Functional dyspepsia
Conditions
Interventions
Treatment group: Jieyu Dawei Formula
Control group:Placebo
Sponsors
Dongfang Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western diagnostic criteria for functional dyspepsia postprandial discomfort syndrome; (2) Meets the diagnosis of mild anxiety and/or mild depression i.e. 50 = SAS = 59 points and/or 53 = SAS = 62 points; (3) Meets the traditional Chinese medicine diagnostic criteria for liver stomach disharmony syndrome; (4) Age between 18 and 80 years old; (5) Voluntarily participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Digestive disorders caused by organic diseases of the digestive system such as peptic ulcers reflux esophagitis erosive gastritis atrophic gastritis gastrointestinal tumors gastrointestinal bleeding hepatobiliary and pancreatic diseases gastroparesis intestinal obstruction inflammatory bowel disease etc; (2) Individuals who test positive for Hp or are undergoing quadruple therapy to eradicate HP; (3) Individuals with progressive dysphagia persistent vomiting and unconscious weight loss; (4) Individuals with a history of gastrointestinal surgery (excluding appendectomy); (5) Individuals with immune dysfunction (such as leukemia cancer patients etc.) or those who have used immunosuppressants or glucocorticoids in the past 3 months; (6) Patients with severe heart failure liver (ALT/AST exceeding 1.5 times the upper limit of normal) kidney function (blood creatinine exceeding 1.5 times the upper limit of normal) and hematopoietic system abnormalities; (7) Individuals with severe primary heart brain liver lung kidney blood or serious diseases that affect their survival; (8) Disabled patients as defined by law (blind deaf mute intellectually disabled mentally disabled physically disabled); (9) Pregnant (women of childbearing age who test positive for pregnancy) or lactating women and patients who have recently planned to have children; (10) Individuals who are allergic to the components of this medication; (11) Individuals who have participated in or are currently participating in clinical trials of other drugs in the past 3 months or whose medication may have an impact on the efficacy evaluation of the investigational drug; (12) Suspecting or having a history of alcohol or drug abuse or taking drugs that may affect the effectiveness evaluation of the investigational drug (such as acid suppressants/antacids nonsteroidal anti-inflammatory drugs anticholinergic drugs glucocorticoids antidepressants etc.); (13) Researchers believe that participants are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of severity of main symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Score;Functional dyspepsia quality of life score;Single symptom efficacy;SAS Self Rating Scale Score;Dosage of Mosapride tablets;SDS Self Rating Scale Score; | — |
Countries
China
Contacts
Public ContactShi Lei
Dongfang Hospital Beijing University of Chinese Medicine
Outcome results
None listed