Clinical study of
- Conditions
- acne mastitis
- Registration Number
- ITMCTR2200006068
- Lead Sponsor
- Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria for acne mastitis;
(2) Currently in the pus-forming stage;
(3) Premenopausal women aged 18 to 50 years (including 18 and 50 years old);
? No previous thyroid disease, normal thyroid function, normal heart, liver and kidney function;
? Voluntarily accept the clinical experiment and sign the informed consent.
The diagnostic criteria for acne mammary carbuncle refer to the Traditional Chinese Medicine Diagnosis and Efficacy Criteria promulgated by the State Administration of Traditional Chinese Medicine, including:
? There is lumpy pain next to the areola, the skin is reddish, and pus forms in about 7 to 10 days. After the ulceration, the pus has a foul smell, or it recurs after healing, and the pus is accompanied by headache and fever.
? The onset is more common on one side of the areola, which is often accompanied by a history of retraction of the nipple. A stinky scum-like substance may be secreted inside the sunken nipple. A few patients are accompanied by bloody or watery nipple discharge.
? If the disease develops repeatedly, scars may form, and a stiff lump appears at the areola, which sticks to the skin.
? After the ulceration, milk leakage is formed, and the mouth does not close for a long time. Use a ball-headed silver wire to probe into the sore hole and protrude from the nipple.
? Breast B-ultrasound MRI can be helpful for diagnosis, and core needle puncture histopathological examination can confirm the diagnosis.
(1) Combined with inflammatory breast cancer, acute mastitis, benign breast tumors and other breast diseases with indications for surgery;
(2) Patients with serious primary diseases, or serious diseases that affect their survival (such as tumor or AIDS), or mentally or legally disabled patients;
(3) Abnormal laboratory indicators:
? ALT, AST, and BUN exceed the upper limit of normal values by 20%;
? Abnormal ECG and other laboratory parameters with clinical significance;
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Breast shape;
- Secondary Outcome Measures
Name Time Method