Functional dyspepsia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age between 18-65 years old; 2) Accord with the diagnostic criteria of functional dyspepsia; 3) Accord with the syndrome of liver depression and spleen deficiency in traditional Chinese medicine; 4) The frequency and severity of symptoms of functional dyspepsia were above grade II; 5) Patients volunteered to participate in the study, signed informed consent and were willing to cooperate with the study.
Exclusion criteria
Exclusion criteria: 1) Patients who had received functional dyspepsia drugs or acupuncture treatment within 2 weeks before screening; 2) Patients who underwent any surgery within 2 weeks before screening; 3) Patients with diabetes, coagulation disorders or severe skin diseases 4) During screening examination, the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of the patient is greater than or equal to 1.5 times of the upper limit of normal value specified by the center, or the endogenous creatinine clearance (CCR) is greater than the upper limit of normal value specified by the center; 5) During screening examination, the total white blood cell count (WBC) of patients is greater than 10.0x109/l or less than 1.0x109/l; 6) The patient has a history of immune deficiency diseases (such as HIV), or a history of cancer, malignant tumor, or autoimmune diseases, or serious cardiovascular and cerebrovascular diseases, or other diseases that may significantly reduce life expectancy; 7) Have any history of diseases that may affect program compliance (such as severe mental disorders, cognitive impairment, drug abuse or addiction); 8) Pregnant or lactating women, or those who are unwilling / unable to take effective contraceptives; 9) Those who are known to be allergic to the ingredients contained in the drug used in this study; 10) Those who have participated in any drug clinical trial within 6 months before screening examination; 11) The investigator judged that patients should not participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate;Overall symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-hydroxytryptamine;Motilin; | — |
Countries
China