granulomatous mastitis
Conditions
Interventions
test group:Chaihu Qinggan Tang
control group:methylprednisolone (Methylprednisolone)
Disease group:None
control group:None
Disease groups (validation queues):None
control group (validation queues):None
Sponsors
The First Affiliated Hospital of Hunan University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Part 1 Inclusion Criteria 1. Inclusion Criteria for the GM Group (1) Patients with breast pain, redness, swelling, or ulceration, and large hypoechoic areas on breast ultrasound suggestive of mastitis; (2) Patients diagnosed with granulomatous mastitis (GM) through surgical/puncture biopsy pathology; (3) Female patients aged 18–60 years (inclusive); (4) Patients without severe organic diseases; (5) Patients who provide informed consent and voluntarily sign the informed consent form. 2. Inclusion Criteria for the Control Group (1) Patients with benign breast diseases (BI-RADS 3 hypoechoic nodules on ultrasound) requiring surgical treatment; (2) Final pathological diagnosis confirming breast fibroadenoma; (3) Female patients aged 18–60 years (inclusive); (4) Patients without severe organic diseases; (5) Patients who provide informed consent and voluntarily sign the informed consent form. Part 2 Inclusion Criteria (1) . Pathological diagnosis of granulomatous mastitis confirmed by biopsy; (2) . Patients classified as having "Liver Channel Heat Accumulation Syndrome" according to Traditional Chinese Medicine (TCM) syndrome differentiation; (3) . Female patients aged 18–60 years (inclusive); (4) . Patients without severe organic diseases; (5) . Patients who provide informed consent and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Part 1 Exclusion Criteria 1. Pregnant or lactating patients; 2. Patients with a final surgical pathology confirming breast cancer; 3. Patients with other inflammatory diseases, endocrine disorders, or autoimmune diseases; 4. Patients deemed ineligible for participation by the investigator. Part 2 Exclusion Criteria 1. Patients who have received hormone therapy, immunosuppressants, triple anti-tuberculosis therapy, surgery, or other treatments, or those with other breast diseases or taking medications that may affect the study results; 2. Patients with malignant breast tumors, inflammatory diseases, endocrine disorders, or autoimmune diseases; 3. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders; 4.Pregnant or lactating women; 5. Patients who have participated in other clinical drug trials within the past month; 6. Patients with allergic constitutions or known allergies to the study drugs or their components; 7. Patients deemed ineligible for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chinese Medicine Symptom Score;Biomarkers ((currently unknown, pending combined multi-omics analysis)); | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast Lump Diameter;color ultrasound of the breast;VAS pain score;Blood count ;C-reactive protein; | — |
Countries
China
Contacts
Public ContactLifang Liu
The First Affiliated Hospital of Hunan University of Chinese Medicine
Outcome results
None listed