio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/06/025650
- Lead Sponsor
- Ministry of AYUSH Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4500
1. Population as described in High/Moderate/Low Risk
2. Individuals who are from the identified containment zone/ quarantine facility with at least 1 confirmed COVID-19 positive case.
3. 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
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 co-morbidities
6. Immuno-compromised individuals or those on immune-suppressants 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
Name Time Method 1. Incidence of COVID-19 cases in control as well in interventional group <br/ ><br>2. Improvement in immune status using Immune Status Questionnaire (ISQ)Timepoint: 0th Day, 10th Day, 20th Day and 35th Day
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI