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This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qizhi Weitong Granules Group | Experimental | Patients in this group will take Qizhi Weitong Granules for 8 weeks. |
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| Mosapride Citrate Tablets Group | Active Comparator | Patients in this group will take mosapride citrate tablets for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qizhi Weitong Granules | Drug | Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Main Symptom Score | The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on. | The score will be assessed at baseline and 2 week, 4 week, 6 week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale | To evaluate the changes of patients' mental and psychological status | The score will be assessed at baseline and 2 week, 4 week, 6 week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang F yun, PhD | Contact | 13522657731 | 0086 | wfy811@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Tang X dong, PhD | Director of Xiyuan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuan Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100091 | China |
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| ID | Term |
|---|---|
| C062720 | mosapride |
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| Mosapride Citrate Tablets | Drug | Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks. |
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