1. To conduct a multicenter, randomized controlled trial across four hospitals to evaluate the efficacy of Hewei Anchang Formula in patients with overlapping gastrointestinal symptoms of functional dyspepsia (FD) and diarrhea-predominant irritable bowel syndrome (IBS-D), characterized by liver-stomach disharmony syndrome and liver stagnation-spleen deficiency syndrome, respectively. By leveraging the holistic regulatory effects of Chinese herbal formulas and the traditional Chinese medicine principle of "treating different diseases with the same therapeutic approach," this study aims to generate high-level evidence for the management of overlapping gastrointestinal symptoms in functional gastrointestinal disorders (FGIDs) and to establish a standardized and scalable therapeutic strategy. 2. To elucidate the potential mechanisms underlying the therapeutic effects of Hewei Anchang Formula on overlapping gastrointestinal symptoms of FD and IBS-D through multiple targets and pathways, with particular emphasis on modulation of the gut microbiota and the neuroendocrine-immune network.
Meet the Rome IV diagnostic criteria for both functional dyspepsia (FD) and diarrhea-predominant irritable bowel syndrome (IBS-D).
Meet the diagnostic criteria for liver-stomach disharmony syndrome in FD and liver qi stagnation with spleen deficiency syndrome in IBS-D.
Aged 18-65 years, with no restriction on sex.
Fully informed about the study and voluntarily provide written informed consent. -
Severe primary diseases of the cardiovascular, hepatic, renal, hematologic, or respiratory systems, or malignant tumors.
Other organic gastrointestinal diseases, such as peptic ulcer or ulcerative colitis, or systemic diseases that may affect gastrointestinal motility, such as hyperthyroidism or diabetes mellitus.
Current or anticipated continuous use of medications that may affect gastrointestinal function, including prokinetic agents, antidiarrheal agents, antidepressants, anxiolytics, gut microbiota-modulating agents, and antibiotics.
A history of allergy to any study-related medication or a history of severe food allergy.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator