Xuanfei Baidu decoction, a Chinese herbal medicine for coronavirus disease 2019 (COVID-19): a randomized clinical trial

Abstract

Objective: To evaluate the efficacy and safety of Xuanfei Baidu decoction for treating coronavirus disease 2019 (COVID-19).
Methods: Patients with COVID-19 were enrolled, and eligible patients were randomly allocated to three groups: group A (Xuanfei Baidu decoction combined with conventional treatment), group B (Ganlu Xiaodu decoction combined with conventional treatment), and group C (conventional treatment only). The duration of treatment was 14 days. The primary outcomes were the duration of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid testing from positive to negative and hospitalization days. The secondary outcome was the rate of symptom resolution. The safety outcome was drug-related adverse events.
Results: In total, 103 patients with ordinary-type COVID-19 were included and randomly allocated to groups A (34 cases), B (35 cases), and C (34 cases). Duration for SARS-CoV-2 nucleic acid testing from positive to negative was shortest in group A [(9.88 ± 3.62) days], followed by groups C [(11.20 ± 2.93) days] and B [(12.69 ± 4.11) days]; differences between the three groups were statistically significant (P = 0.010). The number of hospitalization days was the least in group A [(14.00 ± 6.55) days], followed by groups B [(15.40 ± 4.02) days] and C [(16.38 ± 5.73) days], and differences between groups were statistically significant (P = 0.019). There was no statistically significant difference in the rate of symptom resolution between groups (P > 0.05). No deaths or serious adverse events occurred in either of the groups.
Conclusion: Considering the treatment of ordinary-type COVID-19, Xuanfei Baidu decoction can shorten the duration from a positive to negative SARS-CoV-2 nucleic acid test, as well as the duration of hospitalization. Moreover, there were no Xuanfei Baidu decoction-induced adverse reactions.

Keywords

COVID-19 / Ordinary type / Randomized clinical trial / Traditional Chinese medicine / Xuanfei Baidu decoction

Conflicts of Interest statement

The authors declare no conflict of interest.

Funding

This work was supported by the National Natural Science Foundation of China (82004505); the National Key Research and Development Program of the Ministry of Science and Technology of China (2020YFC0841600); and Henan Province Coronavirus Emergency Prevention and Control Special Research (201100310400, 201003050).

Author contributions

Conceptualization was carried out by Min Zhao. Tao Li, Min Zhao, Mingjun Zhu, Shixi Zhang, Jiarong He, He Pan, Mingyi Shao, Zhen Wang, Yu Fu, Ning Li, Long Zhao, Xinyao Jin, Fengwen Yang, and Wentai Pang contributed research methods. Tao Li, Min Zhao, and Wentai Pang wrote the protocol. Participant registration and screening were conducted by Tao Li, Mingjun Zhu, Shixi Zhang, Jiarong He, He Pan and Mingyi Shao. Participant randomization was performed by Zhen Wang, Yu Fu, Ning Li, Long Zhao and Fengwen Yang. Jiarong He, He Pan, Mingyi Shao, Zhen Wang, Yu Fu, Ning Li and Long Zhao carried out the research implementation and data collection. Mingjun Zhu and Shixi Zhang conducted the safety assessment. Data analysis was carried out by Tao Li, Wentai Pang and Xinyao Jin. Tao Li and Wentai Pang wrote the original draft. Min Zhao and Wentai Pang revised the manuscript.

Ethical approval of studies and informed consent

The study protocol was reviewed and approved by the Clinical Trials Ethics Committee of the Hubei Provincial Hospital of Integrative Medicine (2020-003). The study protocol adhered to the Declaration of Helsinki. Informed consent was obtained from all participants.

Acknowledgments

None.

Data availability

The data are not publicly available due to secrecy agreement.

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