functional dyspepsia (FD)
Conditions
Interventions
Placebo-controlled group:Sanjiu weitai granules placebo, 2.5g, bid
Experimental group:Sanjiu weitai granules placebo,2.5g,bid
Sponsors
Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 70 years old; 2. fulfill the diagnostic criteria of Functional dyspepsia in Rome III; 3. fulfill the diagnostic criteria of TCM syndrome patterns as follows:syndrome of dampnessheat of spleen and stomach,syndrome of incoordination beteeen liver and stomach,syndrome of intermingled heat and cold,syndrome of spleen-deficiency and qi-stagnation,syndrome of deficient cold of spleen and stomach; 4. sign the informed consent and will to accept corresponding intervention; 5. have the ability of reading power.
Exclusion criteria
Exclusion criteria: 1. merge with diseases of active peptic ulcer,gastritis with active bleeding or mucosal erosion,active inflammation or severe dysplasia by pathology; 2. Hp positive infection(any one of the tests positive:bacterial culture,histology,urea breath test,rapid urease test and stool antigen test); 3. patients of gastroesophageal reflux disease(typical symptoms of heartburn and reflux); 4. organic digestive diseases (such as chronic pancreatitis,cholecystitis,cholelithiasis,etc.), or with systemic diseases affect the digestive function (eg: diabetes, chronic renal insufficiency, connective tissue disease, mental and nervous system Disease,etc); 5. a stomach / abdominal surgery history (except for appendectomy); 6. have used treatment medicines of the disease in the nearly two weeks after the onset of the disease and do not allow entering a 2-week drug washout period because of the disease condition or individuals unwilling; 7. has a serious primary cardiovascular disease, liver disease, kidney disease, hematologic disease, lung disease, or other serious diseases affected the survival, such as cancer or AIDS; 8. mental illness and intellectual, language disabilities; 9. pregnant or lactating women; 10. be allergy to the drug composition used in the trial; 11. patients who is participating or participated in last 4 weeks in other drug clinical trials; 12. suspected or indeed alcohol or drug abuse history,or possibility of easily being lost according to the researchers' determination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of Patient reported outcome instrument;Functional Digestive Disorders QoL Questionnaire(FDDQL); | — |
Countries
China
Contacts
Public ContactXudong Tang
Outcome results
None listed