Healthy volunteers
Conditions
Interventions
A:Amitriptyline at 12.5mg p.o. three times each day for continous 7 days,followed by 14-day washout interval,then with placebo at 12.5mg p.o. three times each day for continuous 7 day
B:Placebo at 12.5mg p.o. three times each day for continuous 7 days, followed by 14-day washout interval,then with Amitriptyline at 12.5mg p.o. three times each day for continous 7 days
Sponsors
Guangzhou First Municipal People's Hospital,Guangzhou Nan Sha Center Hospital Affiliated to Guangzhou Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female Chinese healthy volunteers; 2. Aged 18 to 65 years old; 3. Body mass index between 19-24kg/m2; 4. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, chest x-ray examination, and 12-lead electrocardiogram (ECG); 5. Without depression and anxiety disease assessed by Hamilton Depression Scale(HAMD)and Hamilton Anxiety Scale(HAMA); 6. Without functional dyspepsia and irritable bowel disease assessed by Rome III Adult functional gastrointestinal disorders diagnostic questionaire; 7. Informed consent was obtained from all healthy volunteers.
Exclusion criteria
Exclusion criteria: 1. History of gastrointestinal surgery; 2. History of serious cardiovascular disease,pulmonary disease,renal diease,hepatical diease and gut disease; 3. Pregnancy or breast feeding; 4. Use of medications that may affect gastrointestinal motor function and the effect of amitriptyline; 5. History of gut disease or other disease that may affect gut motility; 6. Contraindications to amitriptyline, include hypersensitivity or allergy to any tricyclic drug, concomitant therapy with a monoamine oxidase inhibitor, recent myocardial infarction, myelography within previous 48 hours, history of urinary retention, known glaucoma, history of seizures, or thyroid or liver dysfunction are exclusionary criteria to the use of amitriptyline and to entry into this study; 7. Have participated in other clinical trial during last two weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| orocecal transit time;gastric emptying;accommodation of the proximal stomach;gastric sensitivity;inflammatory cytokines;gut hormon;A questionnaire of side effects;eating behavior;exercise behavior; | — |
Countries
China
Contacts
Public ContactLin Jia
Outcome results
None listed