postprandial distress syndrome
Conditions
Interventions
control group:Take Simo decoction placebo
Sponsors
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria 1.Meet the diagnostic criteria for IV of PDS 2.Age between 18-65 years (including endpoint values) 3.The subject was informed and voluntarily signed the informed consent form; 4.Have a certain reading ability. Grouping criteria 1.Subjects continued to be willing to participate in this study; 2.The days with a VAS score exceeding 4 for the main symptoms (at least one symptom of postprandial fullness discomfort and morning satiety) exceeded 3 days.
Exclusion criteria
Exclusion criteria: 1.Combined with gastric and duodenal ulcers, see mucosal erosion and blood infiltration under gastroscopy, pathological examination suggests gastric mucosal atrophy, intestinal differentiation or hyperplasia; 2.Hp infection was positive (bacterial culture, histological examination, urea breath test, rapid urease test and fecal resistance , One diagnosis of the original test was positive); 3.Patients with gastroesophageal reflux disease (typical heartburn and reflux symptoms) 4.There are organic lesions of the digestive system (such as chronic pancreatitis, etc.), or systemic diseases that affect the digestive tract dynamics (for example: diabetes, chronic renal dysfunction, connective tissue disease, psychiatric and neurological lesions,etc.); 5.History of gastric / abdominal surgery (except caesarean section, appendectomy) 6.Traditional Chinese and western medicine treatment drugs (such as: gastric motility drugs and antibile) have been used within nearly 2 weeks after this disease Alkalinergic drugs, proton pump inhibitors, H2 receptor antagonists, etc.); 7.With severe primary cardiovascular lesions, liver lesions (ALT> 1.5 times normal, and / or AST> 1.5 times normal), renal lesions, hematological lesions, lung disease, or serious diseases affecting their survival, such as tumor or AIDS; 8.Psychisis and those with intellectual and language disorders; 9.Women during pregnancy or lactation; 10.allergic constitution or allergic to the drug composition of this preparation; 11.Participating in other drug clinical trials in or within 4 weeks; 12.Long-term sedative and hypnotic drugs (medication> 3 times a week), antidepressants, and opiate preparations; 13.Suspected or real history of alcohol or substance abuse; or judged by the researchers to reduce the probability of enrollment Or complicate the group, such as frequent working environment changes, prone to loss of visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| functional digestive disorder quality of life questionnaire;Hospital Anxiety depression Scale score;Evaluation of individual symptoms of postprandial distress syndrome;overall Treatment Evaluation scale; | — |
Countries
China
Contacts
Public ContactXudong Tang
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine Sciences
Outcome results
None listed