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 · tracked via the Priya Life Science China tracker

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Phase

Not applicable

Started

2027-01-01

Last updated

2026-07-20

Condition(s) studied

Functional DyspepsiaIrritable Bowel Syndrome With Diarrhea

Investigational drug(s) / intervention(s)

Hewei Anchang Formula GranulesHewei Anchang Formula Matching Placebo Granules

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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: 1. Meet the Rome IV diagnostic criteria for both functional dyspepsia (FD) and diarrhea-predominant irritable bowel syndrome (IBS-D). 2. Meet the diagnostic criteria for liver-stomach disharmony syndrome in FD and liver qi stagnation with spleen deficiency syndrome in IBS-D. 3. Aged 18-65 years, with no restriction on sex. 4. Fully informed about the study and voluntarily provide written informed consent. - Exclusion Criteria: 1. Severe primary diseases of the cardiovascular, hepatic, renal, hematologic, or respiratory systems, or malignant tumors. 2. 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. 3. 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. 4. A history of allergy to any study-related medication or a history of severe food allergy. 5. Psychiatric disorders, intellectual impairment, or language impairment. 6. Women who are planning pregnancy, pregnant, or breastfeeding. 7. Current participation in another drug clinical trial or participation in another drug clinical trial within the previous 4 weeks. 8. Severe anxiety or depression, as assessed using the Hospital Anxiety and Depression Scale (HADS). An anxiety subscale score of ≥15 is defined as severe anxiety, and a depression subscale score of ≥15 is defined as severe depression. Participants meeting the criterion for severe anxiety or severe depression on either subscale will be excluded. 9. A suspected or confirmed history of alcohol or drug abuse, or other circumstances that, in the investigator's judgment, may reduce the likelihood of enrollment or complicate study participation, such as frequent changes in the work environment that may increase the risk of loss to follow-up. -

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)

Facility	City	Region	Status
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07715760 on ClinicalTrials.gov ↗ ← All trials in China