This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis. This study will include 50 patients with plasma cell mastitis. After providing written informed consent, the participants will receive traditional herbal medicine twice daily. Efficacy will be assessed every 15 days. If the disease progresses, the participant will withdraw from the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Traditional Chinese medicine, oral administration, twice daily
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGClinical cure rate
the proportion of patients who completely respond to the treatment at any study time point
Time frame: During treatment(1 month to 6 months)
Clinical response rate
the proportion of patients who respond to the treatment at any study time point
Time frame: During treatment(1 month to 6 months)
Surgical rate
the proportion of patients who receive surgery at any study time point
Time frame: During treatment(1 month to 6 months)
Local recurrence rate
the proportion of patients who recur at any study time point
Time frame: Within 6 months after treatment
Adverse events (AE) and serious adverse events (SAE)
For adverse events (AE) and serious adverse events (SAE), refer to NCI-CTC AE 5.0 standard.
Time frame: During treatment(1 month to 6 months)
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