Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538692
|Teaching Hospital of Chengdu University of TCM|
|Chengdu, Sichuan, China, 610075|