Functional Dyspepsia
Conditions
Interventions
control group:Mosapride Citrate Dispersible Tablets, 1 Tablets/per, tid+placebo, 2grain/per, bid
treatment group:Mosapride Citrate Dispersible Tablets, 1 Tablets/per, tid+shuganjieyujiaonang, 2 grain/per, bid
Sponsors
Shanghai Jiaotong University School of Medicine Renji Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) fulfill the diagnostic criteria of Functional dyspepsia in Rome III; (2) fulfill the diagnostic criteria of TCM syndrome patterns as Liver depression and spleen deficiency; (3) PHQ-9 score 5~14 or GAD-7 score 5~14; (4) Male and female aged 18 to 70 years old, no limit on the gender; (5) Nearly a year underwent endoscopy, Check the results were no obvious abnormalities or Chronic superficial gastritis, HP negative or HP eradication treatment within six months; (6) have the ability of reading power; (7) Voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Gastroscopy showed:Gastric and duodenal ulcer, Severe erosion, Active inflammation, Severe hyperplasia, tumor; (2) Past history of abdominal surgery (appendectomy and hernia repair except); (3) Within 2 weeks to use Other prokinetic drugs, Mucous membrane protective agent or Acid inhibitor,dredge the liver,Health the Spleen, Soothe the nerves; (4) Within 2 weeks to use Antidepressant,anxiolytics; (5) Combined with diabetes, Thyroid disease; (6) Combined with severity heart, lung, central nervous system, liver, gallbladder,pancreatic organic disease. Liver disease activity or liver dysfunction, ALT or AST>1.5MUNL, Kidney disease or renal insufficiency, SCr>1.3MUNL; (7) Severe mental disorder or Suicidal tendencies; (8) Alcohol, drugs or illicit drugs history; (9) be allergy to the trial drug,Allergic constitution; (10) lactating or pregnant women,Planning for pregnancy; (11) patients who is participating or participated in last 3 months in other drug clinical trials; (12) The researchers believe that patients are not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom curative effect after 6 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom curative effect after 2 weeks of treatment;Symptom curative effect after 4 weeks of treatment;Clinical symptom scores change after 2 weeks,4weeks,6weeks of treatment;PHQ-9scores change after 4weeks,6weeks of treatment;GAD-7 scores change after 4weeks,6weeks of treatmen;SF-36 scores change after 6weeks of treatmen; | — |
Countries
China
Contacts
Public ContactShengLiang Chen
Shanghai Jiaotong University School of Medicine Renji Hospital
Outcome results
None listed