Clinical Trial of Ruxian Zengsheng No. 1 Decoction
Clinical Trial of Ruxian Zengsheng No. 1 Decoction
A prospective, open, randomized, controlled phase II clinical study is planned to clarify the
 efficacy and related adverse reactions of Mammary Glandular Hyperplasia No. 1 Decoction in
 the treatment of liver-qi stagnation type breast hyperplasia, relieve the pain of patients
 with breast hyperplasia, and improve the quality of life of patients.
1. This study is a prospective, open, randomized, controlled Phase II clinical study.
 Strictly follow the design requirements of the clinical research, randomly enroll
 patients, control each link of the study with high quality, and obtain objective
 research results to improve the evidence-based medicine evidence of the breast
 hyperplasia treatment of liver-stagnation and qi stagnation type breast hyperplasia with
 Rugongshengsheng No.1 prescription;

 2. Recruiting 137 patients with liver-stagnation and qi stagnation type breast hyperplasia
 through the Breast Center Clinic of the Affiliated Hospital of Qinghai University (see
 the inclusion criteria for details) (see the research plan for the specific calculation
 method), and randomly divided into 91 cases according to the 2:1 random number method
 Group, 46 cases of control group. The research group was treated with No.1
 Rugdenzengsheng prescription for a total of 1 course of treatment, each course of 14
 days, avoiding the menstrual period. The control group was given observation treatment
 and follow-up in outpatient clinic. All patients will be followed up by telephone or
 outpatient by a dedicated person, and the results of the follow-up will be recorded
 objectively;

 3. Specific treatment plan: The study group was treated with Mammary gland Hyperplasia No.
 1 orally, a total of 1 course of treatment, each course of 14 days, avoiding the
 menstrual period. The specific composition of Mammary Gland Hyperplasia No. 1 Recipe:
 Angelica 10g, Radix Paeoniae Alba 10g, Atractylodes Macrocephala 10g, Ginger 3g,
 Peppermint 6g, Vinegar Green Peel 6g, Lychee Seed 12g, Tangerine Seed 10g, Corydalis
 10g, Fritillaria 6g, Trichosanthis 10g, Kombu 20g , Mustard seeds 10g, Moutan bark 6g,
 Poria 10g, Beibuihu 6g. Method of administration: 14 doses in total, taken twice a day.
 The medicine is formulated in the herbal medicine room of the Affiliated Hospital of
 Qinghai University, with strict quality control;

 4. All patients will be followed up by telephone or on-site within one week after
 treatment. The evaluation criteria are detailed in the attached table. The curative
 effect evaluation standard of hyperplasia of mammary glands is mainly through the
 scoring method. The analgesic curative effect standard (NRS score on the most painful
 day): clinical recovery: the pain disappears completely; marked effect: the pain is
 significantly reduced, only occasional pain or only slight tenderness; effective : Pain
 is reduced or tenderness is reduced; Ineffective: Pain remains unchanged or worsened. In
 addition, collect clinical pathological data of patients, such as age, gender,
 reproductive history, menstrual history, family history, breastfeeding history, etc.;

 5. Secondary efficacy indicators: safety evaluation, safety endpoints include the incidence
 of adverse events and adverse reactions, liver function, renal function and urine
 routine laboratory examinations before and after treatment;

 6. Apply for ethical review by the ethics committee of the Affiliated Hospital of Qinghai
 University, and conduct research in strict accordance with the ethical requirements of
 the ethics committee of the Affiliated Hospital of Qinghai University.
Inclusion Criteria:

 1. Healthy women over 18 years of age;

 2. Patients who meet the diagnostic criteria for breast color Doppler ultrasound
 diagnosis of breast hyperplasia and the course of disease exceeds 3 months;

 3. Meet the syndrome differentiation criteria for liver-stagnation and qi stagnation
 (main symptoms are ① breast distension Pain and pain; ② breast pain and/or lumps are
 related to menstruation and mood changes; ③ irritability and irritability; ④ flank
 fullness. Secondary symptoms: ① the lumps are single, soft and tender; ② Young women;
 ③Irregular menstruation or dysmenorrhea; ④Pale red tongue, thin white or thin yellow
 coating, stringy pulse. With 3 main symptoms or 2 main symptoms + 2 secondary
 symptoms);

 4. breast color ultrasound, breast molybdenum Target, or breast MRI showed BI-RADS 2-3;

 5. NRS (0-10 pain rating) score ≥ 4 points on the most painful day before treatment,
 according to the score, the pain is divided into mild 3 points, moderate Grade 4-6
 points, severe 7-10 points;

 6. Voluntarily participate in the clinical study and sign the informed consent form after
 the informed consent (patients voluntarily accept the study and sign the informed
 consent).

 Exclusion Criteria:

 1. Patients with other breast diseases or other causes of breast pain (such as mastitis,
 breast cancer, etc.);

 2. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney,
 malignant tumors, blood system diseases, and Patients with mental illness;

 3. Patients who have been confirmed to have dysfunctional uterine bleeding, amenorrhea,
 polycystic ovary syndrome, menopausal syndrome and hyperprolactinemia before
 treatment, still need to regulate hormone levels for treatment;

 4. Patients diagnosed with hypercortisolism before treatment still need bromocriptine
 treatment;

 5. Menstrual period is more than 7 days, menopause and severe irregular menstrual cycle;

 6. ALT, AST, ALP, TBIL , GGT is higher than the upper limit of normal; or abnormal blood,
 urine, electrocardiogram and other examination items;

 7. pregnant or breastfeeding women, or patients with pregnancy plans in the next six
 months;

 8. 1 before treatment Use Chinese or Western medicine to treat breast hyperplasia
 (including painkillers, topical drugs, acupuncture, etc.) within the month and during
 the treatment period, and use hormonal drugs (except for long-term use), and oral
 contraceptives within six months;

 9. People who are known to be allergic to the ingredients of the test drug prescription;

 10. Past alcohol or drug abuse history;

 11. Patients who participated in other clinical studies within 3 months before enrollment;

 12. According to the judgment of the researchers, there are other diseases Or
 circumstances will reduce the possibility of enrollment or complicate enrollment. For
 example, frequent changes in the work environment may cause loss to follow-up, and
 patients with mental and behavioral disorders, or the inability to sign informed
 consent.