nani formulations for prevention of COVID-19 infectio
- Registration Number
- CTRI/2020/08/027222
- Lead Sponsor
- Hamdard Laboratories India Medicine Division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects who have got direct or indirect exposure to RT-PCR positive COVID-19 patient(s) in last 7 days and whose test is negative for COVID-19.
The following high risk subjects will be included in the study;
a.Touched body fluids of the patient.
b.Had direct physical contact with the body of the patient including physical examination without PPE.
c.Touched or cleaned the linens, clothes, or dishes of the patient.
d.Lives in the same household as the patient.
e.Anyone in close proximity (within 1 meter) of the confirmed case without precautions.
f.Passenger in close proximity of a symptomatic patients in a conveyance.
2.Subjects without any co-morbidities of either sex aged 18-65.
3. Agrees not to self-medicate or not to take the prescribed medication with chloroquine, hydroxychloroquine or other potential antivirals/other drug.
4. Willingness to give informed consent.
1.COVID-19 positive patients.
2.Atopic patients or persons with known allergy to herbal products
3.Critically ill patients.
4.Previously diagnosed with COVID-19
5.Subjects on other prophylactic medications.
6.Immune compromised patients
7.Pregnant and lactating women.
8.Patients bellow 18 and above 65 years
9.Patient taking any other herbal medicine or immune-modulatory drugs
10.Out station patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Rate of COVID-19 positive conversionTimepoint: 14 days
- Secondary Outcome Measures
Name Time Method 1. Levels of Th1 and Th2 cytokines (interferon-Y and interleukin-4) during both pre and post intervention period. <br/ ><br>2. Inflammation response (serum marker; hsCRP) <br/ ><br>3. Hospitalization/ Intensive care unit admission for COVID-19 infection who had turned to COVID-19 positive after enrollment in the study.Timepoint: 14 days