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Completed

NCT Number: NCT02538692

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

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).

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Key information

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Teaching Hospital of Chengdu University of TCM

Chengdu, Sichuan, 610075, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tong-Xie-Yao-Fang

Drug

Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.

Other names: Tongxieyaofang

Placebo

Drug

The placebo is the same as Tong-Xie-Yao-Fang in appearance.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 2, 2015
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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