A Randomized Open Label Parallel Clinical Study to Evaluate the Safety and Efficacy of Clevira Tablets against Influenza Viruses

Abstract

Objective: The aim of the study was to compare the efficacy of Clevira tablets in Human adult patients, with Influenza A&B and Vital flu. Methods: This study was an open label, balanced, randomized, multi-dose, two-treatment, parallel, and comparative Phase III clinical trial to determine the safety and efficacy of Clevira Tablets. Twenty patients were enrolled and received Clevira Tablet along with Standard Treatment for Influenza A&B and other respiratory viral infections. Enrollment was based on the diagnosis of hematology, biochemistry, serology, RT-PCR, and chest X-ray and inclusion, and none of the exclusion criteria and included in the study. Results: All the patients demonstrated safety measures with respect to blood pressure and pulse rate. Furthermore, statistically significant (P < 0.0001) improvement showed in temperature from baseline (102.03 ± 0.64) and at the end of the study period (98.14 ± 0.70). Conclusion: The study demonstrated an expedited clinical cure with normal vital signs and hematological results which validated that Clevira is safe and efficacious in patients with Influenza A&B and Viral flu. The data further entrusted that Clevira can be used in infected patients with Influeza A&B and Viral Flu, and relieve the signs and symptoms, with a rapid recovery, without any adverse side effects.