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To evaluate the improvement of symptoms in patients with gastroesophageal reflux disease combined with depression (hepatic and gastric depression-heat type) by Zuojin Wan combined with vornodine fumarate regimen as a control, and to compare the adherence to the medication and the adverse reactions of the patients between the two groups.
Gastroesophageal reflux disease (GERD) is a common digestive disorder, and in recent years studies have shown an increasing incidence of comorbid depression in patients with GERD. The treatment of gastric acid inhibition and mucosal protection alone is not effective for patients with reflux combined with depression, and the additional administration of neuromodulatory drugs will increase the incidence of adverse reactions, so the combination of traditional Chinese medicine may be one of the effective ways to solve the above problems. The aim of this study was to compare the efficacy of Zuojin Wan combined with vunorasan fumarate with that of vunorasan fumarate alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vonorasan fumarate | Experimental | Vonorasan fumarate, 20 mg twice daily orally before meals for 8 weeks of treatment. |
|
| Zuojin Pills combined with Vonorasan Fumarate | Experimental | Add Zuojin Pills, 3g each time, twice daily, on top of Vonorasan Fumarate treatment for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonorasan Fumarate | Drug | Vonorasan fumarate is taken 30min before breakfast and dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reflux Disease Questionnaire | According to the frequency and severity of episodes of the main symptoms,observe the changes of reflux'disease questionnaire score before treatment and after 8 weeks of treatment. | Baseline and 8 weeks |
| Hamilton Depression Scale | Assessing patients for depressive symptoms | Baseline and 8 weeks |
| Chinese Medicine Points Scale | Assessment of TCM evidence before and after treatment | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events during treatment | Ask the patient about the occurrence of adverse events while taking the medication | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yan wang | Contact | 19801295220 | 292615568@qq.com | |
| wanli liu | Contact |
| Name | Affiliation | Role |
|---|---|---|
| wanli liu | The First Affiliated Hospital with Nanjing Medical University | Study Director |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D003863 | Depression |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Zuojin Pills | Drug | Zuojin Pills should be taken 30min after breakfast and dinner. |
|
| D004066 | Digestive System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |