Functional Dyspepsia
Conditions
Interventions
treatment group:QI ZHI WEI TONG granula and Simulation of? mosapride citrate tablets
control group:mosapride citrate tablets and Simulation of QI ZHI WEI TONG granula
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Science
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Screening criteria: (1) meet the diagnostic criteria of Roman IV for functional dyspepsia; (2) between the ages of 18 and 65 years; (3) the subject is informed and voluntarily signed the informed consent; (4) have certain reading ability. Criteria for treatment: (1) subjects will continue to participate in this study; (2) after the screening period, the score of the symptom score at least one symptom (degree + frequency) is still greater than 4, and the reduction rate is less than 50%.
Exclusion criteria
Exclusion criteria: Screening and exclusion criteria: (1) combined with gastric and duodenal ulcer, the mucosal erosion and blood seepage were seen in the gastroscope, and the pathological examination indicated gastric mucosal atrophy, intestinal metaplasia or atypia. (2) positive Hp infection (bacterial culture, histological examination, urea exhalation test, rapid urease test and stool antigen test); (3) patients with gastroesophageal reflux disease (typical heartburn and reflux symptoms); (4) have a digestive system organic lesion such as chronic pancreatitis, etc.), or there would affect the dynamics of the digestive tract diseases (such as diabetes, chronic renal insufficiency, connective tissue disease, mental and neurological diseases, etc.); (5) patients with gastric/abdominal surgery (except appendectomy); (6) in the last two weeks after the onset of this disease, we have used Chinese and western medicine (e.g., gastric power medicine, anticholinergic drug, proton pump inhibitor, H2 receptor antagonist, etc.) related to the disease; (7) with severe primary cardiovascular disease, liver disease (ALT > normal 1.5 times, 1.5 times and/or AST > normal), kidney disease, hematologic disease, lung disease, or seriously affect the survival of the disease, such as cancer or AIDS; (8) mentally ill and mentally disabled; (9) pregnant or lactating women; (10) allergic constitution or an allergy to the pharmaceutical composition of this preparation; (11) patients who are participating in clinical trials of other drugs within or four weeks; (12) patients with long-term sedative and hypnotic drugs (> three times a week), antidepressants and opiates; (13) doubt or have alcohol and drug abuse history, or according to the researcher's judgment, have lower possibility into the group or complicate the into the group of other conditions, such as working environment change often easy to cause lost to follow-up. Elimination criteria for treatment period: (1) ALT and AST are 1.5 times higher than normal;Crea is beyond the normal range; (2) 1.5 times the total bilirubin exceeded the normal limit; (3) abnormal ecg patients with arrhythmia or abnormal Q wave or QT interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom rating scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome differentiation change;Hamilton anxiety scale;Hamilton depression scale; | — |
Countries
China
Contacts
Public ContactTang Xu Dong
Xiyuan Hospital of China Academy of Chinese Medical Science
Outcome results
None listed