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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
The placebo is the same as Tong-Xie-Yao-Fang in appearance.
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
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
Stool frequency per week
Time frame: baseline(week 0), week 4, week 8, week 12
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.
Time frame: baseline(week 0), week 4, week 8, week 12
Proportion of adverse events
Time frame: week 4
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