Zuojin Wan Combined With Rabeprazole or Mosapride for the Treatment of Functional Dyspepsia Combined With Depression

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a traditional Chinese medicine called Zuojin Wan when combined with either rabeprazole or mosapride to treat functional dyspepsia (a condition that causes discomfort or pain in the upper abdomen) in patients who also have mild depression. The researchers want to see if this combination helps improve symptoms better than the other medications alone and how well patients stick to their treatment. They will also look for any side effects from the medications.

To be eligible for this trial, participants must be between 18 and 65 years old and meet specific criteria for both functional dyspepsia and mild depression. They should have undergone a gastroscopy (a type of examination of the stomach) that shows no serious abnormalities. People who have certain digestive diseases, severe health issues, or are pregnant or breastfeeding cannot participate. If you join the trial, you can expect regular check-ins to monitor your symptoms and any side effects, and it’s a chance to contribute to research that could help others with similar conditions in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • (1) Aged between 18 and 65 years; (2) Fulfilment of western medical diagnostic criteria for FD; (3) Meeting the diagnostic criteria for mild depression; (4) Comply with the diagnostic criteria of Liver and Stomach Depression and Heat Disorder in Chinese medicine; (5) A score of 7-17 on the 17-item Hamilton Depression Scale (HAMD-17) (7-17 being mild depression); (6) Good compliance and autonomous behaviour; (7) Enrolled patients must have a diagnosis of gastroscopy, and the gastroscopic diagnosis should be no abnormality or chronic gastritis, no obvious erosion can be seen under the microscope, and there is no obvious atrophy, intestinal epithelial metaplasia, or heterogeneous hyperplasia in the pathological examination. It should be based on the results of gastroscopy in a tertiary-level hospital within 6 months.
• Exclusion Criteria:
• • (1) HP-positive patients; (2) Dyspepsia caused by organic diseases of the digestive system, such as peptic ulcer, reflux oesophagitis, erosive gastritis (grade 2 or above), atrophic gastritis, gastrointestinal tract tumour, gastrointestinal haemorrhage, hepatic, gallbladder and pancreatic diseases, intestinal obstruction, inflammatory bowel disease, and so on; (3) Systemic diseases affecting the dynamics of the digestive tract, such as diabetes mellitus, chronic renal insufficiency, connective tissue disease, neurological lesions, etc; (4) Those with severe primary heart, brain, liver, lung, kidney, blood or serious diseases affecting their survival; (5) Those with depression, suicidal tendencies and mental disorders who cannot cooperate; (6) Pregnant and breastfeeding women, patients with recent birth plans; (7) Taking drugs that have an effect on the results of this study within 2 weeks before participating in this study; (8) Those who are allergic to or have adverse reactions to the drugs in this study.