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To evaluate the symptom improvement of Zuojinwan combined with rabeprazole or Zuojinwan combined with a mosapride regimen in patients with functional dyspepsia combined with depression (liver-stomach depression-heat type) using rabeprazole or mosapride regimen as a control, and to compare the patients' adherence to the medication and the adverse effects between the two groups.
Functional dyspepsia (FD) is the highest incidence of functional gastrointestinal disorders (FGIDs), of which the prevalence of FD combined with depression is 16.4%~22.8%, FD etiology is complex and diverse, and in the "Functional Gastrointestinal Disease Rome IV Diagnostic Criteria" released in 2016, it is clearly proposed that its nature is "brain-gut interaction disorder". The "Rome IV Diagnostic Criteria for Functional Gastrointestinal Diseases" released in 2016 explicitly proposed that its essence is "brain-gut interaction disorder", and it is due to the bidirectional regulation of the brain-gut axis that the phenomenon of combined depression is common in FD patients induced by "brain-gut interaction disorder", which is prone to clinical underdiagnosis and misdiagnosis, and also to clinical depression. It is easy to cause clinical underdiagnosis and misdiagnosis, and also brings many challenges to drug treatment. It is feasible to use Zuojinwan combined with rabeprazole sodium enteric-coated capsules or Zuojinwan combined with mosapride citrate tablets for the treatment of FD combined with depression. The aim of this study is to compare the efficacy of Zuojinwan combined with rabeprazole sodium enteric-coated capsules or mosapride citrate for the treatment of FD combined with depression with that of rabeprazole sodium enteric-coated capsules or mosapride citrate treatment alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rabeprazole sodium enteric-coated tablets or mosapride citrate | Experimental | For epigastric pain syndrome, Rabeprazole sodium enteric-coated tablets were given as 20mg/dose, 2 times/day. Postprandial discomfort syndrome was treated with mosapride citrate, 5mg/dose, 3 times/day, orally before meals. The treatment lasted for 4 weeks. |
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| Chinese medicine combination group | Experimental | In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zuojinwan | Drug | In the Chinese medicine combination group, 3g of Zuojinwan was added to the western medicine group twice a day for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressionsymptom scale | Hamilton Depression Scale is assessed patients' depressive symptoms pre- and post-treatment. | Pre-treatment and 4 weeks of treatment |
| FD symptom scale | The overall score method for the main symptoms was used, and the overall symptoms included postprandial fullness and discomfort, early satiety, mid-upper abdominal pain, and burning sensation in the mid-upper abdomen. The degree and frequency of symptoms were observed before and after treatment | Pre-treatment and 4 weeks of treatment |
| Chinese Medicine Symptoms | Evaluation of Chinese medicine symptoms before and after treatment using the Chinese Medicine Symptoms Score Scale | Pre-treatment and 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events during treatment | Ask patients about the occurrence of adverse events during treatment | Pre-treatment and 4 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yan wang | Contact | 19801295220 | 292615568@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| wanli liu | The First Affiliated Hospital with Nanjing Medical University | Study Director |
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| Rabeprazole sodium enteric-coated tablets | Drug | For epigastric pain syndrome |
|
| mosapride citrate | Drug | Postprandial discomfort syndrome |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C062720 | mosapride |
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