Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome

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.

NCT Number	NCT07715760
Lead Sponsor	Xiyuan Hospital of China Academy of Chinese Medical Sciences Collaborators: Shanghai University of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions	Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea
Enrollment	120 participants
Start Date	2027-01-01
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-20