Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Sym… (NCT07715760) | Clinical Trial Compass
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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
China120 participantsStarted 2027-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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. -
Exclusion criteria
. Severe primary diseases of the cardiovascular, hepatic, renal, hematologic, or respiratory systems, or malignant tumors.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.