Ayurvedic formulations for the prevention of COVID-19 infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/07/026530
- Lead Sponsor
- SASTRA Deemed University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
i.Males and females between 18 and 70 years of age will be informed of the nature of the study and informed written consent will be obtained
ii.COVID positive patients in the hospitals and home quarantine patients
iii.Laboratory confirmed COVID 19 with or without symptoms but NOT with active illness (ventilator support)
iv.Body weights within 25% of the appropriate weight range
v.Twelve lead ECG without significant abnormalities
i.Persons already treated with any of the study drugs during the last 30 days
ii.Pregnant and lactating females and those who have a pregnancy plan
iii.Known allergy to any of the medications used in this trial
iv.Any disease or condition, which might compromise the haematopoietic, renal, liver, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal system
v.History of allergic conditions â?? asthma, urticaria, eczema
vi.History of autoimmune disorders â?? lupus erythematosis (SLE)
vii.History of alcohol addiction
viii.History or presence of dyspepsia, gastric ulcer or duodenal ulcer
ix.History of psychiatric disorders
x.Presence of clinically significant abnormal laboratory results during screening. Use of any recreational drugs or a history of drug addiction
xi.Subjects with HIV, HBV and HCV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19Timepoint: After enrollment on day one, clinical assessments will be done on day 3, 6, 9 and 12 and 14
- Secondary Outcome Measures
Name Time Method 1) Incidence of severe COVID 19 positive cases among Ayurveda users <br/ ><br>2) Incidence of mortality due to COVID 19 among Ayurveda users. <br/ ><br>3) Incidence of any other ailment like cough, fever, sore throat etc during this study <br/ ><br>4) Requirement of treatment for symptoms developed, if any, during study period <br/ ><br>5) Change in appetite, bowel habit, sleep among the users. <br/ ><br>6) ADR/AE due to use of any particular Ayurveda advocacies <br/ ><br>Timepoint: Time points: After enrollment on day one, clinical assessments will be done on day 3, 6, 9 and 12 and 14