Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT02538692|
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea-predominant Irritable Bowel Syndrome||Drug: Tong-Xie-Yao-Fang Drug: Placebo||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||March 2017|
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.
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
Other Name: Tongxieyaofang
Placebo Comparator: Placebo
It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.
The placebo is the same as Tong-Xie-Yao-Fang in appearance.
- 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 [ Time Frame: 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 [ Time Frame: week 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538692
|Teaching Hospital of Chengdu University of TCM|
|Chengdu, Sichuan, China, 610075|