A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Paronychia progress rate
研究概览
简要总结
This is a randomized control trial evaluating the efficacy of zanthoxylum nitidum tincture on preventing progression of paronychia caused by afatinib from grade 1 to grade 2/3. Enrolled participates will randomly receive original treatment or original treatment plus zanthoxylum nitidum tincture immersion of the sick nail(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed non-small cell lung cancer；
- •Undergoing treatment with afatinib；
- •With grade 1 paronychia；
- •Age between 18 to 80 years old；
- •Estimated life expectancy of more than months；
- •With the written informed consent.
排除标准
- •Paronychia before afatinib treatment;
- •Grade 2 or severer paronychia;
- •Stop using afatinib or with reduced dose of afatinib;
- •Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.
- •Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.
研究组 & 干预措施
Combination group
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, plus local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day, till paronychia relief or progression.
干预措施: zanthoxylum nitidum tincture (Drug)
Combination group
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, plus local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day, till paronychia relief or progression.
干预措施: tetracycline ointment (Drug)
Control group
Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day, till paronychia relief or progression.
干预措施: tetracycline ointment (Drug)
结局指标
主要结局
Paronychia progress rate
时间窗: Through study completion, an average of 10 days.
Incidence of grade 2 or more paronychia during paronychia treatment period will be reported. This period will be from randomization till paronychia relief or progression. Frequency of evaluation for paronychia will be everyday.
次要结局
- Time to paronychia progress(Through study completion, an average of 10 days.)
- Time to paronychia relief(Through study completion, an average of 10 days.)
研究者
Haibo Zhang
Professor
Guangzhou University of Traditional Chinese Medicine