Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: As standard treatment suggested by WHO/ICMR (treatment period of 14 days): As standard treatment suggested by WHO/ICMR for Covid-19 patients for a treatment period of 14 days
Control In
Sponsors
SASTRA Deemed University
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) Incidence of severe COVID 19 positive cases among Ayurveda users 2) Incidence of mortality due to COVID 19 among Ayurveda users. 3) Incidence of any other ailment like cough, fever, sore throat etc during this study 4) Requirement of treatment for symptoms developed, if any, during study period 5) Change in appetite, bowel habit, sleep among the users. 6) ADR/AE due to use of any particular Ayurveda advocacies Timepoint: Time points: After enrollment on day one, clinical assessments will be done on day 3, 6, 9 and 12 and 14 | — |
Countries
India
Contacts
Public ContactDr S Swaminathan
Kamakshi Ayurvedha Vaidyasala
Outcome results
None listed