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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

Tracking Information
First Submitted Date  ICMJE August 30, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
Official Title  ICMJE Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diarrhea-predominant Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Tong-Xie-Yao-Fang
    Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
    Other Name: Tongxieyaofang
  • Drug: Placebo
    The placebo is the same as Tong-Xie-Yao-Fang in appearance.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tong-Xie-Yao-Fang
  • Placebo Comparator: Placebo
    It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
160
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
118
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02538692
Other Study ID Numbers  ICMJE 81373644
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chengdu University of Traditional Chinese Medicine
Study Sponsor  ICMJE Chengdu University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chengdu University of Traditional Chinese Medicine
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP