functional dyspepsia
Conditions
Interventions
treatment group:Debitai
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Outpatients aged 18-65, male and female; (2) Meeting the diagnostic criteria for functional dyspepsia of Rome IV Functional Gastroenteropathy (2016 edition); (3) Postprandial distension discomfort, early satiety discomfort, middle and upper abdominal pain, and middle and upper abdominal burning discomfort, with at least one score (degree + frequency) >=4; Total score >=10; (4) Agree to participate in the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Suffering from thyroid disease, systemic sclerosis, systemic lupus erythematosus, chronic cholecystitis, gallstones and other serious hepatobiliary and pancreatic diseases; Or consider the possibility of intestinal obstruction; (2) Patients with organic gastrointestinal diseases such as reflux esophagitis, peptic ulcer, gastrointestinal tumor, etc.; (3) had used drugs affecting gastrointestinal motility or gastric acid secretion, neutralizing gastric acid, and anti-Helicobacter pylori drugs within 1 week before enrollment; (4) ALT and AST were 1.5 times higher than the normal value, total bilirubin was 1.5 times higher than the upper limit of the normal value, and creatinine was above the upper limit of the normal value; (5) Suspected or clear history of drug and alcohol abuse; (6) Patients with diabetes mellitus, epilepsy, and cognitive language disorders; (7) Acupuncture, qigong and other non-drug treatment; (8) pregnant women, lactating women or those planning to become pregnant; (9) Allergic to derbetyl and its components; (10) Patients with clinically significant arrhythmia, abnormal Q wave, QT interval prolongation and other abnormal ECG; (11) Those who have participated in other clinical trials and used drugs in the past 3 months; (12) Those who were not considered suitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of main symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total clinical effective rate;Single symptom score change value; | — |
Countries
China
Contacts
Public ContactZhaoshen Li
Shanghai Changhai Hospital
Outcome results
None listed