Functional dyspepsia (hepatic and gastric discord syndrome)
Conditions
Interventions
Positive drug group:Mosapride Citrate Tablets (1 tablet/time 3 times/day) Gastric Su granules simulant (1 bag/time 3 times/day) treatment for 4 weeks
Placebo group:Gastric Su granule simulant (1 bag/time 3 times/day) Mosapride citrate tablets simulant (1 tablet/time 3 times/day) treatment for 4 weeks
Experimental group:Gastric Su granules (1 bag/time 3 times/day) Mosapride citrate tablets simulant (1 tablet/time 3 times/day) treatment for 4 weeks
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Rome IV. functional dyspepsia postprandial discomfort syndrome; (2) Meet the TCM criteria for syndrome differentiation of liver and stomach discord; (3) Aged between 18 and 65 years old (including 18 and 65 years old) male or female; (4) 5-point Likert score for the main symptoms (at least one symptom of postprandial fullness and early satiety) in one week: degree score = 2 points and frequency =3 days/week; (5) Females should meet the requirements of no possibility of pregnancy or have the possibility of pregnancy but the pregnancy test is negative at the baseline examination and both men and women must agree to use non-drug complete contraception during the study period (referring to non-drug-dependent contraception such as intrauterine device use of condoms vaginal diaphragm cervical cap and other barrier contraceptive methods) and adhere to contraception for at least 3 months for a period of time after completing the study or early termination of the study; Subjects are informed and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with gastric mucosal dysplasia (intraepithelial neoplasia) severe intestinal metaplasia peptic ulcer gastric mucosal erosion (grade 2 or above) bile reflux duodenal cocloccitis and moderate to severe active inflammation of the gastric mucosa combined with pathological histology; (2) Patients with severe antral atrophy chronic atrophic gastritis of Kimura-Takemoto classification C2 and above or patients with hiatal hernia ornia and/or reflux esophagitis or patients with organic lesions of the stomach and duodenum; (3) The Hospital Anxiety and Depression Scale (HADS) measured anxiety or depression score = 11 points; (4) HP infected people; (5) Those who have a history of abdominal surgery within three years (except for uncomplicated appendix surgery caesarean section and endoscopic gastrointestinal polypectomy); (6) Those who cannot stop the prohibited drugs specified in this study after enrollment; (7) Immunodeficiency (such as leukemia tumor patients etc.) or the use of immunosuppressants or glucocorticoids in the past 3 months; (8) Patients with severe cardiac function (such as atrioventricular block and severe arrhythmia) pulmonary insufficiency ALT or AST =1.5 ULN BUN or Scr>1 ULN diabetes thyroid dysfunction and other endocrine system diseases; Patients with abnormal hematopoietic system and those with severe anemia (Hb<60g/L) found by blood examination; (9) Chemical dyspepsia caused by cholecystitis gallstones chronic pancreatitis etc.; (10) The number of completely spontaneous bowel movements is less than 3 times per week; (11) Mentally ill patients (such as those who have been diagnosed with anxiety and depression and are taking medication) and those with intellectual or language impairments that make them unable to fill in the scale or record their own symptoms; (12) Those who are known to be allergic to the components of the drug of this preparation; (13) Suspected or confirmed history of alcohol and drug abuse; (14) Those who have participated in other clinical trials in the past 3 months; (15) Those who need to continuously take non-steroidal anti-inflammatory drugs and other drugs that damage or irritate the gastric mucosa during the test; Other conditions that are considered inappropriate by the investigator to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of improvement in the total score of the two main symptoms of postprandial fullness and discomfort ; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Pattern Score;Response rate of improvement in the total score of the two main symptoms of postprandial fullness and discomfort ;Overall disease efficacy evaluation ;Recurrence rate;PDS single symptom score and response rate ;Niping dyspepsia quality of life index; | — |
Countries
China
Contacts
Public ContactTang Xudong
Medical Ethics Committee Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed