Diarrhea-predominant Irritable Bowel Syndrome
Conditions
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.
Interventions
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
DRUGPlacebo
The placebo is the same as Tong-Xie-Yao-Fang in appearance.
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency per week | baseline(week 0), week 4, week 8, week 12 | — |
| 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. |
| Proportion of adverse events | week 4 | — |
Countries
China
Outcome results
None listed