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Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.
This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postprandial distress syndrome (PDS) | Other | FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS). pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. |
|
| epigastric pain syndrome (EPS) | Other | pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pCLE examination | Device | All FD patients received pCLE examination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCLE score | Used to assess the gastric barrier dysfunction of FD patients | within 1 hour after pCLE examination |
| Measure | Description | Time Frame |
|---|---|---|
| Leeds dyspepsia questionaire | Used to describe the change of severity of FD from baseline to the 4th week during the treatment | baseline and 4th week |
| Main dyspepsia symptom score | Used to describe the change of severity and frequency of despepsia symptoms from baseline to the 4th week during the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqing Li, MD.PhD. | Contact | 86-531-82169236 | 82169508 | liyanqing@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanqing Li | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009934 | Organization and Administration |
| ID | Term |
|---|---|
| D006298 | Health Services Administration |
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| Puyuanhewei | Drug | FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination. |
|
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| baseline and 4th weeks |