Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome
Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
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.