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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tong-Xie-Yao-Fang | Experimental | 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. |
|
| Placebo | Placebo Comparator | It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tong-Xie-Yao-Fang | Drug | Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool frequency per week | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching Hospital of Chengdu University of TCM | Chengdu | Sichuan | 610075 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29856472 | Derived | 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. |
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| Placebo | Drug | The placebo is the same as Tong-Xie-Yao-Fang in appearance. |
|
| baseline(week 0), week 4, week 8, week 12 |
| Proportion of adverse events | week 4 |