Efficacy and safety of Jiao Wei Xiao Shi decoction in patients with functional dyspepsia: A study protocol for a randomized controlled trial

Abstract

Background Functional dyspepsia (FD) is the most prevalent gastrointestinal disorder worldwide. Current medicine often faces limitations in the treatment of FD. Traditional Chinese medicine (TCM), with a history of thousands of years, offers a great contribution to Chinese people with FD. Jiao Wei Xiao Shi decoction (JWXSD) is a traditional Chinese medical prescription. However, the efficacy of JWXSD in FD is lacking. Therefore, this study will evaluate the efficacy and safety of JWXSD for the treatment of FD. Methods A randomized controlled trial will be conducted at Beijing University of Chinese Medicine. 72 participants with FD will be randomly allocated to three groups (JWXSD groups, Mosapride group and Placebogroup) at a ratio of 1:1:1. The primary outcome is Nepean Dyspepsia Symptom Index (NDSI). The secondary outcomes include the Nepean Dyspepsia Life Quality Index (NDLQI), Body Mass Index (BMI) and Pittsburgh Sleep Quality Index(PSQI). Primary and secondary outcomes will be evaluated at weeks 1, 3, 4, 8, 12 and 16. Adverse events will be assessed during the study. Discussion The outcomes from this trial will compare JWXSD, mosapride and placebo in FD participants. This study will provide clinical evidence that JWXSD can help to improve FD. Trial registration Chinese Clinical Trial Registry: ChiCTR2400082798. Registered on April 8, 2024.