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

Primary Purpose

Diarrhea-predominant Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tong-Xie-Yao-Fang
Placebo
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea-predominant Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Teaching Hospital of Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tong-Xie-Yao-Fang

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.

Secondary Outcome Measures

Stool frequency per week
An visual scale rating the degree of IBS-D symptoms
The scale ranges from 0 to 10. The score 0 indicates the mildest degree, while the 10 indicates the most serious degree.
Proportion of adverse events

Full Information

First Posted
August 30, 2015
Last Updated
April 17, 2017
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02538692
Brief Title
Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-predominant Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tong-Xie-Yao-Fang
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.
Intervention Type
Drug
Intervention Name(s)
Tong-Xie-Yao-Fang
Other Intervention Name(s)
Tongxieyaofang
Intervention Description
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo is the same as Tong-Xie-Yao-Fang in appearance.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Stool frequency per week
Time Frame
baseline(week 0), week 4, week 8, week 12
Title
An visual scale rating the degree of IBS-D symptoms
Description
The scale ranges from 0 to 10. The score 0 indicates the mildest degree, while the 10 indicates the most serious degree.
Time Frame
baseline(week 0), week 4, week 8, week 12
Title
Proportion of adverse events
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Teaching Hospital of Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29856472
Citation
Chen M, Tang TC, Wang Y, Shui J, Xiao XH, Lan X, Yu P, Zhang C, Wang SH, Yao J, Zheng H, Huang DQ. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Jul;48(2):160-168. doi: 10.1111/apt.14817. Epub 2018 Jun 1.
Results Reference
derived

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

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