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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Functional Dyspepsia Symptom Severity Scale Scores — Baseline (Day 0), Week 2, Week 4, and Week 8
  The scale assesses the frequency and severity of four functional dyspepsia symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning. For each symptom, frequency is rated on a 5-point scale ranging from 1 (never) to 5 (present throughout the day), and severity is rated on a 4-point scale ranging from 1 (none) to 4 (severe).
• Global Impression Scale for Dyspepsia Symptom Relief — Baseline (Day 0), Week 2, Week 4, and Week 8
  Participants will evaluate the overall relief of dyspepsia-related symptoms during the previous 2 weeks using a 7-point scale: 1 = markedly worse, 2 = worse, 3 = slightly worse, 4 = no relief, 5 = slight relief, 6 = marked relief, and 7 = complete relief. Higher scores indicate greater overall symptom relief.
• Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) Score — Baseline (Day 0), Week 2, Week 4, and Week 8
  The IBS-SSS assesses abdominal pain severity, the number of days with abdominal pain during a 14-day period, abdominal distension severity, satisfaction with bowel habits, and the extent to which irritable bowel syndrome interferes with daily life. Higher scores indicate greater symptom severity.

Trial sites (1)

More Xiyuan Hospital of China Academy of Chinese Medical Sciences trials in China

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