Efficacy and safety of Chinese herbal formula CDD-2103 for remission maintenance of ulcerative colitis: Study protocol for a randomized, double-blinded, placebo-controlled trial
IF 1.9 4区 医学Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE
Xuan Zhang , Hor Yue Tan , Wing Lam To , Ziwan Ning , Ka Wing Cheng , Jialing Zhang , Emily Au , Keyi Zhou , Hoi Ki Wong , Heung Lam Mok , Jiaruo Xu , Matthew Koh , Zhaoxiang Bian
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引用次数: 0
Abstract
Introduction
Ulcerative colitis (UC) is a chronic lifelong disorder and a prominent subtype of inflammatory bowel disease (IBD) globally. Studies have indicated that Chinese herbal medicines (CHM) may offer advantages in alleviating the clinical symptoms experienced by UC patients. CDD (Centre for Chinese Herbal Medicine Drug Development)-2103 is a CHM formula for maintenance of UC remission. We aim to evaluate its efficacy and safety in remission patients with a traditional Chinese medicine (TCM) pattern of spleen deficiency with dampness obstruction (SDDO).
Methods
This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. A total of 82 eligible patients will be randomized to receive either CDD-2103 or placebo for 24 weeks, followed by post-treatment monitoring at week 36 and 48. The primary outcome is the recurrence rate according to the modified Mayo Score at week 24. The secondary outcomes consist of Partial Mayo Score, Inflammatory bowel disease questionnaire (IBDQ), Simple clinical colitis activity index (SCAAI), TCM syndrome scale and safety assessment.
Conclusion
This study will provide evidence on the effectiveness and safety of CDD-2103 in reducing chance of clinical relapse for UC patients, and will further shed light on the UC remission maintenance with TCM.
Trial registration
Chinese Clinical Trial Registry, ChiCTR2100043200. Registered on 8 February 2021. https://www.chictr.org.cn/showproj.html?proj=121,692.
期刊介绍：
The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education.
EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians.
The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.
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