Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome

Last updated: April 17, 2017
Sponsor: Chengdu University of Traditional Chinese Medicine
Overall Status: Completed

Phase

2/3

Condition

Gastrointestinal Diseases And Disorders

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT02538692
81373644
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Being diagnosed as IBS according to the Rome III criteria;

  • Diarrhea was present for at least 75% of the time;

  • With a TCM differentiation as "liver stagnation and spleen defficiency"

  • Had a colonoscopy within a year to rule out other bowel diseases.

Exclusion

Exclusion Criteria:

  • Organic gastrointestinal disease, such as colorectal cancer, inflammatory boweldisease, advanced colonic polyp;

  • Had gastrointestinal surgery within a year;

  • Used durgs that affect gastrointestinal motility;

  • Had psychological disorder;

  • Serious disease in other system, which may bias the outcome measures.

Study Design

Total Participants: 160
Study Start date:
December 01, 2015
Estimated Completion Date:
March 31, 2017

Study Description

Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.

Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.

Connect with a study center

  • Teaching Hospital of Chengdu University of TCM

    Chengdu, Sichuan 610075
    China

    Site Not Available

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