Intractable functional dyspepsia
Conditions
Interventions
B:To be treated with routine drugs for 4 weeks
A:to be treated with both routine drugs and amitriptyline (12.5-37.5mg) during 4 weeks.
Sponsors
Guangzhou First Municipal People's Hospital,Guangzhou Nan Sha Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients from the gastroenterology outpatient of Nansha Center Hospital of Guangzhou First Municipal People's Hospital who conform to the Rome III criteria for functional dyspepsia (patients must have one or more of following symptoms for at least 3 months with symptom onset at least 6 months previously: bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning with no evidence of structural disease, including the use of upper endoscopy, which is likely to explain the symptoms); 2. In addition, patients were required to have continuous symptoms for at least 6 months that had unresponsive to at least 2 medical treatments, including acid treatment, proron pump inhibitors, prokinetics, and Helicobacter Pylori eradication therapy; 3. Gender not limited, age from 18 years to 65 years; 4. Willing to participate and give consent for participation in the study.
Exclusion criteria
Exclusion criteria: 1. Oesophagitis, peptic ulcer, erosion, cancer or other structural disease at endoscopy that was likely to explain the symptoms or with history of these disease; 2. Laboratory, B ultrasonic, X-ray examination have found liver, gall, Pancreas, Spleen and bowel organic disease; 3. Systemic disease, such as diabetes, connective tissue diseases and mental illness, etc; 4. History of abdominal surgery; 5. Aged 18 years to 65 years; 6. Pregnancy or breast feeding; 7. Disabled patients; 8. patients is Concurrently undergoing other drugs in clinical research or nearly half a month used the Similar drugs; 9. In a severe anxiety or depression state, or suicidal tendencies; 10. Contraindications or careful with amitriptyline, including: hypersensitivity;with history of serious cardiovascular disease, Severe hypertension; liver dysfunction or renal Failure; dysuria or urinary retention; glaucoma; hyperthyreosis; seizures or seizures tendency, prostatitis, cystitis patients; bronchus asthma patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A questionnaire of digestive tract symptoms;Hamilton Depression Rating Scale 17-item (HAMD-17);Hamilton Anxiety Rating Scale(HAMA);The Pittsburgher Sleep Quality Index(PSQI);Short Form Nepean Dyspepsia index;Clinical Global Impression, CGI;Side effects;Gastrointestinal hormone;Inflammatory factor;Behaviour;Gastric sensitivity;Gastric emptying;Accommodation of the proximal stomach;Cost-effectivenes; | — |
Countries
China
Contacts
Public ContactLin Jia
Outcome results
None listed