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

Phase 2

Recruiting

• Conditions: Plasma Cell Mastitis
• Interventions: Drug: Traditional Chinese medicine

• Registration Number: NCT05530226
• Lead Sponsor: Shengjing Hospital

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.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-03
• Study First Submitted QC: 2022-09-03
• Last Update Submitted: 2022-09-03
• Study First Posted: 2022-09-07
• Last Update Posted: 2022-09-07
• Primary Completion: 2022-10-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Traditional Chinese medicine group	Traditional Chinese medicine	Traditional Chinese medicine, twice daily

Primary Outcome Measures

Name	Time	Method
Clinical response rate	During treatment（1 month to 6 months）	the proportion of patients who respond to the treatment at any study time point
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

Secondary Outcome Measures

Name	Time	Method
Local recurrence rate	Within 6 months after treatment	the proportion of patients who recur at any study time point
Surgical rate	During treatment（1 month to 6 months）	the proportion of patients who receive surgery 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.

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China