Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands

Inclusion Criteria:

1. Female patients aged 18 to 50 (including boundary values);

2. Those who meet the diagnostic criteria for breast hyperplasia in Western medicineand have a disease course of more than 3 months;

3. Meets the traditional Chinese medicine differentiation criteria for liver depressionand phlegm coagulation syndrome;

4. The BI-RADS grading of the target side breast ultrasound is 2-3 levels, while theBI-RADS grading of the non target side breast ultrasound is 1-3 levels;

5. During the screening period, the NRS score is ≥ 4 and there is a target massdetected by palpation;

6. During the introduction period, the average NRS score within the day of paininvolvement is ≥ 4 points, and there is still the presence of the target mass onpalpation;

7. During the import period, the number of days with pain involvement in the menstrualcycle is greater than 7 days;

8. With informed consent, voluntarily participate in the experiment and sign theinformed consent form.

Exclusion Criteria:

1. Those who suffer from other breast diseases or breast pain caused by other reasons,such as mastitis, breast cancer, etc;

2. Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignanttumors, hematological diseases, and psychiatric disorders;

3. Patients who have been previously diagnosed with dysfunctional uterine bleeding,amenorrhea, polycystic ovary syndrome, menopausal syndrome, hyperprolactinemia,Cushing's syndrome, and other diseases and still require treatment by adjustinghormone levels; Individuals who have been diagnosed with diseases that requirelong-term use of painkillers, such as dysmenorrhea, and are expected to be unable tostop using painkillers during the trial period.

4. Abnormal liver function (ALT or AST or ALP or GGT>1.2 times the upper limit ofnormal values) or abnormal kidney function (serum Cr or BUN or Urea>1.2 times theupper limit of normal values) that the researcher considers clinically significantand is not suitable for participation in clinical trials;

5. Women who are in pregnancy, lactation, menopause, or have a pregnancy plan withinthe past 6 months;

6. Chinese and western medicines and other therapies (including external applicationmedicine, acupuncture and moxibustion, etc.) used to treat breast hyperplasia orrelieve breast pain within 1 month or 5 half lives (whichever is the shortest)before screening and during the induction period, or contraceptives and sex hormonedrugs have been used within half a year;

7. Individuals with severe menstrual cycle and/or menstrual irregularities (menstrualcycle>35 days or<21 days and/or menstrual period<3 days or>7 days);

8. Individuals with allergic constitution and known allergies to the components of theexperimental drug prescription;

9. Suspect or have a history of alcohol and drug abuse;

10. Select patients who have participated in clinical trials and used investigationaldrugs within the previous month;

11. Failure to follow the physical contraceptive measures recognized by researchers forcontraception;

12. According to the researchers' assessment, there may be other conditions orconditions that reduce the likelihood of inclusion or complicate the trial, such asfrequent changes in the work environment that can lead to loss to follow-up, andindividuals who cannot provide sufficient informed consent due to mental andbehavioral disorders.