Non-Puerperal Mastitis
Conditions
Interventions
Treatment Group:Catechu water decoction irrigation
Control Group:normal saline flush
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Female, age = 18 years; 2) Meets diagnostic criteria for non-lactational mastitis (granulomatous mastitis or plasmacytic mastitis); 3) Is in the fistula stage (defined as: after drainage of an abscess via incision, aspiration, or spontaneous rupture, the fistula persists for more than 2 weeks and is confirmed by clinical examination or breast ultrasound to be unhealed with evidence of sinus tract, pus cavity, or hypoechoic area);
Exclusion criteria
Exclusion criteria: 1) Pathological examination confirms the presence of Mycobacterium tuberculosis or malignant tumor cells in the tissue; 2) Pregnant or breastfeeding women; 3) Individuals participating in other interventional clinical trials, or those who, during the intervention period specified in this study, self-administer other local or systemic treatments for breast fistulas (e.g., systemic use of antibiotics, corticosteroids, or other traditional Chinese medicine external therapies); 4) Patients with severe abnormalities in heart, liver, or kidney function, or uncontrolled hypertension (e.g., systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg after drug treatment) or diabetes (e.g., fasting blood glucose =11.1 mmol/L or glycated hemoglobin =9%); 5) Individuals with mental illness or cognitive impairments who are unable to cooperate with the intervention and assessment; 6) Known allergy to catechu or any excipients in the formulation; 7) Investigators believe there are any circumstances that may affect the implementation of the trial protocol or assessment, or consider the patient unsuitable for participation in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Clinical Response (CCR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Sinus Tract Closure;Ultrasonographic Sinus Tract Cross-Sectional Area (cm²);Size of Inflammatory Mass Associated with Sinus Tract;Pain Score During Irrigation (assessed by Visual Analog Scale, VAS);Imaging Response Rate at 3 Months Post-Closure;Recurrence Rate;Non-Puerperal Mastitis Ulcerative Stage Score (NPM-US Score); | — |
Countries
China
Contacts
Public ContactXiufei Gao
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed