Hyperplasia of mammary gland
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for breast hyperplasia; 2. In line with the traditional Chinese medicine syndrome differentiation standards of liver stagnation, qi stagnation and spittoon coagulation and blood stasis; 3. Female aged 18 to 55 years(including 18 and 55); 4. Breast color ultrasound BI-RADS rating <=3; 5. Voluntarily participate in the clinical trial, give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Diseases requiring sex hormone therapy, such as dysfunctional uterine bleeding, amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactimia, etc.; 2. Complicated with heart, lung, brain, liver, kidney, hematopoietic system and other serious primary diseases, mental diseases; 3. ALT or AST is 1.5 times greater than the upper limit of the normal reference value, or Cr is greater than the upper limit of the normal reference value; 4. Menstrual period of more than 7 days, menopause, severe disorder of menstrual cycle; 5. Pregnant and lactating women who are not willing to take effective measures to prevent pregnancy during the trial and within 3 months after the end of the trial; 6. The contraceptive method is drug contraception; 7. Have a history of allergy to test drug ingredients; 8. A history of long-term alcohol and drug abuse; 9. having intellectual or mental retardation; 10. Participated in other clinical trials within the last 3 months; 11. The investigator did not consider it appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy test;Urinary routine;renal function;liver function;12-lead electrocardiogram;Routine blood test; | — |
Countries
China