跳至主要内容
临床试验/ITMCTR2100004373
ITMCTR2100004373尚未招募1 期

Qingkepingchuan granules for acute exacerbation of COPD patients with syndrome of phlegm heat obstructing lung: a randomized, double-blind, placebo-controlled trial

Guangdong Provincial Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
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
40 至 85(—)
性别
All

入选标准

  • 1. Patients aged 40 to 85 years;
  • 2. Patients who meet the diagnostic criteria of COPD comprehensive evaluation group B, C and D, and they are in the acute exacerbation stage;
  • 3. Patients who are diagnosed with moderate to severe AECOPD;
  • 4. Patients who meet the Chinese medicine syndrome classification of phlegm heat obstructing lung;
  • 5. Patients who sign the written informed consent form.

排除标准

  • 1. Other respiratory diseases: bronchial asthma, bronchiectasis, bullae, pleural effusion, active tuberculosis and other lung diseases;
  • 2. Severe or uncontrollable diseases: hematological diseases; liver dysfunction (ALT or AST >=3 ULN, total bilirubin>=1.5 ULN), renal dysfunction (serum creatinine >177 umol/L or 2mg/dl), congestive heart failure (III-IV); immune deficiency, tumor, organ or bone marrow transplantation, HIV or immunosuppressive therapy in recent 3 months;
  • 3. Patients with diabetes or impaired glucose tolerance;
  • 4. Systemic glucocorticoids were needed in recent 3 months;
  • 5. Patients with confirmed history of alcohol, drug abuse or mental illness;
  • 6. Patients with dysphagia or gastrointestinal disease affecting drug absorption (reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, after subtotal gastrectomy);
  • 7. Patients who have known hypersensitivity to the study medication or some of its ingredients;
  • 8. Patients have been exposed to the study drug within one month before enrollment;
  • 9. Patients who are pregnant or lactating.

研究者

发起方
Guangdong Provincial Hospital of Chinese Medicine

相似试验