Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Shirashadi Kasai: Shirashadi Kasai (SK). It consists of 5 medicinal plants, namely Albizzia lebbeck, Solanum Xanthocarpum,
Adhatodavasica, Glycyrrhiza glabra and Cinnamum tamal.
10 gm
Sponsors
Prof Jaya Chakravarty
Dr Abhishek Pandey
Prof Yamini Bhusan Tripathi
Vaidya Sushil K Dubey
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 2. Understands and agrees to comply with planned study procedures. 3. Agrees to the collection of OP swabs and venous blood per protocol. 4. Male or non-pregnant female adult >=18 years of age at time of enrolment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen 6. Illness of any duration, and at least one of the following: Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 Requiring mechanical ventilation and/or supplemental oxygen. 7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
Exclusion criteria
Exclusion criteria: 1. ALT/AST > 5 times the upper limit of normal. 2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR 3. Pregnancy or breast feeding. 4. Anticipated transfer to another hospital which is not a study site within 72 hours. 5. Allergy to any study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In this study, Primary outcome will be the time to clinical improvement,defined as the time from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever came first.Timepoint: Daily until discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Other clinical outcomes Virologic outcomes Safety outcomesTimepoint: Other clinical outcomes and Safety outcomes-Daily until hospital discharge, Virologic outcomes-Day 3, 5, 8, 11 (all ± 1 day) if hospitalized | — |
Countries
India
Contacts
Public ContactDr Abhishek Pandey
Institute of Medical Sciences, Banaras Hindu University
Outcome results
None listed