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Chinese Medicine Formula Huashibaidu Granule Early Treatment for Mild COVID-19 Patients: An Unblinded, Cluster-Randomized Clinical Trial.
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.
  • Zhao C; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Li L; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Yang W; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Lv W; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Wang J; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Guo J; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Dong Y; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Shi N; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Lu C; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Li Z; Department of Neurosurgery, Zhongnan Hospital of Wuhan University, Wuhan, China.
  • Shi Z; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Chen R; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Huo R; China Academy of Chinese Medical Sciences, Beijing, China.
  • Che Q; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Tian Y; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Xiang X; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Wang J; Department of Traditional Chinese Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China.
  • Zhou J; Department of Neurosurgery, Zhongnan Hospital of Wuhan University, Wuhan, China.
  • Bian Y; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Chen S; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Chen Y; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Chen Y; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Cong X; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Dong G; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Hu L; China Academy of Chinese Medical Sciences, Beijing, China.
  • Jiang J; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Leng L; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Li B; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Li D; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Li H; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Li J; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Qi W; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Miao Q; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Shi H; China Academy of Chinese Medical Sciences, Beijing, China.
  • Shi J; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Wang B; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Wang G; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Wang W; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Xian Y; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Xie X; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Xu C; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Xu M; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Yan B; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Yang J; Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Zhang L; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Zhou Z; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Zhu H; Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
  • Xiong Y; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Liu B; Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
  • Huang L; China Academy of Chinese Medical Sciences, Beijing, China.
Front Med (Lausanne) ; 8: 696976, 2021.
Article in English | MEDLINE | ID: covidwho-1450816
ABSTRACT

Background:

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.

Methods:

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.

Results:

All 408 participants were followed up to their clinical endpoint and included in statistical analysis. Baseline characteristics were comparable between the two groups (P > 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 (P = 0.014). Eight foreseeable mild adverse events occurred without statistical difference between groups (P = 0.151).

Conclusion:

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. Clinical Trial Registrationwww.chictr.org.cn/showproj.aspx?proj=49408, identifier ChiCTR2000029763.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Controlled clinical trial / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Front Med (Lausanne) Year: 2021 Document Type: Article Affiliation country: Fmed.2021.696976

Full text: Available Collection: International databases Database: MEDLINE Type of study: Controlled clinical trial / Observational study / Prognostic study / Randomized controlled trials Language: English Journal: Front Med (Lausanne) Year: 2021 Document Type: Article Affiliation country: Fmed.2021.696976