Functional dyspepsia postprandial discomfort syndrome
Conditions
Interventions
Test group:Yangwei Granules, 6 g/bag each time, 3 times a day.
control group:Yangwei Granule Simulator, 6 g/bag each time, 3 times a day.
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of postprandial discomfort syndrome of functional dyspepsia in modern medicine; (2) Conforming to the TCM standard of spleen deficiency qi stagnation syndrome differentiation; (3) between the ages of 18 and 70 (including 18 and 70 years of age), male or female; (4) 5-point Likert scores of main symptoms (at least one symptom in postpranpranal fullness and discomfort and early satiety) during the one-week introduction period: degree score =2 points, frequency =3 days/week; (5) Outpatient patients; (6) Women should meet the following conditions to be enrolled: there is no possibility of pregnancy; There is a possibility of pregnancy, but the pregnancy test was negative at baseline, and they agree to use non-drug complete contraception during the study period and continue to use contraception for at least 3 months after completion of the study or early termination of the study; (7) The subject is informed and voluntarily signs the informed consent.
Exclusion criteria
Exclusion criteria: (1) Gastric mucosal dysplasia (intraepithelial neoplasia), severe intestinal metaplasia, peptic ulcer, gastric mucosal erosion (grade 2 or above), bile reflux, duodenoculitis, and moderate to severe active inflammation of gastric mucosa were diagnosed by gastroscopy combined with histopathology; (2) Severe antrum atrophy, chronic atrophic gastritis of C2 and above in Kimura-Takemoto classification; (3) Patients with hiatal hernia or (and) reflux esophagitis; (4) Patients with organic diseases of stomach and duodenum; (5) The anxiety or depression score measured by the hospital anxiety and depression scale =11 points; (6) Hp infected persons; (7) Patients with a history of abdominal surgery (except appendectomy without complications, caesarean section and endoscopic gastrectomy of gastric polyps); (8) Those who could not stop using the prohibited drugs prescribed in this study after enrollment; (9) Immune dysfunction (such as leukemia, tumor patients, etc.), or use of immunosuppressants or glucocorticoids within the past 3 months; (10) Severe heart and lung insufficiency, ALT/AST=1.5 ULN, BUN/CR > 1 ULN, diabetes, thyroid dysfunction and other endocrine system diseases; Abnormal hematopoietic system, hematological examination indicated the presence of iron deficiency anemia; (11) Chemical dyspepsia caused by cholecystitis, cholelithiasis and chronic pancreatitis; (12) Complete autonomous defecation less than 3 times per week; (13) Mental patients and persons with intellectual or language disabilities who are unable to fill out scales or record their symptoms; (14) Those who are known to be allergic to the pharmaceutical components of this preparation; (15) Suspected or have a history of alcohol or drug abuse; (16) Participants who have participated in other clinical trials in the past 1 month; (17) Other circumstances in which the investigator deems it inappropriate to participate in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of improvement of two major single symptoms of postprandial fullness and early satiety (4 weeks of treatment); | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of improvement of two major single symptoms of postprandial fullness and early satiety (2 weeks of treatment and 2 weeks of follow-up) ;Dyspepsia symptom score;Nipin dyspepsia life quality index;Spleen deficiency qi stagnation syndrome integral; | — |
Countries
China
Contacts
Public ContactTang Xudong
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed