文献类型：期刊文献

英文题名：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

作者：Liu, Yangyang[1,2];Chen, Xi[2];Wang, Hongan[2];Yao, Chensi[3];Gou, Xiaowen[3];Gao, Zezheng[3];Sun, Linlin[2];Liu, Dan[2];Tang, Cheng[2];Wei, Yu[4];Ding, Qiyou[4];Yang, Haoyu[4];Lin, Jiaran[4];Chen, Keyu[4];Chen, Jia[5];Zhao, Linhua[6];Li, Min[7];Han, Lin[6];Wang, Jian[2];Ren, Jixiang[2];Zhang, Ying[8]

第一作者：Liu, Yangyang

通信作者：Wang, J[1];Ren, JX[1];Zhang, Y[2]

机构：[1]Beijing Univ Chinese Med, Inst Integrated Tradit Chinese & Western Med, Beijing, Peoples R China;[2]Changchun Univ Chinese Med, Affiliated Hosp, Changchun, Peoples R China;[3]Guanganmen Hosp China, Acad Chinese Med Sci, Dept Endocrinol, Beijing, Peoples R China;[4]Beijing Univ Tradit Chinese Med, Grad Coll, Beijing, Peoples R China;[5]Gansu Univ Chinese Med, Lanzhou, Peoples R China;[6]Guanganmen Hosp China, Inst Metab Dis, Acad Chinese Med Sci, Beijing, Peoples R China;[7]Guanganmen Hosp China, Acad Chinese Med Sci, Mol Biol Lab, Beijing, Peoples R China;[8]Beijing Univ Chinese Med, Sch Tradit Chinese Med, Beijing, Peoples R China

第一机构：Beijing Univ Chinese Med, Inst Integrated Tradit Chinese & Western Med, Beijing, Peoples R China

通信机构：[1]corresponding author), Changchun Univ Chinese Med, Affiliated Hosp, Changchun, Peoples R China;[2]corresponding author), Beijing Univ Chinese Med, Sch Tradit Chinese Med, Beijing, Peoples R China.

年份：2022

卷号：13

外文期刊名：FRONTIERS IN PHARMACOLOGY

收录：;Scopus(收录号：2-s2.0-85137735103);WOS:【SCI-EXPANDED(收录号:WOS:000848346300001)】；

基金：This study was funded by the Special Project for Emergency of the Ministry of Science and Technology of PR. China (No. 2022YFC0868300), National Key Research and Development Program of China (No. 2021YFE0201100), and Special Project for Emergency Research on the Prevention and Control of COVID-19 by Traditional Chinese Medicine, supported by National Administration of Traditional Chinese Medicine (2022ZYLCYJ01-4). The funder has no role in the design of the study; collection, analysis, and interpretation of data; writing of the manuscript, or decision to submit the manuscript for publication.

语种：英文

外文关键词：SanHanHuaShi Granules; Traditional Chinese Medicine; COVID-19; effectiveness; protocol; Statistical analysis plan

摘要：Background: 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. Currently, there is still a lack of effective prevention and control strategies for the variation and transmission of SARS-CoV-2. Traditional Chinese medicine (TCM), which has a unique theoretical system, has treated various conditions for thousands of years. Importantly, recent studies have revealed that TCM contributed significantly to COVID-19. SanHanHuaShi (SHHS) granules, a Chinese herbal medicine, which 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. A previous retrospective cohort study showed that SHHS could significantly reduce the severity of mild and moderate COVID-19. 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. This study will increase the integrity and data transparency of the clinical research process, which is of great significance for improving the practical application of SHHS granules in the future. Methods and analysis: The study was designed as a 7-day, randomized, parallel controlled, open-label, noninferiority clinical trial of positive drugs. A total of 240 patients with mild and moderate COVID-19 will be enrolled and randomly assigned to receive SanHanHuaShi granules or LianHuaQingWen granules treatment in a 1:1 ratio. Disease classification, vital signs, SARS-CoV-2 nucleic acid testing, symptoms, medications, adverse events, and safety evaluations will be recorded at each visit. The primary outcome will be the clinical symptom recovery rate. Secondary outcomes will include the recovery time of clinical symptoms, negative conversion time of SARS-CoV-2 nucleic acid test negative conversion rate, hospitalization time, antipyretic time, rate of conversion to severe patients, and time and rate of single symptom recovery. Adverse incidents and safety assessments will be documented. All data will be analyzed using a predetermined statistical analysis plan, including our method for imputation of missing data, primary and secondary outcome analyses, and safety outcomes. Discussion: The results of this study will provide robust evidence to confirm the effectiveness and safety of SHHS in the treatment of COVID-19.