hyperplasia of mammary glands
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Meet the diagnostic criteria of mammary hyperplasia; 2)VAS score > 3 for most painful breast pain in 7 days before menstruation in previous menstrual cycle;3)Women aged between 18 and 55 with regular menstrual cycle ( 28±7 days), and menstrual period (3-7 days);4)have not used Chinese / Western medicine or acupuncture treatment for breast hyperplasia in the past 3 months; 5)signed informed consent and are willing to cooperate with the treatment. Note: patients who meet the above 5 criteria were eligible.
Exclusion criteria
Exclusion criteria: 1)Pre-menstrual VAS score diary card records were less than 7 days during the screening period;2)Patients with breast cancer or prebreast lesions confirmed by mammography or B-ultrasound or breast hyperplasia accompanied by breast neoplasms, mastitis and other breast diseases with indications for surgery;3)Complicated with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases, or digestive ulcer disease, or serious diseases affecting their survival (such as tumor or AIDS), or mental patients;4)pregnancy, lactation, menopause, or have a pregnancy plan in 6 months;5)patients who have taken sex hormone drugs or contraceptives in the last 3 months;6)those who are participating in or have recently participated in other clinical trials in the last 3 months. Note: All patients who met any of the above exclusion criteria were excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score of breast pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum sex hormone levels;Assessment of emotional state (SAS and SDS Self-rating Scales);Number of days with significant breast pain;Quality of Life Scale (SF-12 Scale);Breast mass size changes; | — |
Countries
China