Clinical trial NCT05530226: A Single Arm Study of Traditional Chinese Medicine for Plasma Cell Mastitis
Official title: A Single Arm Study of Traditional Chinese Medicine for Treatment of Plasma Cell Mastitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Plasma Cell Mastitis
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single arm study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical cure rate
timeFrame: During treatment（1 month to 6 months）
measure: Clinical response rate
timeFrame: During treatment（1 month to 6 months）
Secondary outcomes:
measure: Surgical rate
timeFrame: During treatment（1 month to 6 months）
measure: Local recurrence rate
timeFrame: Within 6 months after treatment
measure: Adverse events (AE) and serious adverse events (SAE)
timeFrame: During treatment（1 month to 6 months）
Other outcomes:
measure: Expression of immune cells
timeFrame: During treatment（1 month to 6 months）
measure: Expression of cytokines (IL, INF-r, TNF-a)
timeFrame: During treatment（1 month to 6 months）
measure: C-reactive protein
timeFrame: During treatment（1 month to 6 months）
measure: Clinical symptom scores
timeFrame: During treatment（1 month to 6 months）
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Caigang Liu
role: PRINCIPAL_INVESTIGATOR
References: