ITMCTR2200006505
Not Yet Recruiting
Phase 1
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 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- onghua Hospital Shanghai University of Traditional Chinese Medicine
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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