NCT03457324

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
392

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 8, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

February 8, 2018

Last Update Submit

August 16, 2020

Conditions

Irritable Bowel Syndrome

Keywords

JCM-16021TrialIrritable Bowel SyndromeChinese Medicine

Outcome Measures

Primary Outcomes (1)

  • Global Assessment of Improvement (GAI) score

    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).

    16 weeks

Secondary Outcomes (7)

  • Pain responder rate in daily worst abdominal pain scores

    16 weeks

  • Stool consistency responder rate In daily stool consistency scores

    16 weeks

  • Efficacy judgement standard of single symptom

    16 weeks

  • Comprehensive efficacy judgement standard of cardinal symptoms

    16 weeks

  • TCM pattern improvement

    16 weeks

  • +2 more secondary outcomes

Study Arms (2)

JCM-16021 Group

EXPERIMENTAL

JCM-16021 granules 8g/sachet, three times daily for 8 weeks.

Drug: JCM-16021

Placebo Group

PLACEBO COMPARATOR

Placebo granules 8g/sachet, three times daily for 8 weeks

Drug: Placebo

Interventions

JCM-16021DRUG

This prescription with seven ingredients.

JCM-16021 Group
PlaceboDRUG

Placebo

Placebo Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese Medicine Clinics of Hong Kong Baptist University

Hong Kong, Hong Kong, China

RECRUITING

Institute of Digestive Disease, The Chinese University of Hong Kong

Hong Kong, China

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 40639240DERIVED

  • 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.

    PMID: 34774080DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

JCM-16021

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Justin Wu, M.D.

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoxiang Bian, ph.D

CONTACT

34112905bzxiang@hkbu.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair Professor of Clinical Division

Study Record Dates

First Submitted

February 8, 2018

First Posted

March 7, 2018

Study Start

November 8, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 19, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

We will submit the study protocol and clinical study report with the informed consent form for publication.

Shared Documents
STUDY PROTOCOL, ICF, 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.

Locations

CN(2)