Functional Dyspepsia
Conditions
Interventions
Qizhi Weitong Group:Subject acceptted Qizhi Weitong
Control Group:The subjects were treated with imitation of Qizhi Weitong granules
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 20 to 65 years male or female; 2. meet the Rome III standard FD-PDS subtype (see Appendix 3), and at least 6 months before the screening of the following 1 or more than 1 symptoms: postprandial satiety, early satiety of the subjects; 3. before screening within 3 months following the 2 or 2 or more symptoms and achieve moderate or severe level: upper abdominal pain, abdominal discomfort, postprandial fullness, epigastric fullness, early satiety, nausea, vomiting or belching (of which 1 were postprandial fullness or early satiety) the subjects; 4. the most painful symptoms are one of the following symptoms: postprandial fullness, abdominal fullness or early satiety, coexistence of epigastric pain syndrome symptoms (upper abdominal pain, upper abdominal burning) patients can also enter the group; 5. when informed consent was obtained, the subjects still had the symptoms of postprandial fullness, epigastric fullness or early satiety; 6. voluntary acceptance of the test drug, and signed informed consent. The informed consent process conforms to the relevant regulations of GCP.
Exclusion criteria
Exclusion criteria: 1. the upper gastrointestinal endoscopy, esophageal, any organic lesion (duodenal and gastric ulcers, gastroesophageal reflux disease, gastrointestinal bleeding, mechanical obstruction, hiatal hernia or Barrett's disease) of the subjects; 2. 15 days before the study of continuous use of Chinese and Western medicine treatment of drugs associated with the disease or effect of anticholinergic drugs in this study (such as tiquizium bromide, scopolamine Butylbromide, thiotepa bromide) or with muscle relaxant drugs (such as diazepam, chlorzoxazone, etc.); 3. with some patients cannot deactivate anticholinergic drugs (such as tiquizium bromide, scopolamine Butylbromide, thiotepa bromide) or with muscle relaxant drugs (such as diazepam, chlorzoxazone, etc.); 4. the history of abdominal surgery (excluding appendectomy, caesarean section, ligation) 5. Subjects with irritable bowel syndrome; 6. subjects with biliary tract diseases (cholangitis, gallstones, etc.) and / or pancreatitis (including chronic pancreatitis); 7. Patients with endocrine and metabolic diseases, such as connective tissue diseases and diabetes mellitus, were enrolled; 8. patients with serious cardiovascular and cerebrovascular system, blood, lung disease or malignant tumor; nervous system disease, including mental illness history or family history of mental disorders (especially depression and anxiety, depression etc.); 9. the liver (AST and ALT is greater than the normal value of 1.5 times the upper limit), kidney disease (blood creatinine is greater than the normal limit) patients; 10. drug or alcohol abuse subjects; 11. subjects who have severe allergies or who have used test drugs and are allergic to their components; 12. During the study, it was necessary to take anti secretory drugs, antacids, gastric motility drugs, NSAIDs, or antidepressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood test;urine test;Liver and kidney function test;QOL score; | — |
Countries
China
Contacts
Public ContactZhao Wei
Tianjin Medical University General Hospital
Outcome results
None listed