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

Chengdu University of Traditional Chinese Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Treatments: Drug: Tong-Xie-Yao-Fang; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02538692

81373644

Details and patient eligibility

About

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).

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Tong-Xie-Yao-Fang

Experimental group

Description:

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.

Treatment:

Drug: Tong-Xie-Yao-Fang

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo