Journal of Traditional Chinese Medical Sciences 2024;11(4):423-427

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

Xinyu Zhang ; Yuan Li ; Ping Li ; Yunze Liu ; Junmei Zhang ; Jingwei Wu ; Qi Wag ; Xia Ding 1

Affiliations

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Keywords

Chinese medicine; 5-aminosalicylic acid; Ulcerative colitis; Real-world study; Study protocol; Observational study

Country

China

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.