跳至主要内容
临床试验/ITMCTR2100004785
ITMCTR2100004785招募中1 期

The Efficacy of Xiaoyu Xiezhuo Decoction on Chronic Kidney Disease in Stage 3-4: a Multicenter Clinical Study

Zhejiang Hospital of Traditional 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
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 75(—)
性别
All

入选标准

  • 1. Patients who meet the Western medicine CKD 3-4 diagnostic criteria;
  • 2. Meet the standard of Qi deficiency and blood stasis syndrome in TCM;
  • 3. Those who are 18 to 75 years old, have no gender limit, and have not yet received dialysis treatment;
  • 4. After basic blood pressure reduction, blood pressure <= 140/90mmHg;
  • 5. The blood creatinine (Scr) change within 15% in the past 3 months, hemoglobin (Hb)> 100g/L, no serious acidosis occurred;
  • 6.24h urine protein quantification (24hUpr) <= 2.5g (at least two consecutive determinations, take the average);
  • 7. The primary disease is chronic glomerulonephritis, hypertension, diabetes, hepatitis B-related nephritis, etc., and the condition is stable;
  • 8. The patient agrees to the treatment of this study, joins the chronic disease management, and signs an informed consent form;
  • 9. No other drug test has been performed in the past 3 months or the effective drug wash-out period has passed.

排除标准

  • 1. Being treated with hormones, non-steroidal anti-inflammatory drugs or immunosuppressive agents;
  • 2. Severe arrhythmia, acute heart failure, myocardial infarction, acute stroke, unstable angina, NYHA classification IV (New York Heart Association Heart Function Classification Standard);
  • 3. Patients with acute infectious diseases, surgery and traumatic stress; patients with chronic infectious diseases such as chronic hepatitis B active and prolonged, decompensated liver cirrhosis, or active tuberculosis;
  • 4. Diseases that are accompanied by severe organ damage that affect the survival of patients, such as malignant tumors, HIV infection, etc.;
  • 5. Patients with severe primary diseases such as cardiovascular, blood system, nervous system, digestive system, respiratory system, etc., and those with obvious bleeding tendency;
  • 6. Complicated with hyperkalemia, heart failure and other life-threatening persons;
  • 7. GFR fluctuation range >= 30% within 3 months before enrollment;
  • 8. Severe allergies, allergic or intolerant to certain drugs known in the study;
  • 9. Patients during pregnancy or lactation;
  • 10. Those who have had a history of hemorrhage or blood transfusion in the past 3 months, and have signs of serious clinical infection or acidosis;
  • 11. Patients who have a history of mental illness or communication and cognitive dysfunction and other poor compliance who cannot cooperate;
  • 12. Non-yellow race.

研究者

发起方
Zhejiang Hospital of Traditional Chinese Medicine

相似试验