Functional Dyspepsia
Conditions
Interventions
Treatment Group:Jiawei Xiaoyao Wan
Sponsors
Dongzhimen Hospital Beijing Univercity of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the western medicine diagnostic criteria for functional dyspepsia. 2. At lest one of the four clinical symptoms of modified GIS (postprandial fullness discomfort, premature discomfort, middle and upper abdominal pain, middle and upper abdominal burning discomfort, etc.) was more than 1. 3. Meet the liver depression and spleen deficiency TCM syndrome. 4. 7<HAMD17=17. 5. 18=age=75, male and female. 6. Volunteer and already signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Combined with peptic ulcer, hemorrhage, atrophic gastritis, erosive gastritis or other gastric organic diseases. 2. Combine other organic diseases that cause indigestion, such as cholecystitis and pancreatitis,, etc. 3. Indigestion caused by taking aspirin or other NSAIDs and any other drugs. 4. Abdominal surgery history (except for appendectomy and hernia repair). 5. Depreesion was more than 3 or suiside was more than 2 in HAMD17. 6. Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system, ALT, AST > 1.5 times the upper limit of normal, Cr > normal upper limit. 7. Patients with menopausal syndrome, malignant tumors. 8. Those who have had a history of mental illness or who have not been diagnosed but have systematically used anti-anxiety, anti-depression and other psychotropic drugs in the past two weeks. 9. Patients that can not express subjective discomefort symptoms. 10. Pregnant, lactating women or those who have a birth plan during the trial. 11. In a week before enrollment, those who had systematically taken acid-suppressing drugs (such as PPI, H2 receptor blockers), gastrointestinal motility drugs (such as cisapride, domperidone), gastric fundus drugs (such as 5-HT1A agonists, Tandospirone, acotamine), anti-Helicobacter pylori drugs. 12. Patients that allergic to the test drug composition. 13. Participated in other drug clinical trials within 3 months. 14. Patents that researchers believe not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified GIS total score change at the fourth weekend; | — |
Secondary
| Measure | Time frame |
|---|---|
| modified GIS total score change at the second,sixth,eighth weekends;HAMD17 total score change at the second,fourth,sixth weekends;Twelfth item score change of HAMD17 at the second,fourth,sixth weekends;HAMA score change at the second,fourth,sixth weekends;TCM syndrome score change at the second,fourth,sixth weekends;TCM Single symptom score change at the second,fourth,sixth weekends;Recurrence rate of FD at the sixth, eighth weekends; | — |
Countries
China
Contacts
Public ContactHongkai Li
Outcome results
None listed