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...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Ya Zheng, Jessica Ching, Chung Wah Cheng, Wai Ching Lam, Kam Leung Chan, Xuan Zhang, Pui Yan Lam, Xing Yao Wu, Linda L. D. Zhong, Pei Hua Cao, Cho Wing Lo, Pui Kuan Cheong, Zhixiu Lin, Matthew Koh, Justin Wu, Zhao Xiang Bian
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Irritable bowel syndrome Diarrhea-predominant Randomized controlled trial Chinese medicine JCM-16021 Treatment Other systems of medicine RZ201-999
Acceso en línea:	https://doaj.org/article/5c86824aab01446da4c1080bb27873d0
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:5c86824aab01446da4c1080bb27873d0
record_format	dspace
spelling	oai:doaj.org-article:5c86824aab01446da4c1080bb27873d02021-11-14T12:10:24ZEfficacy 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 trial10.1186/s13020-021-00530-21749-8546https://doaj.org/article/5c86824aab01446da4c1080bb27873d02021-11-01T00:00:00Zhttps://doi.org/10.1186/s13020-021-00530-2https://doaj.org/toc/1749-8546Abstract 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=1Ya ZhengJessica ChingChung Wah ChengWai Ching LamKam Leung ChanXuan ZhangPui Yan LamXing Yao WuLinda L. D. ZhongPei Hua CaoCho Wing LoPui Kuan CheongZhixiu LinMatthew KohJustin WuZhao Xiang BianBMCarticleIrritable bowel syndromeDiarrhea-predominantRandomized controlled trialChinese medicine JCM-16021TreatmentOther systems of medicineRZ201-999ENChinese Medicine, Vol 16, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Irritable bowel syndrome Diarrhea-predominant Randomized controlled trial Chinese medicine JCM-16021 Treatment Other systems of medicine RZ201-999
spellingShingle	Irritable bowel syndrome Diarrhea-predominant Randomized controlled trial Chinese medicine JCM-16021 Treatment Other systems of medicine RZ201-999 Ya Zheng Jessica Ching Chung Wah Cheng Wai Ching Lam Kam Leung Chan Xuan Zhang Pui Yan Lam Xing Yao Wu Linda L. D. Zhong Pei Hua Cao Cho Wing Lo Pui Kuan Cheong Zhixiu Lin Matthew Koh Justin Wu Zhao Xiang Bian 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
description	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
format	article
author	Ya Zheng Jessica Ching Chung Wah Cheng Wai Ching Lam Kam Leung Chan Xuan Zhang Pui Yan Lam Xing Yao Wu Linda L. D. Zhong Pei Hua Cao Cho Wing Lo Pui Kuan Cheong Zhixiu Lin Matthew Koh Justin Wu Zhao Xiang Bian
author_facet	Ya Zheng Jessica Ching Chung Wah Cheng Wai Ching Lam Kam Leung Chan Xuan Zhang Pui Yan Lam Xing Yao Wu Linda L. D. Zhong Pei Hua Cao Cho Wing Lo Pui Kuan Cheong Zhixiu Lin Matthew Koh Justin Wu Zhao Xiang Bian
author_sort	Ya Zheng
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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	BMC
publishDate	2021
url	https://doaj.org/article/5c86824aab01446da4c1080bb27873d0
work_keys_str_mv	AT yazheng efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT jessicaching efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT chungwahcheng efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT waichinglam efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT kamleungchan efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT xuanzhang efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT puiyanlam efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT xingyaowu efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT lindaldzhong efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT peihuacao efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT chowinglo efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT puikuancheong efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT zhixiulin efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT matthewkoh efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT justinwu efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial AT zhaoxiangbian efficacyandsafetyofchinesemedicinejcm16021fordiarrheapredominantirritablebowelsyndromestudyprotocolforamulticenterrandomizeddoubleblindplacebocontrolledclinicaltrial
_version_	1718429405087268864

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

Ejemplares similares