A Trial of Shirashadi Kasai in patients with Covid-19

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: 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 decoction, twice a day, through oral route Control Intervention1: Standard care for COVID 19 patients as per Government of India advisory: Drugs advised by Government of India in its advisory for COVID 19 patients CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: 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 OUTCOME: 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 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 â?Â¥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 < 72 hours prior to randomization. 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 â?¤ 94%on room air, OR Requiring mechanical ventilation and/or supplemental oxygen. 7. Women of childbearing potential must agree to use at least one primar
Epistemonikos ID: a6cf6c6c9c3f73e2714e1984bc23f2c849cc60a1
First added on: Jul 15, 2020