ITMCTR2000003531招募中1 期
A Multi-Center, Randomized, Open-Label, Positive Parallel Controlled Clinical Study on the Efficacy and Safety of Pi-Yan-Ning Decotion in the Treatment of Grade II Acneiform Rash Induced by Anti-tumor Targeted Drugs
The First Affiliated Hospital of Zhejiang Chinese Medical University0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •1. Male or female patients aged >18 years;
- •2. Patients receiving anti-tumor targeted drugs;
- •3. Grade III rash according to NCI-CTC 5.0 standard;
- •4. KPS > 60, life expectancy >=3 months;
- •5. The functional level of major organs met the following criteria: 1) ANC (> 1.5 *10^9/L), PLT (> 75 *10^9/L), Hb (> 80 g/L); 2) TBIL < 1.5 ULN, ALT, AST < 2.5 ULN, with liver metastasis < 5 ULN, BUN and Cr < 1 ULN or endogenous creatinine clearance (>50 ml/min) (Cockcroft-Gault formula);
- •6. Signed informed consent.
排除标准
- •1. Life expectancy < 3 months
- •2. Skin lesions or skin diseases considered to affect the study, or history of allergic contact with other drugs;
- •3. Received hormones or antibiotics or any other drugs that may affect the skin rash within 1 week before the start of our research, including Chinese patent medicine and herbal medicine;
- •4. Serious or uncontrollable systemic diseases (such as unstable respiration, circulation, digestion, urinary and blood system diseases, ect);
- •5. Any unstable systemic diseases (including active infection, grade III hypertension, unstable angina pectoris, congestive heart failure, or metabolic diseases, etc.);
- •6. Previous history of neurological or mental disorders, including epilepsy and dementia;
- •7. Pregnancy or lactation;
- •8. The subject was considered not be able to complete the study or comply with the requirements of this study (due to management or other reasons).
研究者
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