Breast pain Signs and Symptoms
Conditions
Interventions
Participants will be randomly allocated into two groups. The method of randomisation: central randomisation run by the leading clinical site (3rd Affiliated Hospital of Beijing University of Chinese M
Sponsors
Yunnan Yousheng Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. 18 - 55 years old, female, pre- or peri-menopause 2. Meeting the diagnostic criteria of breast pain; including women with breast nodules, the longest diameter of B-ultrasonic solid nodules =2cm or the longest diameter of B-ultrasonic cystic nodules =2 cm 3. The number of days of breast pain for each menstrual cycle is equal or longer than 3 days and visual analog scale (VAS) = 4 points; if treated before, the pain symptom could not relieve for three consecutive menstrual cycles or more 4. Women diagnosed as hysteromyoma according to the diagnostic criteria of hysteromyoma will be included 5. The menstrual cycle and the menstrual period are basically regular, and the menstrual cycle is about 28 ± 7 days
Exclusion criteria
Exclusion criteria: 1. Women who are preparing for pregnancy or who are pregnant or lactating 2. Patients with allergic constitution, or allergic to the test drug or its components 3. Breast image report and data system (BI-RADS) classification > level 3 4. Patients with breast malignant tumors, inflammatory diseases and other endocrine diseases (such as pituitary tumors) 5. Taking contraceptives during the trial and using hormonal drugs within the first three months of screening 6. Those who have taken Chinese or Western medicines to treat this disease within 1 month before screening or those who participated in other clinical drug trials 7. Patients with severe primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or patients with mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The degree of breast pain measured using short-form of McGill questionnaire (SF-MPQ) at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up) 2. The duration of pain: the number of days of breast pain during each menstrual cycle measured at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breast nodule size: the size of the nodule is determined by both palpation and B-ultrasound at baseline, 12 weeks ± 3 days (end of treatment) 2. Hysteromyoma size (if complicated): abdominal uterus colour ultrasound is used for examination and measurement at baseline, 12 weeks ± 3 days (end of treatment) 3. Menstrual conditions: including menstrual bleeding volume, menstrual cycle, dysmenorrhea, etc, measured at baseline, 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up) 4. Safety outcome indicators: 4.1. General physical examination items measured at baseline, 12 weeks ± 3 days (end of treatment) 4.2. Blood, urine, stool routine samples at baseline, 12 weeks ± 3 days (end of treatment) 4.3. Electrocardiogram, liver and kidney function measured using blood biochemical tests at baseline, 12 weeks ± 3 days (end of treatment) 4.4. Other symptoms and signs other than pain measured using patient diary at 4 weeks ± 3 days (duration of treatment), 8 weeks ± 3 days (duration of treatment), 12 weeks ± 3 days (end of treatment), 24 weeks ± 3 days (end of follow-up) | — |
Countries
China
Contacts
Public ContactXiao-hua Pei
Outcome results
None listed