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| Efficacy of Kouyanqing Granule in treatment of children with recurrent aphthous ulcer (fire excess from yin deficiency syndrome): a randomized,controlled,multi-center clinical trial |
| Hits 1021 Download times 610 Received:October 30, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2021.02.10 |
| Key Words
Kouyanqing Granule;children;recurrent aphthous ulcer;traditional Chinese medicine;randomized controlled trial |
| Author Name | Affiliation | E-mail | | MA Rong | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | LI Xinmin | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | CAI Yuedong | Guangzhou Baiyunshan Heji Huangpu Traditional Chinese Medicine Co., Ltd., Guangzhou 510515, China | 497540317@qq.com | | WANG Mingyue | Pediatric Department, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, China | | | PEI Zhuying | Pediatric Department, Yuncheng Center Hospital, Yuncheng 044000, China | | | ZHANG Wei | Pediatric Department, Nanyang Traditional Chinese Medicine Hospital, Nanyang 473060, China | | | LI Guotang | Stomatology Department, Zhoukou Hospital of Traditional Chinese Medicine, Zhoukou 466000, China | | | MA Sifeng | Pediatric Department, Daqing Hospital of Traditional Chinese Medicine, Daqing 163001, China | | | HONG Lijun | Pediatric Department, Mudanjiang Hospital of Traditional Chinese Medicine, Mudanjiang 157000, China | | | ZHOU Hongxia | Pediatric Department, Yuncheng Maternal and Child Health Hospital, Yuncheng 044000, China | | | ZHANG Xiaoyan | Guangzhou Baiyunshan Heji Huangpu Traditional Chinese Medicine Co., Ltd., Guangzhou 510515, China | | | LIN Juan | Guangzhou Baiyunshan Heji Huangpu Traditional Chinese Medicine Co., Ltd., Guangzhou 510515, China | | | WU Ge | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | XU Yaqian | Pediatric Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | |
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| Abstract
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| [Objective] To evaluate the efficacy of Kouyanqing Granules in the treatment of children with recurrent aphthous ulcer (fire excess from yin deficiency syndrome),in shortening the course,reducing recurrence and relieving pain,and observe the safety of clinical application. [Methods] A randomized,double-blind,placebo-controlled,multi-center clinical study was used. The trial intended to include 144 patients,who were randomly divided into treatment group and control group according to 1:1 ratio. The treatment group was given Kouyanqing Granules and the control group with kouyanqing Granules placebo for 14 days. [Results] A total of 144 patients were assigned to this study. During the experiment,6 patients in the test group and 4 patients in the placebo group were not included in the FAS due to dropping out,out of visit window and violation of inclusion and exclusion criteria. The median ulcer healing time was 12 days in the treatment group and 14 days in the placebo group (P<0.05). The recurrence rate was 42.11% in the treatment group and 76.47% in the placebo group (P<0.05). From the 5th day to the 14th day,the differences between the pain VAS score of the treatment group and the placebo group were statistically significant (P<0.05). And the effective rate of traditional Chinese medicine syndromes was 100% and 51.39% (P>0.05). In this trial,there were 1 case (1.45%) of adverse events in the treatment group and 3 cases (4.35%) in the control group (P>0.05). [Conclusion] Kouyanqing Granules in the treatment of children with recurrent aphthous ulcer (fire excess from yin deficiency syndrome) can shorten the course clearly,reduce recurrence,relieve pain and improve traditional Chinese medicine syndromes,and the security is good. |
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