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

April 17, 2017 updated by: Chengdu University of Traditional Chinese Medicine

Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Teaching Hospital of Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.
Time Frame: 4 weeks after initiation of treatment
4 weeks after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency per week
Time Frame: baseline(week 0), week 4, week 8, week 12
baseline(week 0), week 4, week 8, week 12
An visual scale rating the degree of IBS-D symptoms
Time Frame: 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.
baseline(week 0), week 4, week 8, week 12
Proportion of adverse events
Time Frame: week 4
week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81373644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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