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| Efficacy and safety of double dose Baoerkang powder in children with chronic persistent diarrhea disease of damp retention due to spleen deficiency: A block randomized, double-blind, positive-controlled, parallel to the original dose, multi-center clinical trials |
| Hits 1616 Download times 1324 Received:December 28, 2017 |
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| DOI
10.11656/j.issn.1672-1519.2018.05.02 |
| Key Words
Baoerkang powder;Zhixieling granule;RCT;children with chronic persistent diarrhea disease |
| Author Name | Affiliation | E-mail | | ZHONG Chengliang | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | HU Siyuan | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | husiyuan1963@sina.com | | GUO Shengxuan | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | LI Xinmin | The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | | HAN Xuanming | The Second Hospital Affiliated of Shanxi University of Traditional Chinese Medicine, Xianyang 712000, China | | | XIE Xiaoli | Chengdu Women and Children Center Hospital, Chengdu 610000, China | | | PAN Shuqiang | Qinzhou City Maternal and Child Health Care, Qinzhou 535000, China | | | XU Guiping | Huizhou Traditional Chinese Medicine Hospital, Huizhou 516000, China | | | ZHAN Zhiping | Guizhou Province Qiannan Buyi and Miao Autonomous Prefecture Chinese Medicine Hospital, Guizhou 558000, China | | | QUAN Xichun | Nanyang Traditional Chinese Medicine Hospital, Nanyang 473000, China | | | SU Baoling | Heji Affiliated Hospital of Changzhi Medical College, Changzhi 046000, China | | | DU Yonggang | Changzhi People's Hospital, Changzhi 046000, China | | | LIU Yufeng | The Fourth Hospital Affiliated of Liaoning University of Traditional Chinese Medicine, Shenyang 110000, China | | | MA Sifeng | Daqing Chinese Medicine Hospital, Daqing 163000, China | | | HONG Lijun | Mudanjiang Chinese Medicine Hospital, Mudanjiang 157000, China | | | SHAO Rongchang | Ezhou Central Hospital, Ezhou 436000, China | | | WANG Aizhen | Taizhou Traditional Chinese Medicine Hospital, Taizhou 225300, China | | | LI Xueming | HandanTraditional Chinese Medicine Hospital, Handan 056000, China | |
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| Abstract
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| [Objective] To evaluatethetherapeutic effect of Baoerkang powder of different doses on chronic persistent diarrhea disease with syndrome of dampness stagnancy due to spleen deficiency in children, as well as shortening the course and improvement of traditional Chinese medicine syndrome, while observing the safety of clinical applications.[Methods] A randomized, double-blind, double-dummy, parallel, active-controlled and multi-center clinical research method was adopted. The 168 patients of 15 centers were enrolled and randomly separated into double dose group, original dose group and control group(Zhixieling granules) in the rate of 1:1:1. Treatment course lasted for 5 days. Diarrhea efficacy, traditional Chinese medicine syndrome efficacy,antidiarrheal time, single symptom efficacy were observed. And the security was evaluated.[Results] The total effective rate of diarrhea was 89.29% in the double dose group,69.09% in the original dose group and 65.45% in the control group. There was statistical difference amongthe three groups. The double dose group was superior to the original dose group and the control group. the median antidiarrheal time were 4 days, 5 days and 5 days in double dose group, low dose group and control group,respectively. Double dose group recover faster, and there is significant difference between them. The total effective rate of traditional Chinese medicine syndrome efficacy was 94.64% in the double dose group,89.09% in the original dose group and 81.82% in the control group. There was statistical difference among the three groups. The double dose group was superior to the control group,and the same for single symptoms,such as thin sloppy stool and increased stool frequency. During the study,there were 1 case (1.79%) adverse event in the original dose group. The researchers determined that it had nothing to do with the experimental medication.[Conclusion] Baoerkang powder in double dose that has the effect of improving the symptoms of diarrhea, shortening the course and improving traditional Chinese medicine syndrome was superior to the control dose group(Zhixieling granules)and the original group(the dosage of instructions)on treating chronic persistent diarrhea disease with syndrome of dampness stagnancy due to spleen deficiency in children, and has good safety. |
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