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

Phase 1

• Conditions: Diabetic kidney disease

• Registration Number: ITMCTR2200006505
• Lead Sponsor: onghua Hospital Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour urinary protein quantity;24-hour urinary microalbumin;Glomerular filtration rate;Urinary albumin-creatinine ratio;fasting plasma glucose;