A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis

Study Overview
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Brief Summary
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This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.

Detailed Description
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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.

Official Title
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A Single Arm Study of Traditional Chinese Medicine for Treatment of Plasma Cell Mastitis

Conditions
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Plasma Cell Mastitis

Intervention / Treatment
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* Drug: Traditional Chinese medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria for plasma cell mastitis. Women aged > 20 years and ≤ 60 years. Karnofsky Performance Status (KPS) Scale score ≥ 70. Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups. Exclusion Criteria: Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period. Patients with serious underlying diseases, such as diabetes, cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases. Allergic constitution, such as a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients of the drugs used in this trial. Recent use of antidepressants and other psychotropic drugs. Hormone and immunosuppressive therapy were used one month before enrollment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Chinese medicine group<br>Traditional Chinese medicine, twice daily | Drug: Traditional Chinese medicine<br>* Traditional Chinese medicine, oral administration, twice daily<br>* Other names: Traditional herbal medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate | the proportion of patients who completely respond to the treatment at any study time point | During treatment（1 month to 6 months） | 
| Clinical response rate | the proportion of patients who respond to the treatment at any study time point | During treatment（1 month to 6 months） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical rate | the proportion of patients who receive surgery at any study time point | During treatment（1 month to 6 months） | 
| Local recurrence rate | the proportion of patients who recur at any study time point | 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. | During treatment（1 month to 6 months） |