Clinical Study on Serology and Pathology of Granulomatous Mastitis of Different TCM Syndrome Types
- Conditions
- granulomatous mastitis
- Registration Number
- ITMCTR2200006848
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion criteria of GM patients
(1) Female patients who meet the diagnostic criteria of traditional Chinese and western medicine and syndromes of GM and are diagnosed as GM by pathological biopsy.
(2) Women older than 18 years.
(3) No other basic diseases.
(4) Volunteer to participate in clinical research and sign the informed consent form.
Inclusion criteria for healthy volunteers
(1) Women aged>18 years, matched with the age of patients with granulomatous mastitis.
(2) No other basic diseases.
(3) Volunteer to participate in clinical research and sign the informed consent form.
GM patient exclusion criteria
(1) Patients with breast fibroma, breast cancer, breast hyperplasia and other breast tumors or breast diseases.
(2) Patients with serious primary diseases, serious diseases that affect the survival of patients, or mentally and legally recognized disabled patients.
(3) The patients in the clinical recovery period and the patients in the other three stages have intersected.
Exclusion criteria for healthy volunteers
(1) Health volunteers participating in other medical research.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Polynuclear giant cells, neutrophils, lymphocytes, plasma cells, microabscesses, granulomas;White blood cell count,Percentage of neutrophils,CRP,ESR,IL-8,IL-10,IL-22,IL-23,IL-33,PRL;TNF-a\CD68\CD163\CCL-5\IgG4 \TLR2\TLR4;Mycobacterium tuberculosis;
- Secondary Outcome Measures
Name Time Method Bacterial culture of secretions;Breast ultrasound;Breast pain;