- 2022-09-23
- Medicine 101(38)
- Wenting Fei
- Jianjun Zhang
- Linyuan Wang
- Yi Yang
- Yan Chen
- Yawen Chen
- Ran Tao
- Yingli Zhu
Study Design
- Type
- Observational
- Sample size
- n = 1,000
- Population
- 1000 participants diagnosed with FC
- Methods
- Multicenter, prospective, observational registry study; collaboration with 3 comprehensive hospitals and 15 community hospitals; recruit patients into the registry between July 2022 and July 2023
- Duration
- July 2022 to July 2023
Introduction
Functional 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 analysis
This 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.Discussion
This 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.