functional dyspepsia
Conditions
Interventions
experimental group:tegoprazan
control group:placebo
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Outpatients aged 18-65 years;2) Patients meeting the diagnostic criteria of Rome ?FD: a. The diagnostic criteria for postprandial discomfort syndrome must include one or two of the following, at least 3 days per week: ? Postprandial fullness and discomfort (affecting daily activities);(2) early satiety discomfort (so that you can't eat the usual amount of food)Routine examination, including gastroscopy, found no evidence of organic, systemic or metabolic disease that could explain the above symptoms.Symptoms appeared at least 6 months before diagnosis, and above diagnostic criteria were met in the last 3 months.b.The diagnostic criteria for epigastric pain syndrome must include 1 or 2 of the following, and at least 1 day per week: ? Middle and epigastric pain (which interferes with daily activities);(2) Abdominal burning discomfort in the middle and upper abdomen (so that it affects daily activities).Routine examination, including gastroscopy, found no evidence of organic, systemic or metabolic disease that could explain the above symptoms.Symptoms appeared at least 6 months before diagnosis, and above diagnostic criteria were met in the last 3 months.3) The ability to stop taking medications that may interfere with the assessment of efficacy;4) Knowingly and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1) Gastroscopy revealed gastric cancer, peptic ulcer, erosive gastritis (grade 2 and above), moderate and severe atrophic gastritis, dysplasia or other organic diseases of the gastrointestinal tract;2) History of severe cardiopulmonary insufficiency, liver and kidney insufficiency, endocrine disorder, hematopoietic dysfunction;3) History of abdominal surgery (except appendectomy and cesarean section);4) Severe anxiety or depression (GAD-7 or PHQ-9=15 points);5) Pregnant or lactating women in the medical history;6) Allergic to the ingredients of the study drug or benzimidazoles;7) Taking azanavir, Nelfinavir, Ripiverine;8) Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7 point global overall symptom scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| routine blood test;gastrin;pepsinogen;Fecal flora;Pancreatic exocrine function;Bacterial overgrowth in the small intestine;Anxious state;Depressive state;renal function;liver function;electrolyte;Blood fat;blood sugar; | — |
Countries
China
Contacts
Public ContactLing Liu
West China Hospital, Sichuan University
Outcome results
None listed