Functional dyspepsia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18-65 years; 2. Meet the diagnostic criteria for functional dyspepsia; 3. In line with TCM syndrome of liver depression and spleen deficiency; 4. The frequency of symptoms of functional dyspepsia and the severity of symptoms are grade II or higher; 5. The patients voluntarily participated in this study, signed the written informed consent, and were willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have received functional dyspepsia drugs or acupuncture within 2 weeks before screening; 2. Patients who have undergone any surgery within 2 weeks before the screening examination; 3. Patients with diabetes, coagulation disorders or severe skin diseases; 4. During the screening examination, the alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of the patient is greater than or equal to 1.5 times the upper limit of the normal value specified by the center, or the endogenous creatinine clearance (CCr) is greater than the upper limit of normal specified by the center; 5. During the screening examination, the total number of white blood cells (WBC) in the patient's blood routine is greater than 10.0X10^9/L or less than 1.0X10^9/L; 6. The patient has a history of immunodeficiency diseases (such as HIV, etc.), or a history of cancer, malignant tumor, or autoimmune disease, or serious cardiovascular or cerebrovascular diseases, or other diseases that may significantly reduce life expectancy; 7. Have any history of diseases that may affect compliance with the program (such as severe mental disorders, cognitive dysfunction, drug abuse or addiction, etc.); 8. Pregnant or breastfeeding patients, or those who are fertile and unwilling/unable to take effective contraceptive measures; 9. Those who are known to be allergic to the ingredients contained in the research drug; 10. Those who have participated in any drug clinical trials within 6 months before the screening examination; 11. Patients who are judged by the investigator to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effective rate;Overall symptom score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Motilin;5-hydroxytryptamine; | — |
Countries
China
Contacts
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine