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

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

doi:10.1016/j.eujim.2024.102375

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

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^*

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › peer-review

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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=121692

Original language	English
Article number	102375
Number of pages	7
Journal	European Journal of Integrative Medicine
Volume	69
Early online date	4 Jun 2024
DOIs	https://doi.org/10.1016/j.eujim.2024.102375
Publication status	Published - Aug 2024

Scopus Subject Areas

Complementary and alternative medicine

User-Defined Keywords

Chinese medicine CDD-2103
Clinical relapse
Randomized controlled trial
Study protocol
Ulcerative colitis

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.eujim.2024.102375

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Zhang, X., Tan, H. Y., To, W. L., Ning, Z., Cheng, K. W., Zhang, J., Au, E., Zhou, K., Wong, H. K., Mok, H. L., Xu, J., Koh, M., & Bian, Z. (2024). 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. European Journal of Integrative Medicine, 69, Article 102375. https://doi.org/10.1016/j.eujim.2024.102375

@article{552fede4918544158268f3a1692f2499,

title = "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",

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=121692",

keywords = "Chinese medicine CDD-2103, Clinical relapse, Randomized controlled trial, Study protocol, Ulcerative colitis",

author = "Xuan Zhang and Tan, {Hor Yue} and To, {Wing Lam} and Ziwan Ning and Cheng, {Ka Wing} and Jialing Zhang and Emily Au and Keyi Zhou and Wong, {Hoi Ki} and Mok, {Heung Lam} and Jiaruo Xu and Matthew Koh and Zhaoxiang Bian",

note = "Funding information: This work was financially supported by Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (Grant numbers. ITC RC/IHK/4/7). The funder had no role in the design of the study, collection, analysis, and interpretation of data, nor in the writing of the manuscript. The authors acknowledge the financial support of Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (Grant numbers. ITC RC/IHK/4/7). Publisher copyright: {\textcopyright} 2024 The Author(s).",

year = "2024",

month = aug,

doi = "10.1016/j.eujim.2024.102375",

language = "English",

volume = "69",

journal = "European Journal of Integrative Medicine",

issn = "1876-3820",

publisher = "Elsevier GmbH",

}

Zhang, X , Tan, HY, To, WL, Ning, Z, Cheng, KW, Zhang, J, Au, E, Zhou, K, Wong, HK, Mok, HL, Xu, J, Koh, M & Bian, Z 2024, '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', European Journal of Integrative Medicine, vol. 69, 102375. https://doi.org/10.1016/j.eujim.2024.102375

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. / Zhang, Xuan ; Tan, Hor Yue; To, Wing Lam et al.
In: European Journal of Integrative Medicine, Vol. 69, 102375, 08.2024.

Research output: Contribution to journal › Journal article › peer-review

TY - JOUR

T1 - Efficacy and Safety of Chinese Herbal Formula CDD-2103 for Remission Maintenance of Ulcerative Colitis

T2 - Study Protocol for a Randomized, Double-blinded, Placebo-controlled Trial

AU - Zhang, Xuan

AU - Tan, Hor Yue

AU - To, Wing Lam

AU - Ning, Ziwan

AU - Cheng, Ka Wing

AU - Zhang, Jialing

AU - Au, Emily

AU - Zhou, Keyi

AU - Wong, Hoi Ki

AU - Mok, Heung Lam

AU - Xu, Jiaruo

AU - Koh, Matthew

AU - Bian, Zhaoxiang

N1 - Funding information: This work was financially supported by Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (Grant numbers. ITC RC/IHK/4/7). The funder had no role in the design of the study, collection, analysis, and interpretation of data, nor in the writing of the manuscript. The authors acknowledge the financial support of Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (Grant numbers. ITC RC/IHK/4/7). Publisher copyright: © 2024 The Author(s).

PY - 2024/8

Y1 - 2024/8

N2 - 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=121692

AB - 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=121692

KW - Chinese medicine CDD-2103

KW - Clinical relapse

KW - Randomized controlled trial

KW - Study protocol

KW - Ulcerative colitis

UR - http://www.scopus.com/inward/record.url?scp=85196867581&partnerID=8YFLogxK

U2 - 10.1016/j.eujim.2024.102375

DO - 10.1016/j.eujim.2024.102375

M3 - Journal article

SN - 1876-3820

VL - 69

JO - European Journal of Integrative Medicine

JF - European Journal of Integrative Medicine

M1 - 102375

ER -

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

Abstract

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