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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03457324
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : August 19, 2020
Chinese University of Hong Kong
Information provided by (Responsible Party):
ZhaoXiang Bian, Hong Kong Baptist University

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 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: JCM-16021 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: a Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: JCM-16021 Group
JCM-16021 granules 8g/sachet, three times daily for 8 weeks.
Drug: JCM-16021
This prescription with seven ingredients.

Placebo Comparator: Placebo Group
Placebo granules 8g/sachet, three times daily for 8 weeks
Drug: Placebo

Primary Outcome Measures :
  1. Global Assessment of Improvement (GAI) score [ Time Frame: 16 weeks ]
    The global symptom improvement will be evaluated by scales (terrible=0, worse=1, slightly worse=2, no change=3, slightly better=4, better=5, excellent=6).

Secondary Outcome Measures :
  1. Pain responder rate in daily worst abdominal pain scores [ Time Frame: 16 weeks ]
    Pain responders are defined as that participants who met the daily pain response criteria for at least 50% of the days with diary entries during the observational period of interest. Daily pain response: decrease in the worst abdominal pain scores in the past 24 hours of ≥ 30% compared to baseline (average of daily worst abdominal pain the 2-week prior to randomization). Pain score is ranked from 0 to 10 represented none to most severe.

  2. Stool consistency responder rate In daily stool consistency scores [ Time Frame: 16 weeks ]
    Stool consistency responders are defined as that participants who met daily stool consistency response criterion (ie, score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% decrease in worst abdominal pain scores compared to baseline pain) for at least 50% of days with diary entries during the observational period of interest. Bristol stool scale is defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.

  3. Efficacy judgement standard of single symptom [ Time Frame: 16 weeks ]
    1. Excellent: symptom disappearing;
    2. Effective: symptom decreased, scoring declining more than 2 points (including 2 points);
    3. Helpful: symptom decreased, scoring declining between 1 point to 2 points;
    4. Invalid: no change in symptom. Improvement contains excellent, effective and helpful. Each cardinal symptom total improvement rate will be calculated and then conducted symptom evaluation.

  4. Comprehensive efficacy judgement standard of cardinal symptoms [ Time Frame: 16 weeks ]
    The symptom improvement rate is calculated by "(total scoring of prior treatment - total scoring of post treatment) / total scoring of prior treatment × 100%". Clinical remission is defined as symptom disappearing, symptom improvement rate equal or greater than 80% is excellent, symptom improvement rate between 50% and 80% is helpful, symptom improvement rate under 50% is invalid, and negative symptom improvement rate is deterioration. Total effective rate is based on recovery and excellent cases.

  5. TCM pattern improvement [ Time Frame: 16 weeks ]
    Clinical remission: clinical symptoms and signs disappear or basically disappear, total scoring declining ≥95%; Excellence: clinical symptoms and signs are significantly improved, total scoring declining ≥ 70%; Effective: clinical symptoms and signs are improved, total scoring declining ≥ 30%; Invalid: clinical symptoms and signs are without obvious improvement or even with exacerbation, total scoring declining < 30%. Remark: calculation formula (nimodipine method) is: [(scoring of prior treatment - scoring of post treatment) / scoring of prior treatment]×100%

  6. Quality of life scoring (IBS-QoL) [ Time Frame: 16 weeks ]
    IBS-QoL includes 34 items and divides into 8 subscales, i.e. dysphoria (Q1), interference with activity (Q2), body image (Q3), health worry (Q4), food avoidance (Q5), social reaction (Q6), sexual (Q7) and relationship (Q8). Each item has a five-point response scale with reverse scoring. After conversion, total scoring will be in 0-100 range. Higher scoring reflects superior quality of life.

  7. Irritable Bowel Syndromes-Symptom Severity Score (IBS-SSS) [ Time Frame: 16 weeks ]
    The IBS-SSS is involved five aspects: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal discomfort, defecation satisfaction, and interference with daily life. The range of score is 0-500 points scale.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03457324

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Contact: Zhaoxiang Bian, ph.D 34112905 ext 34112929

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China, Hong Kong
Chinese Medicine Clinics of Hong Kong Baptist University Recruiting
Hong Kong, Hong Kong, China
Contact: Zhao-xiang Bian, PhD    852-34112905   
Institute of Digestive Disease, The Chinese University of Hong Kong Not yet recruiting
Hong Kong, China
Contact: Justin Wu, M.D    2632 3524   
Sponsors and Collaborators
ZhaoXiang Bian
Chinese University of Hong Kong
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Principal Investigator: Justin Wu, M.D. Chinese University of Hong Kong
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Responsible Party: ZhaoXiang Bian, Chair Professor of Clinical Division, Hong Kong Baptist University Identifier: NCT03457324    
Other Study ID Numbers: ITS-148-14FP
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will submit the study protocol and clinical study report with the informed consent form for publication.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The study protocol will be submitted during study recruitment, while the clinical study report with the informed consent form will be submitted within 1 year after the completion of study.
Access Criteria: All researchers can get the information by sending requests to the study contact person.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZhaoXiang Bian, Hong Kong Baptist University:
Irritable Bowel Syndrome
Chinese Medicine
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases