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

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538692
• Other study ID #: 81373644
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 30, 2015
• Last updated: April 17, 2017
• Start date: December 2015
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Tong-Xie-Yao-Fang
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
• Placebo
The placebo is the same as Tong-Xie-Yao-Fang in appearance.

Locations

Country	Name	City	State
China	Teaching Hospital of Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stool frequency per week		baseline(week 0), week 4, week 8, week 12
Secondary	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.	baseline(week 0), week 4, week 8, week 12
Secondary	Proportion of adverse events		week 4