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Cited by 15

The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.

Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial

Zheng, Ya, Ching, Jessica, Cheng, Chung Wah, Lam, Wai Ching, Chan, Kam Leung, Zhang, Xuan, Lam, Pui Yan, Wu, Xing Yao, Zhong, Linda L. D., Cao, Pei Hua, Lo, Cho Wing, Cheong, Pui Kuan, Lin, Zhixiu, Koh, Matthew, Wu, Justin, Bian, Zhao Xiang·2021·Chinese Medicine
DOI 10.1186/s13020-021-00530-2

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Abstract

Background: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). Methods: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results: A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. Conclusion: The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. Trial registration : ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1

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Research works printed but not linked: 28

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Metadata

Authors
Zheng, Y., Ching, J., Cheng, C. W., Lam, W. C., Chan, K. L., Zhang, X., Lam, P. Y., Wu, X. Y., Zhong, L. L. D., Cao, P. H., Lo, C. W., Cheong, P. K., Lin, Z., Koh, M., Wu, J., & Bian, Z. X.
ORCID
Bian, Zhao Xiang
Venue
Chinese Medicine
Publisher
Springer Science and Business Media LLC
Published
2021-11-13
Volume
16
Issue
1
ISSN
1749-8546
DOI
10.1186/s13020-021-00530-2
Cited by
15
References
9
Language
en
Licence
Funders
The Innovative Technology Commission of HKSAR, China (ITS-148-14FP)

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CoChat. (2026). Citation check: Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial. https://app.cochat.ai/papers/10.1186/s13020-021-00530-2
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Zheng, Y., Ching, J., Cheng, C. W., Lam, W. C., Chan, K. L., Zhang, X., Lam, P. Y., Wu, X. Y., Zhong, L. L. D., Cao, P. H., Lo, C. W., Cheong, P. K., Lin, Z., Koh, M., Wu, J., & Bian, Z. X. (2021). Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial. Chinese Medicine. https://doi.org/10.1186/s13020-021-00530-2

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