NCT02538692

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

Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Tong-Xie-Yao-Fang	Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
DRUG	Placebo	The placebo is the same as Tong-Xie-Yao-Fang in appearance.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2015-09-02
• Last updated: 2017-04-18

Locations

1 site across 1 country: China