Plasma Cell Mastitis
Conditions
Brief summary
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
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.
Interventions
DRUGTraditional Chinese medicine
Traditional Chinese medicine, oral administration, twice daily
Sponsors
Shengjing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single arm study
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Meet the diagnostic criteria for plasma cell mastitis. 2. Women aged \> 20 years and ≤ 60 years. 3. Karnofsky Performance Status (KPS) Scale score ≥ 70. 4. Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.
Exclusion criteria
1. 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. 2. Patients with serious underlying diseases, such as diabetes, cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases. 3. 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. 4. Recent use of antidepressants and other psychotropic drugs. 5. Hormone and immunosuppressive therapy were used one month before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cure rate | During treatment（1 month to 6 months） | the proportion of patients who completely respond to the treatment at any study time point |
| Clinical response rate | During treatment（1 month to 6 months） | the proportion of patients who respond to the treatment at any study time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical rate | During treatment（1 month to 6 months） | the proportion of patients who receive surgery at any study time point |
| Local recurrence rate | Within 6 months after treatment | the proportion of patients who recur at any study time point |
| Adverse events (AE) and serious adverse events (SAE) | During treatment（1 month to 6 months） | For adverse events (AE) and serious adverse events (SAE), refer to NCI-CTC AE 5.0 standard. |
Other
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | During treatment（1 month to 6 months） | Expression of c-reactive protein |
| Expression of cytokines (IL, INF-r, TNF-a) | During treatment（1 month to 6 months） | Expression of cytokines (IL, INF-r, TNF-a) |
| Clinical symptom scores | During treatment（1 month to 6 months） | Clinical symptom scores were measured using traditional Chinese medicine clinical symptom assessment with reference to The Disease Diagnosis Curative Effect of Traditional Chinese Medicine Standard. The clinical symptom scales include mass size, swelling, discharge, retraction, abscess, fistula. The higher the score, the worse the symptom. Clinical symptom scores of patients before and after treatment were observed and compared. |
| Expression of immune cells | During treatment（1 month to 6 months） | Expression of immune cells (T cell, B cell, NK cell) |
Countries
China
Contacts
Primary ContactNan Niu, MD
Backup ContactCaigang Liu, MD
Outcome results
None listed