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

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZhaoXiang Bian
• Collaborator: Chinese University of Hong Kong

Criteria

Inclusion Criteria:

1. fulfill the diagnostic criteria of diarrhea-predominant IBS (IBS-D);

2. fulfill the diagnostic criteria of diarrhea with TCM pattern of liver depression and spleen deficiency (LDSD);

3. age of 18-65 years (inclusive);

4. participants are voluntary and provide written informed consent.

Exclusion Criteria:

1. constipation-predominant, mixed or unsubtyped IBS patients;

2. severe diseases on heart, liver and kidney, hematology or cancer which is diagnosed by traditional Chinese medicines;

3. 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;

4. 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);

5. medical history of abdominal surgery (e.g. cholecystectomy, etc.);

6. drug or food allergies;

7. pregnancy or breast-feeding;

8. medical history of neurological diseases or psychiatric disorders;

9. currently participating in another clinical trial;

10. taking IBS treatment drugs within 1 week.