@article{7020694d02cd48c3bbb1d1de9a8ea94d,
title = "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",
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.",
keywords = "Chinese medicine JCM-16021, Diarrhea-predominant, Irritable bowel syndrome, Randomized controlled trial, Treatment",
author = "Ya Zheng and Jessica Ching and Cheng, {Chung Wah} and Lam, {Wai Ching} and Chan, {Kam Leung} and Xuan Zhang and Lam, {Pui Yan} and Wu, {Xing Yao} and Zhong, {Linda L.D.} and Cao, {Pei Hua} and Lo, {Cho Wing} and Cheong, {Pui Kuan} and Zhixiu Lin and Matthew Koh and Justin Wu and Bian, {Zhao Xiang}",
note = "Funding Information: This study is supported by the Innovative Technology Commission of Hong Kong Special Administrative Region, China (ITS/148/14FP). Funding Information: The authors acknowledge all the participants in this study and all Chinese medicine practitioners who will contribute to the study but not in the list of authors. The study is covered by a professional liability insurance policy for each participant. If there are any harm happened, the insurance company will pay the compensation according to the insurance policy. After the completion of this study, there is no other compensation to participants. The results will be reported to the Research Ethics Committee, the Department of Health, and the funding agency Innovative Technology Commission of Hong Kong Special Administrative Region. And then, all participants will be also informed of the results by phone or email. Moreover, all results of the study will be published following CONSORT Statement for Chinese Herbal Medicine Formulas. Funding Information: All data will be collected through patient diaries, questionnaires, and CRFs. All enrolled participants have to record their abdominal pain, stool frequency, stool consistency in a paper-based patient diary throughout 18 weeks of study. At each visit, participants will be required to return the diaries and complete some questionnaires, including the GAI questionnaire, the IBS-QoL questionnaire, and the IBS-SSS questionnaire. Chinese medicine practitioners and study coordinators have to fill in the CRFs to record relevant information, such as blood pressure, the changes of TCM Pattern, and compliance/noncompliance with research medication and concomitant conventional maintenance therapy, etc. These data collected in visit 2 will be the baseline data. All personal information of participants will be kept confidential. The Research Electronic Data Capture (REDCap) [, ] will be used to collect and manage all participants{\textquoteright} data by researchers. All centers have corresponding personnel to input the data timely. The researchers with authorized accounts can log in and browse the data. All raw data collected by patient diaries, questionnaires, and CRFs could be shared based on the request and special approval from the team. During the whole study, all AEs (new incurrence symptoms or diseases, abnormal vital signs, clinically significant abnormal laboratory examination) should be recorded in CRF and investigators are also required to fill in the relevant information in the “Adverse Event Report Form”, which includes start time, duration, severity, and relationship with IMP etc. Once there is an AE which results in hypersensitivity towards research medication or significant abnormality on liver or renal function, investigators can suspend or terminate the IMP, and report to principal investigators in time. If there are any SAEs, investigators should fill in the “Serious Adverse Event Report Form” with signature and report to the Research Ethics Committee within 24 h. Also, all AEs and SAEs are required to be reported to the Department of Health of Hong Kong Special Administrative Region every year. The trial document will be kept for 7 years after the completion of the trial. The Research Ethics Committee of Hong Kong Baptist University and the Department of Health of Hong Kong Special Administrative Region play a role to monitor the data. The principal investigators need to submit the progress reports to the Research Ethics Committee of Hong Kong Baptist University and the Department of Health of Hong Kong Special Administrative Region every year, and to the funding agency Innovative Technology Commission of the Government of Hong Kong Special Administrative Region at every 6 months. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = nov,
doi = "10.1186/s13020-021-00530-2",
language = "English",
volume = "16",
journal = "Chinese Medicine",
issn = "1749-8546",
publisher = "BioMed Central Ltd.",
number = "1",
}
