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Study on the Immuno-Microbial Characteristics of Granulomatous Mastitis

Study on the Immuno-Microbial Characteristics of Granulomatous Mastitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500102313
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-03-25
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatous Mastitis

Interventions

Disease Group:None
Control Group:None

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Disease Group (Case Group): (1) Non-lactating, non-pregnant females; (2) Aged 25–40 years; (3) Meeting the diagnostic criteria of Liver Channel Stagnation-Heat Syndrome () or Phlegm-Heat Stasis Syndrome () for granulomatous mastitis according to Traditional Chinese Medicine (TCM) Guidelines; (4) Pathologically confirmed granulomatous mastitis; (5) No ulceration or skin breakdown in the affected breast; (6) Informed consent obtained, with voluntary participation and signed informed consent form. 2. Control Group: (1) Non-lactating, non-pregnant females; (2) Aged 25–40 years; (3) In good general health, without diagnosed systemic diseases, and not undergoing medical treatment; (4) Pathologically confirmed breast fibroadenoma, breast cyst, or hyperplasia; (5) Informed consent obtained, with voluntary participation and signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have received treatment with glucocorticoids, antibiotics, and immunosuppressants in the past month; 2. Suffering from duodenal ulcer, gastric ulcer, gastric bleeding or other gastrointestinal diseases; 3. Patients with serious primary diseases such as liver, heart, kidney, lung, hematopoietic system, and mental illness; 4. Suffering from immune diseases such as rheumatoid arthritis, systemic lupus erythematosus, and autoimmune skin diseases; 5. History of other confirmed infections within three months.

Design outcomes

Primary

MeasureTime frame
Blood routine ;CRP;Erythrocyte sedimentation rate;Immune globulin;Lymphocyte subpopulation;

Secondary

MeasureTime frame
Temperature;Heart rate;Breath rate;Blood pressure;Serum biochemical indicators;Blood fat;Sex hormone;Cytokines;

Countries

China

Contacts

Public ContactHongfeng Chen

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

chhfluk@126.com+86 189 1776 3058

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026