Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary Glands

Exclusion Criteria12

• Those who suffer from other breast diseases or breast pain caused by other reasons, such as mastitis, breast cancer, etc;
• Patients with severe cardiovascular, cerebrovascular, liver, kidney, malignant tumors, hematological diseases, and psychiatric disorders;
• 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 adjusting hormone levels; Individuals who have been diagnosed with diseases that require long-term use of painkillers, such as dysmenorrhea, and are expected to be unable to stop using painkillers during the trial period.
• Abnormal liver function (ALT or AST or ALP or GGT>1.2 times the upper limit of normal values) or abnormal kidney function (serum Cr or BUN or Urea>1.2 times the upper limit of normal values) that the researcher considers clinically significant and is not suitable for participation in clinical trials;
• Women who are in pregnancy, lactation, menopause, or have a pregnancy plan within the past 6 months;
• Chinese and western medicines and other therapies (including external application medicine, acupuncture and moxibustion, etc.) used to treat breast hyperplasia or relieve breast pain within 1 month or 5 half lives (whichever is the shortest) before screening and during the induction period, or contraceptives and sex hormone drugs have been used within half a year;
• Individuals with severe menstrual cycle and/or menstrual irregularities (menstrual cycle>35 days or<21 days and/or menstrual period<3 days or>7 days);
• Individuals with allergic constitution and known allergies to the components of the experimental drug prescription;
• Suspect or have a history of alcohol and drug abuse;
• Select patients who have participated in clinical trials and used investigational drugs within the previous month;
• Failure to follow the physical contraceptive measures recognized by researchers for contraception;
• According to the researchers' assessment, there may be other conditions or conditions that reduce the likelihood of inclusion or complicate the trial, such as frequent changes in the work environment that can lead to loss to follow-up, and individuals who cannot provide sufficient informed consent due to mental and behavioral disorders.