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. 2021 Apr 28;15(5):704–717. doi: 10.1007/s11684-021-0853-6

Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

Li Ni 1,#, Zheng Wen 1,#, Xiaowen Hu 2,#, Wei Tang 3,#, Haisheng Wang 4,#, Ling Zhou 1, Lujin Wu 1, Hong Wang 1, Chang Xu 1, Xizhen Xu 1, Zhichao Xiao 1, Zongzhe Li 1, Chene Li 1, Yujian Liu 1, Jialin Duan 1, Chen Chen 1, Dan Li 1, Runhua Zhang 1, Jinliang Li 5, Yongxiang Yi 6, Wei Huang 1,7, Yanyan Chen 8, Jianping Zhao 9, Jianping Zuo 3,✉, Jianping Weng 2,✉, Hualiang Jiang 3,10,✉, Dao Wen Wang 1,✉
PMCID: PMC8079840  PMID: 33909260

Abstract

We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, P = 0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), −46.39 (−86.83 to −5.94) HU; P = 0.025) and day 14 (mean difference (95% CI), −74.21 (−133.35 to −15.08) HU; P = 0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.

Electronic Supplementary Material

Supplementary material is available for this article at 10.1007/s11684-021-0853-6 and is accessible for authorized users.

Keywords: COVID-19, SARS-CoV-2, Shuanghuanglian oral liquid, clinical trial

Electronic Supplementary Material

11684_2021_853_MOESM1_ESM.pdf (350.7KB, pdf)

Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

Acknowldgements

This work was supported by the National Key R&D Program of China (No. 2020YFC0841400), Tongji Hospital Clinical Research Project (Nos. XXGZBDYJ009 and 2019YBKY019). We thank the patients who participated in this trial. We thank the participants for their involvement in the study, in particular, we want to thank Drs. Liming Xia and Chong Chen of Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Yan Ma of the First Affiliated Hospital of University of Science and Technology of China, for their contributions in this trial. We would like to thank Prof. Jingxin Li of Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China, for her constructive comments and great help in the statistical analysis. We thank Profs. Yechun Xu and Xiaoyan Chen at Shanghai Institute of Materia Medica, Chinese Academy of Sciences for their help in providing information of pharmacokinetic data of Shuanghuanlian and its active components. We thank Sanchine Pharmaceutical Co., Ltd., HPGC, for providing the medicine of Shuanghuanglian oral liquid for this trial. We also thank iFLYTEK for providing AI software to analyze the chest CT imaging data. We thank Prof. H. Eric Xu at Shanghai Institute of Materia Medica, Chinese Academy of Sciences, for his help in writing this paper and his constructive comments. Finally, we want to thank GX Pharma Technology (Beijing) Co. Ltd. for providing the CRO service in the trial for other hospitals except Tongji Hospital.

Footnotes

Compliance with ethics guidelines

Li Ni, Zheng Wen, Xiaowen Hu, Wei Tang, Haisheng Wang, Ling Zhou, Lujin Wu, Hong Wang, Chang Xu, Xizhen Xu, Zhichao Xiao, Zongzhe Li, Chenze Li, Yujian Liu, Jialin Duan, Chen Chen, Dan Li, Runhua Zhang, Jinliang Li, Yongxiang Yi, Wei Huang, Yanyan Chen, Jianping Zhao, Jianping Zuo, Jianping Weng, Hualiang Jiang, and Dao Wen Wang declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Informed consent was obtained from all the patients, in which their identifying information is included in this article. Other ethical board approval is not applicable in this manuscript.

These authors contributed equally to this study.

Contributor Information

Jianping Zuo, Email: jpzuo@simm.ac.cn.

Jianping Weng, Email: wengjp@ustc.edu.cn.

Hualiang Jiang, Email: hljiang@simm.ac.cn.

Dao Wen Wang, Email: dwwang@tjh.tjmu.edu.cn.

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Supplementary Materials

11684_2021_853_MOESM1_ESM.pdf (350.7KB, pdf)

Effects of Shuanghuanglian oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinical trial

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