A randomized controlled clinical trial study protocol of Liuwei Dihuang Pills in the adjuvant treatment of diabetic kidney disease

Hospital of Chengdu University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Patients were diagnosed Diabetic Kidney Disease meeting the criteria of the 2014 Consensus of Experts on Prevention and Treatment of DKD of Chinese Diabetes Society;
•2. Patients aged between 25 and 75 years old;
•3. eGFR>=30mL/min/1.73m2 without dialytic treatments;
•4. For patients with hypertension, blood pressure<=140/90 mmHg; for the elderly, systolic blood pressure (SBP)<= 150mmHg;
•5. Glycosylated hemoglobin (HbA1c) should be less than or equal to 7%; for patients with serious complications such as recurrent hypoglycemia, severe microvascular or macrovascular complications, or it is difficult to meet the standard requirements despite adequate treatment, then HbA1c should be less than or equal to 8%;
•6. Patients with ability to read, understand and write research-related materials, and voluntarily comply with all test requirements;
•7. Patients voluntarily participate in the study and written the informed consent form.

•1. Severe infection, anemia, electrolyte imbalance, or acute complications of DM in the previous 4 weeks;
•2. Severe cardiac, cerebral, hepatic, or hemorrhagic diseases, including cerebral infarction, cerebral hemorrhage, transient ischemic attack, myocardial infarction, unstable angina, heart failure, and hepatic inadequacy with aspartate transaminase (AST) or alanine aminotransferase (ALT) levels more than 2 twice the normal upper limit;
•3. Use of corticosteroids or immunosuppressants in the previous 3 months;
•4. Oliguria, anuria, severe edema, massive pleural or peritoneal effusion;
•5. Renal transplantation;
•6. Mental disorders;
•7. Pregnancy or lactation;
•8. Allergy to the trial drugs;
•9. Participation in other clinical studies;
•10. Incomplete understanding of the study, refusal to participate.

发起方

Hospital of Chengdu University of Traditional Chinese Medicine