Effectiveness and safety analysis of SanHanHuaShi granules for the treatment of coronavirus disease 2019: Study protocol and statistical analysis plan for a randomized, parallel-controlled, open-label clinical trial
Liu Y, Chen X, Wang H, Yao C, Gou X, Gao Z, Sun L, Liu D, Tang C, Wei Y, Ding Q, Yang H, Lin J, Chen K, Chen J, Zhao L, Li M, Han L, Wang J, Ren J, Zhang Y · Frontiers in Pharmacology · 2022 August 16
DOI 10.3389/fphar.2022.936925
Objective
Coronavirus disease 2019 (COVID-19) was declared a global pandemic in March 2020 by the World Health Organization (WHO). As of July 2, 2022, COVID-19 has caused more than 545 million infections and 6.3 million deaths worldwide, posing a significant threat to human health. SanHanHuaShi (SHHS) granules, a Chinese herbal medicine, has been included in Protocol for the Diagnosis and Treatment of Novel Coronavirus Disease 2019 (6th to 9th editions) issued by the National Health Commission of China and used to prevent and treat COVID-19 disease. However, there is an absence of high-quality randomized controlled clinical studies to confirm the clinical effectiveness of SHHS. Therefore, a clinical study protocol and a statistical analysis plan were designed to investigate the efficacy and safety of SHHS for the prevention and treatment of COVID-19.
