Female breast hyperplasia
Conditions
Interventions
Exposed group:Yanghe Jiening Plaster: For external use only. Warm to soften then apply to the affected area.
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Female aged 18-50 years; (2) Meeting Western diagnostic criteria for breast hyperplasia with a disease duration of at least 3 menstrual cycles (based on medical records); (3) Presence of a target mass upon breast palpation during screening with a mean NRS score >3 for self-reported breast pain/swelling within 7 days prior to menstruation; (4) Willing to participate in the study and having provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Severe hepatic or renal dysfunction; (2) Breast nodules classified as BI-RADS >3 with any single nodule =1.5 cm; (3) Patients undergoing exogenous estrogen therapy; (4) Women with irregular menstrual cycles menopausal women or patients with mastitis; (5) Patients scheduled for surgical excision of breast masses; (6) Patients with severe cardiac diseases (e.g. myocardial infarction unstable angina congestive heart failure classified as NYHA Class III-IV or severe arrhythmia) severe pulmonary diseases (e.g. acute exacerbation of chronic bronchitis asthma or COPD) or other severe conditions (e.g. cerebral infarction endocrine disorders psychiatric disorders or malignancies) that preclude study participation; (7) Pregnant or lactating women women of childbearing potential with a negative pregnancy test or those planning pregnancy during the study or within 6 months after the last dose; (8) Known allergy to any component of the investigational product or a history of hypersensitivity; (9) Participation in another clinical trial within 3 months prior to screening or current participation in any clinical trial; (10) Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean NRS score for breast pain 7 days before menstruation compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence Rate;Change in Breast Mass Hardness Score (by Palpation) from Baseline;Change in Breast Mass Hardness Score (by Elastography Ultrasound) from Baseline;Change in Size of Breast Nodules/Masses from Baseline; | — |
Countries
China
Contacts
Public ContactZhang Dongxiao
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed