Treatment of active ulcerative colitis with Yinmei Kuijie decoction combined with 5-aminosalicylic acid: A non-randomized multicenter prospective observational protocol based on real-world conditions
- Author:
Xinyu Zhang
;
Yuan Li
;
Ping Li
;
Yunze Liu
;
Junmei Zhang
;
Jingwei Wu
;
Qi Wag
;
Xia Ding
1
Author Information
1. dingx@bucm.edu.cn
- Publication Type:期刊文章
- Keywords:
Chinese medicine;
5-aminosalicylic acid;
Ulcerative colitis;
Real-world study;
Study protocol;
Observational study
- From:
Journal of Traditional Chinese Medical Sciences
2024;11(4):423-427
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-aminosalicylic acid (5-ASA) in treating mildly to moderately active ulcerative colitis (UC) under real-world conditions.
Methods:This multicenter, prospective, non-randomized, observational study will be conducted in real-world settings. A total of 204 eligible patients will be consecutively enrolled in the study. Patients in the combination treatment group will receive Yinmei Kuijie decoction in combination with 5-ASA, whereas those in the control group will be treated with 5-ASA alone. The primary endpoint will be a clinical response at week 12, defined as a ≥3 point and ≥30% reduction from baseline in the Mayo total score with ≥1 reduction in rectal bleeding or rectal bleeding score = 0 or 1. Secondary efficacy endpoints at week 12 will include health-related quality of life, mucosal healing, and inflammation indicators.
Conclusion:The results of this study may provide evidence of the efficacy and safety of Yinmei Kuijie decoction combined with 5-ASA in treating patients with mildly to moderately active UC under real-world principles. The results will provide a basis for further confirmatory studies on the efficacy of Yinmei Kuijie decoction.
