Status:
UNKNOWN
Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome
Lead Sponsor:
ZhaoXiang Bian
Collaborating Sponsors:
Chinese University of Hong Kong
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Sample size calculation: Sample size is calculated on the basis of primary efficacy variables. From our previous study, the global assessment of improvement (GAI) were 52% in herbal medicine group an...
Eligibility Criteria
Inclusion
- fulfill the diagnostic criteria of diarrhea-predominant IBS (IBS-D);
- fulfill the diagnostic criteria of diarrhea with TCM pattern of liver depression and spleen deficiency (LDSD);
- age of 18-65 years (inclusive);
- participants are voluntary and provide written informed consent.
Exclusion
- constipation-predominant, mixed or unsubtyped IBS patients;
- severe diseases on heart, liver and kidney, hematology or cancer which is diagnosed by traditional Chinese medicines;
- medical history of organic gastrointestinal diseases (e.g. inflammatory bowel diseases, intestinal tuberculosis, colon polyps), or systemic diseases which could affect gastrointestinal motility (e.g. hyperthyroidism, diabetes mellitus, chronic renal failure, neuropsychiatric diseases) which is diagnosed by traditional Chinese medicines;
- current concomitant medication with effects on gastrointestinal function (e.g. anticholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics and intestinal flora regulating drugs);
- medical history of abdominal surgery (e.g. cholecystectomy, etc.);
- drug or food allergies;
- pregnancy or breast-feeding;
- medical history of neurological diseases or psychiatric disorders;
- currently participating in another clinical trial;
- taking IBS treatment drugs within 1 week.
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT03457324
Start Date
November 8 2018
End Date
June 30 2021
Last Update
August 19 2020
Active Locations (2)
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1
Chinese Medicine Clinics of Hong Kong Baptist University
Hong Kong, Hong Kong, China
2
Institute of Digestive Disease, The Chinese University of Hong Kong
Hong Kong, China