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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Diarrhea-predominant Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Tong-Xie-Yao-Fang

Intervention Type DRUG

Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Tong-Xie-Yao-Fang

Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Tongxieyaofang

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No