Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome

Summary

This is a multicenter, randomized, double-blind, placebo controlled clinical trial, in order to evaluate the efficacy and safety of Chinese Medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome. All patients will be evaluated for study eligibility at Visits 1 (baseline) and 2 (2 weeks). On visit 2, patients who meet the criteria will be randomly assigned to receive 8-week treatment of either JCM-16021 Granules or JCM-16021 placebo Granules. The investigators, research assistants and participants are not aware of the treatment assignments throughout the study. Treatment codes will only be broken after the completion of study. The assessments at Visit 3 (4-week post treatment) and at visit 4 (end of 8-week treatment) are used to measure treatment response (i.e. changes from baseline). Assessment at visit 5 (end of 8-week follow up) is to determine any sustained response to treatment. All the visits will be carried out in HKBU and CUHK clinics.

Timeline

Start

2018-11-08

Primary completion

2021-06-30

Completion

2021-06-30

Publications

• Xu S, Lyu J, Bao G, Zheng P, Li Y, Ning Z, Li B, Zhuang M, Wong HK, Wang M, Zeng Y, Zheng Y, Luo J, Liu Q, Zhang L, Lin C, Xiao H, Yuan CS, Wong HLX, Bian Z, Zhai L. Gut bacteria that produce fatty acid ethanolamides alleviate diarrhea-predominant IBS with insulin resistance. Cell Host Microbe. 2026 Jul 8;34(7):1350-1366.e8. doi: 10.1016/j.chom.2026.05.020. Epub 2026 Jun 19.
• Zhai L, Zheng Y, Lo CW, Xu S, Jiang X, Liu Q, Ching JY, Ning Z, Bao G, Yang W, Zhang Q, Cheng CW, Lam WC, Chan KL, Zhang X, Lam PY, Wu XY, Zhong LLD, Cao PH, Koh M, Cheong PK, Lin Z, Lin C, Zhao L, Wong XHL, Wu JC, Bian Z. Butyrate-producing commensal bacteria mediates the efficacy of herbal medicine JCM-16021 on abdominal pain in diarrhea-predominant irritable bowel syndrome: a randomized clinical trial. Phytomedicine. 2025 Sep;145:157040. doi: 10.1016/j.phymed.2025.157040. Epub 2025 Jul 1.
• Zheng Y, Ching J, Cheng CW, Lam WC, Chan KL, Zhang X, Lam PY, Wu XY, Zhong LLD, Cao PH, Lo CW, Cheong PK, Lin Z, Koh M, Wu J, Bian ZX. 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. Chin Med. 2021 Nov 13;16(1):117. doi: 10.1186/s13020-021-00530-2.

Drugs

Indications