Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jun;11(6):987-1000.
doi: 10.21037/tp-22-201.

Efficacy and safety of Qinxiang Qingjie oral solution for the treatment of influenza in children: a randomized, double-blind, multicenter clinical trial

Siyuan Hu  1   2 , Rong Ma  1 , Kunling Shen  3   4 , Deli Xin  5 , Xinmin Li  1 , Baoping Xu  3 , Xiaobing Zhao  6 , Ziwei Feng  7 , Yongbin Yan  8 , Zheng Xue  9 , Baoqing Zhang  10 , Xueming Li  11 , Yanmei Zheng  12 , Hongxia Zhou  13 , Liqun Wu  14 , Lili Yang  15 , Hua Xu  16 , Rongchang Shao  17 , Yong Yin  18 , Chengliang Zhong  1   2 , Han Li  2 , Qiuhan Cai  2 , Yaqian Xu  2
Affiliations

Efficacy and safety of Qinxiang Qingjie oral solution for the treatment of influenza in children: a randomized, double-blind, multicenter clinical trial

Siyuan Hu et al. Transl Pediatr. 2022 Jun.

Abstract

Background: Qinxiang Qingjie (QXQJ), an oral solution containing various Chinese herbs, is indicated for pediatric upper respiratory tract infections. The treatment of influenza also shows potential advantages in shortening the duration of illness and improving symptoms. However, there is still a lack of high-quality clinical evidence to support this. The trial was to explore the efficacy and safety of QXQJ for treating pediatric influenza and provide an evidence-based basis for expanding its applicability.

Methods: A randomized, double-blind, double-dummy, positive-controlled, multicenter clinical trial was conducted in 14 hospitals in China. Children aged 1-13 years with influenza and "exterior and interior heat syndromes" as defined by traditional Chinese medicine (TCM) were randomly assigned to two groups with 1:1 radio. Children in the test group received QXQJ oral solution and oseltamivir simulant, while the control group received oseltamivir phosphate granules and QXQJ simulant. The duration of treatment was five days, followed by a two-day follow-up period. The primary endpoint was the clinical recovery time. Secondary endpoints included the time to defervescence, incidences of complications and severe or critical influenza, negative conversion rate, improvement of TCM syndromes, and safety profiles of the therapeutics, which mainly contained the adverse clinical events and adverse drug reactions.

Results: A total of 231 children were randomized to either the QXQJ (n=117) or oseltamivir (n=114) group. The FAS and PPS results showed that both groups experienced a median clinical recovery time of three days (P>0.05). The median time to defervescence of both groups were 36 hours in FAS and PPS (P>0.05), and two groups did not differ in terms of the other secondary endpoints (P>0.05). 14 patients (12.39%) in the QXQJ group and 14 patients (12.50%) in the oseltamivir group reported at least one adverse event, respectively. One serious adverse event occurred in the QXQJ group. There was no significant difference in the incidence of adverse events or adverse drug reactions between the groups.

Conclusions: The efficacy of QXQJ oral solution was comparable to that of oseltamivir for treating influenza in children, with an acceptable safety profile.

Trial registration: Chinese Clinical Trial Registry ChiCTR1900021060.

Keywords: Qinxiang Qingjie oral solution; children; influenza; randomized controlled trial; traditional Chinese herbs.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tp.amegroups.com/article/view/10.21037/tp-22-201/coif). All authors report that this study was funded by Guangzhou ApicHope Pharmaceutical Co., Ltd. The authors have no other conflicts of interest to declare.

Figures

Figure 1
Figure 1
The CONSORT flowchart. CONSORT, Consolidated Standards of Reporting Trials; QXQJ, Qinxiang Qingjie; FAS, full analysis set; PPS, per protocol set; SS, safety set.
Figure 2
Figure 2
The clinical recovery time (days) in the two groups according to the following analyses: (A) FAS, (B) PPS, (C) FAS of the influenza A virus subgroup, (D) PPS of the influenza A virus subgroup, (E) FAS of the influenza B virus subgroup, and (F) PPS of the influenza B virus subgroup. FAS, full analysis set; PPS, per protocol set.
Figure 3
Figure 3
The time (hours) to defervescence in the two groups according to the (A) FAS and (B) PPS analyses. FAS, full analysis set; PPS, per protocol set.
See this image and copyright information in PMC

References

    1. National Clinical Research Center for Respiratory Disease, Chinese Pediatric Society, Chinese Medical Association . Expert consensus on diagnosis and treatment of influenza in children (2020 Edition). Chin J Appl Clin Pediatr 2020;35:1281-8.
    1. National Health Commission of the People’s Republic of China [Internet]. Guidelines for Diagnosis and Treatment of Influenza 2020. [cited 2021 July 1]. Available online: http://www.gov.cn/zhengce/zhengceku/2020-11/05/content_5557639.htm
    1. Monto AS, Koopman JS, Longini IM, Jr. Tecumseh study of illness. XIII. Influenza infection and disease, 1976-1981. Am J Epidemiol 1985;121:811-22. 10.1093/oxfordjournals.aje.a114052 - DOI - PubMed
    1. Fraaij PL, Heikkinen T. Seasonal influenza: the burden of disease in children. Vaccine 2011;29:7524-8. 10.1016/j.vaccine.2011.08.010 - DOI - PubMed
    1. Cowling BJ, Perera RA, Fang VJ, et al. Incidence of influenza virus infections in children in Hong Kong in a 3-year randomized placebo-controlled vaccine study, 2009-2012. Clin Infect Dis 2014;59:517-24. 10.1093/cid/ciu356 - DOI - PubMed