A Single Arm Study of Traditional Chinese Medicine for Treatment of Plasma Cell Mastitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
This is a single-center, single-arm, open-label trial evaluating the efficacy and safety of traditional Chinese medicine for plasma cell mastitis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for plasma cell mastitis.
- •Women aged > 20 years and ≤ 60 years.
- •Karnofsky Performance Status (KPS) Scale score ≥
- •Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.
排除标准
- •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.
研究组 & 干预措施
Traditional Chinese medicine group
Traditional Chinese medicine, twice daily
干预措施: Traditional Chinese medicine (Drug)
结局指标
主要结局
Clinical response rate
时间窗: During treatment（1 month to 6 months）
the proportion of patients who respond to the treatment at any study time point
Clinical cure rate
时间窗: During treatment（1 month to 6 months）
the proportion of patients who completely respond to the treatment at any study time point
次要结局
- Local recurrence rate(Within 6 months after treatment)
- Surgical rate(During treatment（1 month to 6 months）)
- Adverse events (AE) and serious adverse events (SAE)(During treatment（1 month to 6 months）)