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Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02538692
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine

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).

Condition or disease Intervention/treatment Phase
Diarrhea-predominant Irritable Bowel Syndrome Drug: Tong-Xie-Yao-Fang Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Tong-Xie-Yao-Fang
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.
Drug: Tong-Xie-Yao-Fang
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.
Drug: Placebo
The placebo is the same as Tong-Xie-Yao-Fang in appearance.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Stool frequency per week [ Time Frame: baseline(week 0), week 4, week 8, week 12 ]
  2. 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.

  3. Proportion of adverse events [ Time Frame: week 4 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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China, Sichuan
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02538692    
Other Study ID Numbers: 81373644
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases