Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial
BackgroundXiao’er Fengre Qing Oral Liquid (XFQOL) is developed based on the classical traditional Chinese medicinal formula Yinqiao Powder. Compared to the original formulation, XFQOL exhibits enhanced heat-clearing, detoxification, and fever reduction, which can effectively address the common compl...
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2025-05-01
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| author | Shengxuan Guo Xinmin Li Yuejie Zheng Chengliang Zhong Lei Xiong Xi Ming Ying Ding Yongbin Yan Baoqing Zhang Peng Zhou Zhou Fu Jun Wang Xuefeng Wang Junhong Wang Jinghua Yang Yanxia Liu Jianxin Cai Lihua Ning Xiaohong Liu Hang Zhu Linlin Gai Pingding Liu Dahong Sun Taizhong Wang Xiaojiao Li Xinhua Tian Junguang Zhang Wenda Guan Yupin Li Xueming Li Junfeng Liu Nanyue Kuang Ling Lu Tongxun Gao Haodong Liang Kunling Shen Rong Ma |
| author_facet | Shengxuan Guo Xinmin Li Yuejie Zheng Chengliang Zhong Lei Xiong Xi Ming Ying Ding Yongbin Yan Baoqing Zhang Peng Zhou Zhou Fu Jun Wang Xuefeng Wang Junhong Wang Jinghua Yang Yanxia Liu Jianxin Cai Lihua Ning Xiaohong Liu Hang Zhu Linlin Gai Pingding Liu Dahong Sun Taizhong Wang Xiaojiao Li Xinhua Tian Junguang Zhang Wenda Guan Yupin Li Xueming Li Junfeng Liu Nanyue Kuang Ling Lu Tongxun Gao Haodong Liang Kunling Shen Rong Ma |
| author_sort | Shengxuan Guo |
| collection | DOAJ |
| description | BackgroundXiao’er Fengre Qing Oral Liquid (XFQOL) is developed based on the classical traditional Chinese medicinal formula Yinqiao Powder. Compared to the original formulation, XFQOL exhibits enhanced heat-clearing, detoxification, and fever reduction, which can effectively address the common complications associated with influenza in children and is well-suited for pediatric use. However, there is currently a lack of high-quality evidence from clinical trials to support its efficacy and safety in clinical applications.ObjectiveThis study aimed to investigate the efficacy and safety of XFQOL compared with Oseltamivir in pediatric influenza.MethodsA multicenter, block-randomized, double-blind, double-dummy, positive-drug-controlled, non-Inferiority clinical trial design was conducted. The study plans to enroll 420 pediatric participants, with 210 in each group. The experimental group will receive XFQOL with an Oseltamivir granules placebo, and the control group will receive Oseltamivir granules with a XFQOL placebo for 5 days, followed by a 2-day post-treatment observation. The primary endpoint was clinical recovery time, while secondary endpoints included complete fever resolution time, the area under the curve (AUC) of Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom dimension Score over time, Traditional Chinese Medicine (TCM) syndrome efficacy, disappearance rates for individual symptoms, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate. Safety evaluation focused on adverse events (AE) and adverse drug reactions (ADR).ResultsA total of 418 participants were included in the Full Analysis Set, with 208 in the experimental group and 210 in the control group. Baseline characteristics were comparable between the groups. The median time to clinical recovery was 3 days for both groups, with a hazard ratio and its 95% confidence interval (experimental group/control group) of 1.115 (95% CI: 0.912–1.363). Non-inferiority testing demonstrated that the experimental group was not inferior to the control group. Subgroup analyses (positive for RT-PCR influenza, positive for RT-PCR influenza A, positive for RT-PCR influenza B) yielded results consistent with the primary endpoint. The median time to complete fever resolution was 32 h in both groups, with no statistically significant difference (P = 0.407). There were no statistically significant differences in the AUC of CARIFS symptom scores over time between the groups (P = 0.211). No significant differences were observed between the groups in the efficacy rates of TCM syndromes of Wind-Heat Invading the Defense Syndrome (P = 0.076) and Fright-complicated Syndrome (P = 0.168); however, significant differences were found in Phlegm-complicated Syndrome (P = 0.008) and Food-stagnation-complicated Syndrome (P = 0.024). The disappearance rates for individual symptoms, such as red and swollen pharynx, cough, copious sputum or audible phlegm sounds in the throat, and lack of appetite, showed statistically significant differences between the groups (P < 0.05), while no significant differences were observed for other symptoms. No statistically significant differences were observed between the experimental and control groups in the incidence of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate (P > 0.05). The incidence rates of AE (P = 0.885) and ADR (P = 0.685) were comparable between the two groups, with no statistically significant differences observed.ConclusionThe efficacy of XFQOL in treating pediatric influenza (Wind-Heat Invading the Defense Syndrome) is non-inferior to Oseltamivir with respect to clinical recovery time. Additionally, its effectiveness in terms of fever reduction, symptom alleviation, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate is comparable to that of Oseltamivir. Furthermore, it demonstrates good safety, suggesting its potential for clinical application.Clinical Trial Registration:clinicaltrials.gov, identifier ChiCTR2300076191. |
| format | Article |
| id | doaj-art-0bb7898281494a81b4e0b4fa3f3d46b9 |
| institution | OA Journals |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj-art-0bb7898281494a81b4e0b4fa3f3d46b92025-08-20T02:25:28ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-05-011610.3389/fphar.2025.15840031584003Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trialShengxuan Guo0Xinmin Li1Yuejie Zheng2Chengliang Zhong3Lei Xiong4Xi Ming5Ying Ding6Yongbin Yan7Baoqing Zhang8Peng Zhou9Zhou Fu10Jun Wang11Xuefeng Wang12Junhong Wang13Jinghua Yang14Yanxia Liu15Jianxin Cai16Lihua Ning17Xiaohong Liu18Hang Zhu19Linlin Gai20Pingding Liu21Dahong Sun22Taizhong Wang23Xiaojiao Li24Xinhua Tian25Junguang Zhang26Wenda Guan27Yupin Li28Xueming Li29Junfeng Liu30Nanyue Kuang31Ling Lu32Tongxun Gao33Haodong Liang34Kunling Shen35Rong Ma36Department of Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Respiratory Medicine, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Pediatrics, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, ChinaDepartment of Pediatrics, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, ChinaDepartment of Pediatrics, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, ChinaDepartment of Pediatrics, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, ChinaDepartment of Pediatrics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaDepartment of Pediatrics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, ChinaDepartment of Respiratory Medicine, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDepartment of Pediatrics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, ChinaDepartment of Pediatrics, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, China0Department of Pediatrics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China1Department of Pediatrics, Guangdong Provincial Hospital of Chinese Medicine, Guangdong, China2Department of Pediatrics, Shijiazhuang Maternal and Child Healthcare Hospital, Shijiazhuang, China3Department of Pediatrics, Wuhan Hospital of Traditional Chinese Medicine, Wuhan, China4Department of Pediatrics, The Fourth Hospital of Baotou, Baotou, China5Department of Pediatrics, Baoji Maternal and Child Healthcare Hospital, Baoji, China6Department of Pediatrics, 215 Hospital of Shaanxi Nuclear Industry, Xianyang, China7Department of Pediatrics, Ansteel Group General Hospital, Anshan, China8Department of Pediatrics, Weinan Maternal and Child Health Hospital, Weinan, China9Department of Pediatrics, The Affiliated Qingdao Third People’s Hospital of Qingdao University, Qingdao, China0Department of Pediatrics, Hegang People’s Hospital, Hegang, China1Department of Pediatrics, Yinchuan Traditional Chinese Medicine Hospital, Yinchuan, China2Department of Pediatrics, Zhongwei People’s Hospital, Zhongwei, China3Department of Pediatrics, Fengfeng General Hospital of North China Medical Health Group, Handan, China4Department of Pediatrics, Mudanjiang Traditional Chinese Medicine Hospital, Mudanjiang, China5Department of Pediatrics, Xi’an Daxing Hospital, Xi’an, China6Department of Pediatrics, Handan Hospital of Traditional Chinese Medicine, Handan, China7Department of Pediatrics, Handan First Hospital, Handan, China8Department of Pediatrics, Xinjiang Production and Construction Corps Hospital, Wulumuqi, China9Department of Pediatrics, Zaozhuang Municipal Hospital, Zaozhuang, ChinaDepartment of Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Respiratory Medicine, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaBackgroundXiao’er Fengre Qing Oral Liquid (XFQOL) is developed based on the classical traditional Chinese medicinal formula Yinqiao Powder. Compared to the original formulation, XFQOL exhibits enhanced heat-clearing, detoxification, and fever reduction, which can effectively address the common complications associated with influenza in children and is well-suited for pediatric use. However, there is currently a lack of high-quality evidence from clinical trials to support its efficacy and safety in clinical applications.ObjectiveThis study aimed to investigate the efficacy and safety of XFQOL compared with Oseltamivir in pediatric influenza.MethodsA multicenter, block-randomized, double-blind, double-dummy, positive-drug-controlled, non-Inferiority clinical trial design was conducted. The study plans to enroll 420 pediatric participants, with 210 in each group. The experimental group will receive XFQOL with an Oseltamivir granules placebo, and the control group will receive Oseltamivir granules with a XFQOL placebo for 5 days, followed by a 2-day post-treatment observation. The primary endpoint was clinical recovery time, while secondary endpoints included complete fever resolution time, the area under the curve (AUC) of Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom dimension Score over time, Traditional Chinese Medicine (TCM) syndrome efficacy, disappearance rates for individual symptoms, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate. Safety evaluation focused on adverse events (AE) and adverse drug reactions (ADR).ResultsA total of 418 participants were included in the Full Analysis Set, with 208 in the experimental group and 210 in the control group. Baseline characteristics were comparable between the groups. The median time to clinical recovery was 3 days for both groups, with a hazard ratio and its 95% confidence interval (experimental group/control group) of 1.115 (95% CI: 0.912–1.363). Non-inferiority testing demonstrated that the experimental group was not inferior to the control group. Subgroup analyses (positive for RT-PCR influenza, positive for RT-PCR influenza A, positive for RT-PCR influenza B) yielded results consistent with the primary endpoint. The median time to complete fever resolution was 32 h in both groups, with no statistically significant difference (P = 0.407). There were no statistically significant differences in the AUC of CARIFS symptom scores over time between the groups (P = 0.211). No significant differences were observed between the groups in the efficacy rates of TCM syndromes of Wind-Heat Invading the Defense Syndrome (P = 0.076) and Fright-complicated Syndrome (P = 0.168); however, significant differences were found in Phlegm-complicated Syndrome (P = 0.008) and Food-stagnation-complicated Syndrome (P = 0.024). The disappearance rates for individual symptoms, such as red and swollen pharynx, cough, copious sputum or audible phlegm sounds in the throat, and lack of appetite, showed statistically significant differences between the groups (P < 0.05), while no significant differences were observed for other symptoms. No statistically significant differences were observed between the experimental and control groups in the incidence of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate (P > 0.05). The incidence rates of AE (P = 0.885) and ADR (P = 0.685) were comparable between the two groups, with no statistically significant differences observed.ConclusionThe efficacy of XFQOL in treating pediatric influenza (Wind-Heat Invading the Defense Syndrome) is non-inferior to Oseltamivir with respect to clinical recovery time. Additionally, its effectiveness in terms of fever reduction, symptom alleviation, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate is comparable to that of Oseltamivir. Furthermore, it demonstrates good safety, suggesting its potential for clinical application.Clinical Trial Registration:clinicaltrials.gov, identifier ChiCTR2300076191.https://www.frontiersin.org/articles/10.3389/fphar.2025.1584003/fullXiao’er Fengre Qing oral Liquidinfluenzapediatricswind-heat invading the defense Syndrometraditional Chinese medicinemulticenter |
| spellingShingle | Shengxuan Guo Xinmin Li Yuejie Zheng Chengliang Zhong Lei Xiong Xi Ming Ying Ding Yongbin Yan Baoqing Zhang Peng Zhou Zhou Fu Jun Wang Xuefeng Wang Junhong Wang Jinghua Yang Yanxia Liu Jianxin Cai Lihua Ning Xiaohong Liu Hang Zhu Linlin Gai Pingding Liu Dahong Sun Taizhong Wang Xiaojiao Li Xinhua Tian Junguang Zhang Wenda Guan Yupin Li Xueming Li Junfeng Liu Nanyue Kuang Ling Lu Tongxun Gao Haodong Liang Kunling Shen Rong Ma Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial Frontiers in Pharmacology Xiao’er Fengre Qing oral Liquid influenza pediatrics wind-heat invading the defense Syndrome traditional Chinese medicine multicenter |
| title | Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial |
| title_full | Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial |
| title_fullStr | Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial |
| title_full_unstemmed | Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial |
| title_short | Efficacy and safety of Xiao’er Fengre Qing oral liquid versus Oseltamivir in treating pediatric influenza (wind-heat invading the defense syndrome): a multicenter, randomized, non-inferiority trial |
| title_sort | efficacy and safety of xiao er fengre qing oral liquid versus oseltamivir in treating pediatric influenza wind heat invading the defense syndrome a multicenter randomized non inferiority trial |
| topic | Xiao’er Fengre Qing oral Liquid influenza pediatrics wind-heat invading the defense Syndrome traditional Chinese medicine multicenter |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1584003/full |
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