granulomatous lobular mastitis
Conditions
Interventions
Experimental group:Trametes robiniophila Murr Granules + Traditional Chinese medicine fixed prescription treatment/follow-up
Control group:Traditional Chinese medicine fixed prescription treatment/follow-up
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Non-lactating patients with mastitis abscess formation 1) Women aged 18-70; 2) Refer to the clinical diagnostic reference standards of the Expert Consensus on the Diagnosis and Treatment of granulomatous lobular mastitis of Traditional Chinese Medicine (2021 edition); 3) < 90 days after onset; 4) Liver function, renal function and coagulation function are normal; 5) Agree not to participate in other intervention studies before completing the study.
Exclusion criteria
Exclusion criteria: 1) The doctor thinks that participating in the trial is not in the best interests of patients, or there are any circumstances that make the study unsafe; 2) Patients with serious diseases of heart, liver, kidney and endocrine system;Patients with active stage of malignant tumor; Patients with other autoimmune diseases; Patients with mental illness; 3)Nursing or pregnant patients; 4) Those who have allergic history to this medicine or its components after taking it; 5) receiving antidepressant or other psychotropic drugs within 30 days before screening and evaluation; 6) Those who received anti-tuberculosis therapy, antidepressants, or other psychotropic drugs in the 30 days prior to the screening evaluation, any treatment that may affect this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate;Recurrence rate during follow-up period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement time;The maximum diameter change of the lesion under ultrasound;Clinical status;Surgical intervention rate;Skin rupture area;Skin redness and swelling area;Duration of systemic symptoms;CD4+/CD8+, cytokines, C-reactive protein, IgA, IgG, rheumatoid factor; | — |
Countries
China
Contacts
Public ContactXieXiaohong
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed