Breast hyperplasia
Conditions
Interventions
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) In line with the diagnosis of hyperplasia of mammary glands, the course of the disease is> 3 months; (2) 18-50 years old, female, with basic regular menstrual cycle (21-35 days) and menstrual period (3-7 days); (3) Breast color Doppler ultrasound BI-RADS is graded 2-3; (4) The average score of VAS within the pain-involved days during the lead-in period is >= 4 points and there is still a target mass on palpation; (5) Pain days >= 3 days (in the first month of treatment) Accumulated pain days within); (6) Subjects with informed consent, voluntarily taking the test and signing informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with breast inflammation, breast tumors, and other breast diseases with surgical indications; (2) Patients with severe primary heart, brain, liver, kidney, blood and other diseases combined with severe diseases that affect their survival; (3) Cr> upper limit of normal value; ALT, AST, BUN> 20% upper limit of normal value; (4) Those with local breast skin damage; (5) Pregnant or breast-feeding women, those with pregnancy plans in the past six months; (6) People with allergic physique, or skin allergic to external preparations such as rubber paste, or known to Those who are allergic to the ingredients of the medicine; (7) Alcohol and/or psychoactive substances, drug abusers and dependents; (8) Those who are participating in other clinical trials; (9) Those who are used to treat breast hyperplasia within 1 month before this treatment Chinese and Western medicines (including topical medicine, acupuncture, etc.) and have not used hormone drugs within six months; (10) According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as working environment Frequent changes and other situations that are likely to cause loss to follow-up, and those who cannot give full informed consent due to mental and behavioral disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain grading index assessment;Pain intensity assessment on the most painful day;Duration of pain;Visual analog scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast target mass range and maximum diameter;Breast color ultrasound examination target mass;TCM Syndrome Points; | — |
Countries
China
Contacts
Public ContactGao Qingqian
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed