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A Clinical Study on the Treatment of Functional Dyspepsia and Postprandial Distress Syndrome with Depressive State Using the Yi-Qi Jie-Yu Decoction

A Clinical Study on the Treatment of Functional Dyspepsia and Postprandial Distress Syndrome with Depressive State Using the Yi-Qi Jie-Yu Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000610
Enrollment
Unknown
Registered
2026-03-18
Start date
2026-03-25
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia with Postprandial Distress Syndrome and Comorbid Depressive Disorder

Interventions

Experimental Group:Yiqi Jieyu Decoction (adjusted as needed) for oral administration. Each dose should be soaked for 30 minutes, then decocted twice to obtain 400 mL of the extract. Take one dose dail
Control Group:Mosapride Citrate 5 mg per dose, three times daily, taken orally before meals
Flupentixol and Melitracen Tablets: 1 tablet each time, twice daily.

Sponsors

Affiliated Hospital of Nanjing University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for postprandial distress syndrome (PD) or gastroparesis (GP) in Western medicine and the criteria for syndrome differentiation in traditional Chinese medicine; 2. Age between 18-65 years old; 3. Meet the diagnostic criteria for mild depressive state (SDS scale score: 53-62 points); 4. Have complete clinical data and good treatment compliance; 5).Voluntarily sign the informed consent form and be able to complete the questionnaire; 6.Patients must have a diagnosis from endoscopy, with endoscopic findings showing no abnormalities or chronic gastritis, no obvious erosion visible under the endoscope, and no significant atrophy, intestinal metaplasia, or dysplasia observed in the pathological examination.

Exclusion criteria

Exclusion criteria: 1. History of HP-positive patients; 2. Dyspepsia caused by organic diseases of the digestive system, such as peptic ulcers, gastroesophageal reflux disease (GERD), erosive gastritis (grade 2 or above), atrophic gastritis, digestive tract tumors, gastrointestinal bleeding, hepatobiliary and pancreatic diseases, intestinal obstruction, inflammatory bowel disease, etc.; 3. Systemic diseases affecting gastrointestinal motility, such as diabetes, chronic renal insufficiency, connective tissue diseases, neurological disorders, etc.; 4. Patients with severe primary diseases of the heart, brain, liver, lungs, kidneys, blood, or other conditions that significantly impact survival; 5. Patients with suicidal tendencies or mental disorders who are unable to cooperate; 6. Pregnant or breastfeeding women, or patients with plans for pregnancy in the near future; 7. Patients who have taken medications that may affect the results of this study within 2 weeks prior to participating in this study; 8. Patients with allergies or adverse reactions to the drugs used in this study.

Design outcomes

Primary

MeasureTime frame
Main Symptoms Disease Effectiveness Rating;Zung's Self-Rating Depression Scale (SDS);

Secondary

MeasureTime frame
TCM syndrome score;Niping Dyspepsia Index (NDI);Tumor necrosis factor-a;Interleukin-1ß;Interleukin-22;5-hydroxytryptamine;vasoactive intestinal peptide;

Countries

China

Contacts

Public ContactXu Yi

Affiliated Hospital of Nanjing University of TCM

xuyi999999999@163.com13851829112

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026