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CLINICAL TRIAL article
Front. Med.
Sec. Infectious Diseases: Pathogenesis and Therapy
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1531370
Efficacy of Kegan Liyan oral liquid versus Lianhuaqingwen capsules for patients with mild COVID-19: A double-blinded, randomized, controlled, non-inferiority trial
Provisionally accepted
Yuewei Li 1
Yihe Chi 1
Mengting Zhu 1* Feiting Fan 2* Zhongyang Deng 3* Jingmin Xiao 2* Shaohan Jin 2* Luoqi Lin 1* Xiaochun Chen 1* Ruhong Xu 3* Long Fan 2* Xuhua Yu 2* Ziyao Liang 2* Jingyu Quan 2* Shangzhao Li 1* Xinying Peng 3*
Yuanbin Chen 2*
Lin Lin 2* Lei Wu 2*- 1 College of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China
- 2 Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
- 3 Dongguan Ninth People's Hospital, Dongguan, China
Backgroud: Traditional Chinese medicine has been used for Coronavirus disease 2019 (COVID-19) as a therapeutic option. Lianhuaqingwen capsules (LHQW) are well-recognized for their efficacy, while Kegan Liyan oral liquid (KGLY), widely used for influenza treatment, has emerged as a promising candidate for COVID-19 therapy. This trial aims to assess whether KGLY is non-inferior to LHQW in treating mild COVID-19.Method: A total of 127 participants (63 in KGLY group and 64 in LHQW group) were randomly allocated to receive either KGLY therapy or LHQW therapy in a 1:1 ratio. The treatment was given for 7 days, and the follow-up period was 3 days.Outcome measures: The primary outcome was symptom remission at day 10. Secondary outcomes included symptom recovery, time to symptom remission, recovery rates and time to recovery of selected symptoms, change in visual analogue scale score for selected symptoms, area under the curve of the visual analogue scale score for sore throat, negative conversion of the SARS-CoV-2 infection, having a positive test result after negative conversion, and incidence of pneumonia.Results: Full analysis set analysis showed that the symptom remission rate at day 10 was 60.7% with KGLY and 58.3% in LHQW (difference +2.3 p.p., lower limit of 95% confidence interval -14.8 p.p.), indicating non-inferiority. There were no significant differences between the groups for any secondary outcome. The occurrence of adverse events did not differ between the groups and no severe adverse events were documented in either group.Based on the study results, this trial proved that KGLY was non-inferior to LHQW for mild COVID-19, providing a promising option for COVID-19 treatment.
Keywords: coronavirus disease 2019, Kegan Liyan oral liquid, Lianhuaqingwen capsules, non-inferiority, randomized controlled trial
Received: 20 Nov 2024; Accepted: 14 Feb 2025.
Copyright: © 2025 Li, Chi, Zhu, Fan, Deng, Xiao, Jin, Lin, Chen, Xu, Fan, Yu, Liang, Quan, Li, Peng, Chen, Lin and Wu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Mengting Zhu, College of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China
Feiting Fan, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Zhongyang Deng, Dongguan Ninth People's Hospital, Dongguan, China
Jingmin Xiao, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Shaohan Jin, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Luoqi Lin, College of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China
Xiaochun Chen, College of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China
Ruhong Xu, Dongguan Ninth People's Hospital, Dongguan, China
Long Fan, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Xuhua Yu, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Ziyao Liang, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Jingyu Quan, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Shangzhao Li, College of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China
Xinying Peng, Dongguan Ninth People's Hospital, Dongguan, China
Yuanbin Chen, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Lin Lin, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
Lei Wu, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China
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