• Wenting Fei, Jianjun Zhang, Linyuan Wang, Yi Yang, Yan Chen, Yawen Chen, Ran Tao, and Yingli Zhu.
• School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China.
• Medicine (Baltimore). 2022 Sep 23; 101 (38): e30729.

IntroductionFunctional constipation (FC) is a common functional gastrointestinal disease and is one of the most common outpatient diseases. The purpose of this study was to investigate the efficacy and safety of the traditional Chinese medicine Besunyen Detox Tea (BDT) for FC and to compare the effect of BDT between constipation patients with and non-dryness-heat syndrome.Methods And AnalysisThis multicenter, prospective, observational registry study included 1000 participants diagnosed with FC. This study will collaborate with 3 comprehensive hospitals and 15 community hospitals and recruit patients into the registry between July 2022 and July 2023. After enrollment, we will collect the individual characteristics of each patient, anthropometric data and general condition, bowel movement, patient assessment of constipation symptoms, patient assessment of constipation quality of life, TCM syndrome scale, and time to take the laxative product again after treatment. We will also record adverse events and economic indicators at each visit.DiscussionThis is the first registry-based study to collect real-world data of participants diagnosed with FC receiving BDT treatment. The results of this registry may also reflect these characteristics and provide direct clinical evidence to verify the importance of syndrome differentiation and treatment for the use of TCM health care products.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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