AUTHOR=Zhao Chen , Li Li , Yang Wei , Lv Wenliang , Wang Jian , Guo Jing , Dong Yu , Shi Nannan , Lu Cheng , Li Zhiqiang , Shi Zhan , Chen Renbo , Huo Ruili , Che Qianzi , Tian Yaxin , Xiang Xinghua , Wang Jian , Zhou Junhui , Bian Yongjun , Chen Suping , Chen Yang , Chen Yingying , Cong Xiaodong , Dong Guoju , Hu Lijie , Jiang Jianxin , Leng Luxing , Li Bin , Li Dongxu , Li Hao , Li Jing , Qi Wensheng , Miao Qing , Shi Huaxin , Shi Jiaheng , Wang Bing , Wang Gang , Wang Wei , Xian Yongyue , Xie Xiaolei , Xu Chunyan , Xu Ming , Yan Bei , Yang Jinliang , Zhang Li , Zhou Zhenqi , Zhu Haoning , Xiong Yibai , Liu Bin , Huang Luqi 

TITLE=Chinese Medicine Formula Huashibaidu Granule Early Treatment for Mild COVID-19 Patients: An Unblinded, Cluster-Randomized Clinical Trial

JOURNAL=Frontiers in Medicine

VOLUME=8

YEAR=2021

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.696976

DOI=10.3389/fmed.2021.696976

ISSN=2296-858X

ABSTRACT=<p><bold>Background:</bold> Previous research suggested that Chinese Medicine (CM) Formula Huashibaidu granule might shorten the disease course in coronavirus disease 2019 (COVID-19) patients. This research aimed to investigate the early treatment effect of Huashibaidu granule in well-managed patients with mild COVID-19.</p><p><bold>Methods:</bold> An unblinded cluster-randomized clinical trial was conducted at the Dongxihu FangCang hospital. Two cabins were randomly allocated to a CM or control group, with 204 mild COVID-19 participants in each cabin. All participants received conventional treatment over a 7 day period, while the ones in CM group were additionally given Huashibaidu granule 10 g twice daily. Participants were followed up to their clinical endpoint. The primary outcome was worsening symptoms before the clinical endpoint. The secondary outcomes were cure and discharge before the clinical endpoint and alleviation of composite symptoms after the 7 days of treatment.</p><p><bold>Results:</bold> All 408 participants were followed up to their clinical endpoint and included in statistical analysis. Baseline characteristics were comparable between the two groups (<italic>P</italic> &gt; 0.05). The number of worsening patients in the CM group was 5 (2.5%), and that in the control group was 16 (7.8%) with a significant difference between groups (<italic>P</italic> = 0.014). Eight foreseeable mild adverse events occurred without statistical difference between groups (<italic>P</italic> = 0.151).</p><p><bold>Conclusion:</bold> Seven days of early treatment with Huashibaidu granule reduced the likelihood of worsening symptoms in patients with mild COVID-19. Our study supports Huashibaidu granule as an active option for early treatment of mild COVID-19 in similar well-managed medical environments.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="https://www.chictr.org.cn/showproj.aspx?proj=49408" xmlns:xlink="http://www.w3.org/1999/xlink">www.chictr.org.cn/showproj.aspx?proj=49408</ext-link>, identifier: ChiCTR2000029763.</p>