The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial

Xiaohui Guo,Meiling Xuan,Zehuai Wen,Shaogang Huang,Huan Zheng,Shumin Qin,Haomeng Wu

doi:10.1186/s13063-021-05444-w

Abstract

BackgroundDiarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease. Recent observational studies have reported that the Chinese herbal formula Huoxiang Zhengqi (HXZQ) can relieve IBS-D symptoms, but no high-level evidence is presented. Therefore, we want to evaluate the efficacy and safety of HXZQ for IBS-D patients.MethodsThis is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week follow-up period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures.DiscussionThis trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment.Trial registrationThe trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837. Registered on 24 October 2019.

Highlights

Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common chronic digestive disease
A systematic review demonstrated that treating Irritable bowel syndrome (IBS) with integrated traditional Chinese and western medicine was more effective than conventional western medicine alone
After patients are screened for eligibility with the following criteria and sign informed consent, they will be enrolled in the study

Summary

Methods

This is a double-blind, randomized, placebo-controlled trial. The 212 eligible patients with IBS-D will be randomly assigned to receive either HXZQ oral liquid or a placebo, at a 1:1 ratio, for 4 weeks with a 4-week followup period. Adequate relief will be the primary outcome measures. IBS symptom severity score, IBS quality-of-life questionnaire, EQ-5D-5L, and Chinese medicine symptom questionnaire will be the secondary outcome measures

Discussion

Background

Methods/design

Those who were diagnosed as having a CM dampness pattern

Findings