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 | Not Yet Recruiting DMC

• 1 other identifier: CI2026A01002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Keywords

Hewei Anchang Formula; Overlapping Gastrointestinal Symptoms; Functional Gastrointestinal Disorders; Traditional Chinese Medicine; Chinese Herbal Medicine; Gut Microbiota; Metagenomics; Metabolomics

Outcome Measures

Primary Outcomes (3)

• Functional Dyspepsia Symptom Severity Scale Scores

  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).

  Baseline (Day 0), Week 2, Week 4, and Week 8

• Global Impression Scale for Dyspepsia Symptom Relief

  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.

  Baseline (Day 0), Week 2, Week 4, and Week 8

• Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) Score

  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.

  Baseline (Day 0), Week 2, Week 4, and Week 8

Secondary Outcomes (5)

• Traditional Chinese Medicine Syndrome Score

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days

• Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QOL) Score

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days

• Patient-Reported Outcome (PRO) Scale Total Score

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days

• 36-Item Short Form Health Survey (SF-36) Scores

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days

• Hospital Anxiety and Depression Scale (HADS) Score

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, Week 4 ± 3 days, and Week 8 ± 3 days

Other Outcomes (2)

• Fecal Gut Microbiome Metagenomic Profiles

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, and Week 4 ± 3 days

• Blood and Urine Metabolomic Profiles

  Baseline (Day 0 ± 3 days), Week 2 ± 3 days, and Week 4 ± 3 days

Study Arms (2)

Hewei Anchang Formula Group

EXPERIMENTAL

Participants assigned to this group will receive Hewei Anchang Formula granules orally, 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 Granules

Placebo Group

PLACEBO COMPARATOR

Participants assigned to this group will receive matching placebo granules containing 5% Hewei Anchang Formula granules, 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

Interventions

Hewei Anchang Formula Granules DRUG

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 Group

Hewei Anchang Formula Matching Placebo Granules DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.
• Psychiatric disorders, intellectual impairment, or language impairment.
• Women who are planning pregnancy, pregnant, or breastfeeding.
• Current participation in another drug clinical trial or participation in another drug clinical trial within the previous 4 weeks.
• 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.
• 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. -

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• 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

Study Sites (1)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Lin Lv

CONTACT

86-18811782728; lushangshitou@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)