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

NCT07715760 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Functional Dyspepsia
  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

Hewei Anchang Formula Granules

Hewei Anchang Formula granules will be administered orally at a dose of one sachet twice daily for 4 weeks. Each dose will be dissolved in approximately 100 mL of warm water and taken 1 hour after breakfast and dinner.

DRUG

Hewei Anchang Formula Matching Placebo Granules

The matching placebo granules contain 5% Hewei Anchang Formula granules and will be administered orally at a dose of one sachet twice daily for 4 weeks. Each dose will be dissolved in approximately 100 mL of warm water and taken 1 hour after breakfast and dinner.

Sponsors & Collaborators

  • Shanghai University of Traditional Chinese Medicine

    collaborator OTHER

  • Affiliated Hospital of Nanjing University of Chinese Medicine

    collaborator OTHER

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    collaborator OTHER

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2028-06-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715760 on ClinicalTrials.gov