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Traditional Chinese Medicine for Treatment of Irritable Bowel Syndrome

NCT03135821 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2017-05-01

No results posted yet for this study

Summary

Irritable bowel syndrome (IBS) is a prevalent condition that adversely affects patient's quality of life and represents a large health care burden globally. Currently, there is no satisfactory treatment for IBS and Chinese Herbal medicine (CHM) has been suggested to be potentially useful. However, the efficacy of CHM in the treatment of IBS is unclear and its mechanism of action is unknown. To date, attempts to characterize CHM efficacy universally suffer from poor scientific method or they do not faithfully replicate authentic CHM best practice. The overall goal of this proposal is hence to address these deficiencies by combining the best of CHM with western medicine.The investigators propose a 10-week randomized, double-blind, placebo-controlled study on 104 patients that form the intersect between western medicine and CHM. The participants would fulfill ROME III criteria for IBS-Constipation predominant subtype, which is also the TCM (Traditional Chinese Medicine) syndrome of Liver Qi stagnation. The investigators will test a core herbal formula specific for treatment of Liver Qi stagnation against placebo that consist of only 10% active ingredients but which is indistinguishable by taste from active treatment. Efficacy will be assessed by comparing symptoms reported at baseline (2-week run-in period) to end of treatment (8 weeks) and an optional follow up period (12 weeks). The primary end point will be improvement in IBS-Symptom Severity Score. Mechanism of action will be explored by measuring changes to the stool microbiome and GI transit times. If successful, this trial would provide one of the first evidence- and mechanism-based approach to translate CHM into mainstream IBS management.

Conditions

  • Irritable Bowel Syndrome

Interventions

DIAGNOSTIC_TEST

TCM

Sponsors & Collaborators

  • Singapore College of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Yu Tien Wang · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03135821 on ClinicalTrials.gov