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

Phase 2

Completed

• Conditions: Diarrhea-predominant Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Tong-Xie-Yao-Fang

• Registration Number: NCT02538692
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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).

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 Timeline

• Study First Submitted: 2015-08-30
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Study Start: 2015-12
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Stool frequency per week	baseline(week 0), week 4, week 8, week 12
Proportion of adverse events	week 4

Trial Locations

Locations (1)

Teaching Hospital of Chengdu University of TCM; 🇨🇳 Chengdu, Sichuan, China