Efficacy and safety of Qinghua Zhixie Decoction against diarrhea-predominate irritable bowel syndrome: A protocol for a randomized controlled trial

BACKGROUND: Diarrhea-predominant irritable bowel syndrome (D-IBS) is the main subtypes of irritable bowel syndrome (IBS). In recent years, more than half of IBS patients have received complementary and alternative medicine. Traditional Chinese herbal formula is widely used in Asia, and clinical studies have also found that Chinese herbal formula could significantly improve abdominal pain and diarrhea. We plan to carry out a randomized, controlled, double blind, clinical studies to observe the clinical efficacy of Qinghua Zhixie decoction in the treatment of D-IBS. METHODS: Four hundred sixty-four participants will be randomly assigned to the treatment group and control group. Patients in both groups would take medications and stimulations simultaneously. The outcomes of IBS symptom severity score, quality of life, psychological states, and recurrence rate will be recorded. Statistics will be analyzed with the SPSS 22.0. CONCLUSIONS: The findings of the study will identify the safety and efficacy of Qinghua Zhixie decoction in the treatment of D-IBS. TRIAL REGISTRATION: OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/C8MHW.