A randomized clinical study to evaluate the efficacy and safety of OUTBREAK in mild and moderate COVID19 positive patients

Abstract

To evaluate the efficacy and safety of synthesized drug OUTBREAK, an Ayurvedic formulation for fever of viral origin in mild and moderate COVID19 positive patients. This is the prospective, randomized, multicentre, open label, parallel group interventional clinical endpoint study. Patients coming for the general outpatient department, were screened for viral fever by using the hematological, Biochemical and microbiological antibody assays. One Hundred patients who satisfied the selection criteria were enrolled in the study. Participants were randomized into 2 groups with 50 patients in each group. Patients were given standard treatment. In addition, Tab. OUTBREAK of Bageo Pharmaceuticals Pvt. Ltd., was administered to test groups. There is a highly significant improvement (P<0.001) in the subjects temperature, fever score, headache and SpO2 suggesting a good Analgesic and antipyretic activity of OUTBREAK. There is asignificant improvement in platelet count in the OUTBREAK treated group (P<0.01) when compared to the control group, proving its efficacy intreating thrombocytopenia. The improvement (P<0.01) in the random Sugar level in the OUTBREAK treated group depicts the anti-diabetic property of OUTBREAK.The improvement (P<0.01) in the WBC count in the OUTBREAK treated group depicts the antiviral property of OUTBREAK. The overall quality of life was better in OUTBREAK treated group compared to the control group. There were no serious adverse events reported. OUTBREAK is safe and efficacious in reversing thrombocytopenia and thus normalizing the platelet counts and relieving the clinical signs and symptoms (fever, headache and SpO2) of viral fever associated with thrombocytopenia and other cases of viral fever without thrombocytopenia. OUTBREAK is having good anti-viral, anti-pyretic and immuno-modulatory property.