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

Sponsor
Chengdu University of Traditional Chinese Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02538692
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
15
Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tong-Xie-Yao-Fang

Tong-Xie-Yao-Fang is a classic formula of traditional Chinese medicine for IBS-D. It is composed of 4 herbs: Radix Paeoniae Alba, Ledebouriella seseloides Wolff, pericarpium citri reticulatae and Rhizoma Atractylodis Macrocephalae. The granules will be administrated for thrice daily at a dose of 15g per time. The total duration of treatment is 4 weeks.

Drug: Tong-Xie-Yao-Fang
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
Other Names:
  • Tongxieyaofang

    		•
    Placebo Comparator: Placebo

    It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.

    Drug: Placebo
    The placebo is the same as Tong-Xie-Yao-Fang in appearance.

    Outcome Measures

    Primary Outcome Measures

    1. the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks. [4 weeks after initiation of treatment]

    Secondary Outcome Measures

    1. Stool frequency per week [baseline(week 0), week 4, week 8, week 12]

    2. An visual scale rating the degree of IBS-D symptoms [baseline(week 0), week 4, week 8, week 12]

      The scale ranges from 0 to 10. The score 0 indicates the mildest degree, while the 10 indicates the most serious degree.

    3. Proportion of adverse events [week 4]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Criteria:

    • Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teaching Hospital of Chengdu University of TCM Chengdu Sichuan China 610075

    Sponsors and Collaborators

    • Chengdu University of Traditional Chinese Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chengdu University of Traditional Chinese Medicine
    ClinicalTrials.gov Identifier:
    NCT02538692
    Other Study ID Numbers:
    • 81373644
    First Posted:
    Sep 2, 2015
    Last Update Posted:
    Apr 18, 2017
    Last Verified:
    Apr 1, 2017
    Additional relevant MeSH terms:
    Irritable Bowel Syndrome
    Syndrome
    Diarrhea

    Study Results

    No Results Posted as of Apr 18, 2017