functional dyspepsia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Rome IV diagnostic criteria for functional dyspepsia are adopted. 2. Patients with one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning (with or without epigastric bloating, belching, and nausea), and without evidence of organic, systemic or metabolic diseases found in routine examination and endoscopic examination which could explain the symptoms, will be included in this study. 3. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. 4. If the above symptoms are relieved by evacuation of feces or gas, they should generally not be considered as functional dyspepsia. Patients are eligible for this study whether they have previously used prokinetic drugs (such as, domperidone, mosapride, itopride, and sinipride, etc.) or not.
Exclusion criteria
Exclusion criteria: 1. Patients with mental and language disorders; 2. Patients who are allergic to prokinetic drugs or their components; 3. Patients who have gastrointestinal alarm symptoms: unexplained weight loss, repeated vomiting, progressive dysphagia, hematemesis, melena, etc.; 4. Helicobacter pylori associated dyspepsia (positive results for Helicobacter pylori test, or less than 12 months after Helicobacter pylori eradication; dyspepsia caused by NSAIDs or other drugs; 5. Other serious organic, systemic or metabolic diseases; 6. Other situations that may add difficulties to enrollment or follow-up, such as frequent changes in the working places.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall effective rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of single symptom;Overall symptom score;Single symptom score;Treatment response rate;Symptom relief rate; | — |
Countries
China
Contacts
Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology