ITMCTR2200006505尚未招募1 期
A prospective, randomized and controlled clinical study on the treatment of diabetes nephropathy with chronic kidney disease (stage 3-4) by Chen's Tangshen recipe
onghua Hospital Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
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
- 18 至 80（—）
- 性别
- All
入选标准
- •(1) DKD patients with clinical diagnosis of CKD stage 3~4
- •(2) Aged 18 to 80 years old;
- •(3)Patients with type 2 diabetes who have been taking antidiabetic drugs or insulin treatment for half a year or more, with HbA1c=8%;
- •(4) Patients with 24-hour urine protein quantification=0.3g
- •(5)The patients were informed and signed the informed consent.
排除标准
- •1. Patients with type 1 diabetes;
- •2. Abnormal liver function test results (AST or ALT or alkaline phosphatase > 3 times ULN), or other known patients with acute and chronic active hepatitis and cirrhosis;
- •3. Previous history of EGFR decline > 30% within 2-3 months after using ACEI / ARB drugs;
- •4. Those who use hormone or immunosuppressant due to kidney disease or kidney transplantation;
- •5. Other chronic kidney diseases (such as chronic glomerulonephritis, chronic pyelonephritis, ischemic kidney disease, etc.) during screening;
- •6. Patients with blood pressure lower than 110 / 60mmHg (without antihypertensive drugs) before screening;
- •7. Those whose blood pressure was continuously higher than 180 / 100mmHg two weeks before screening;
- •8. Those with blood potassium level > 5.5 mmol / L during screening;
- •9. Patients with severe acute diabetes complications (ketoacidosis, lactic acidosis, hypertonic nonketotic diabetes coma, hypoglycemic coma) within 6 months before screening;
- •10. Patients with acute coronary syndrome, heart failure (NYHA score III-IV), or surgical treatment for heart related diseases, stroke or poor prognosis of stroke within the first 3 months of screening;
- •11. Those who have a history of mental illness or language disorder before screening and are unable to cooperate or unwilling to cooperate;
- •12. History of autoimmune diseases (such as systemic lupus erythematosus) before screening;
- •13. Those with a history of malignant tumor disease within the previous two years were screened
- •14. HIV patients;
- •15. Those who are allergic to the test drug;
- •16. Those who are participating in clinical trials of other drugs or who have participated in other drug trials within 3 months before screening (refer to those who are enrolled in the group and receive treatment of test drugs);
- •17. Female patients with pregnancy plan, pregnancy or lactation within half a year;
- •18. Other conditions that the investigator judges are not suitable for this test.
研究者
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