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

Autor: Xiaohui Guo, Meiling Xuan, Huan Zheng, Shumin Qin, Haomeng Wu, Shaogang Huang, Zehuai Wen
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Trials, Vol 22, Iss 1, Pp 1-8 (2021)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-021-05444-w
Popis: Abstract Background Diarrhea-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. 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 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. Discussion This trial aims to demonstrate the efficacy and safety of HXZQ for IBS-D, which is expected to be an effective IBS-D treatment. Trial registration The trial was registered with the Chinese Clinical Trial Registry, ChiCTR1900026837 . Registered on 24 October 2019.
Databáze: Directory of Open Access Journals