Status:
UNKNOWN
Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis
Lead Sponsor:
Lin Liao
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To explore the therapeutic effect of Shenxiao Yuning Decoction on albuminuria and the improvement of traditional Chinese medicine syndrome in patients with stage III diabetic kidney disease with Qi an...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for albuminuria in type 2 diabetic nephropathy, persistent albuminuria, and 2 consecutive urine microalbumin/creatinine (ACR) \>30mg/g within 3 months;
- The glomerular filtration rate eGPR ≥ 60ml/min/1.73m2, and is required to remain stable during the trial (eGFR decreases ≤25% from the beginning of screening to the second week of follow-up);
- Those who are consistent with the syndrome of diabetes and kidney disease, deficiency of Qi and Yin and blood stasis;
- Gender is not limited, age is 18-75 years old, BMI≤45 kg/m2;
- Glycated hemoglobin (HbA1C) 6-11%, fasting blood glucose (FPG) ≤15 mmol/L;
- Systolic blood pressure/diastolic blood pressure (SBP/DBP) ≤180/100 mmhg (sitting);
- Those who have complete medical records, voluntarily participate in this clinical study, and sign the informed consent form.
Exclusion
- Pregnant and lactating women;
- Acute complications of diabetes such as hypoglycemic coma, diabetic ketosis, lactic acidosis, etc. have recently occurred;
- Those combined with heart failure and myocardial infarction; combined with infections, immune diseases, and malignant tumors; combined with liver diseases (ALT, AST or ALP levels exceed three times the upper limit of normal);
- Male serum creatinine (SCr) ≥1.50 mg/d1 (114.4 μmol/L), or female serum creatinine ≥1.40 mg/dl (106.8 μmol/L);
- Those who are combined with other kidney and renovascular diseases, or those who have other causes such as excessive exercise, heart failure, febrile infections, or urinary tract infections that lead to elevated urinary microalbumin;
- Those who have used nephrotoxic drugs and antioxidants, or used systemic glucocorticoid therapy in the past 2 weeks;
- Those undergoing dialysis or kidney transplantation;
- History of bariatric surgery or other gastrointestinal surgery causing chronic malabsorption within 2 years;
- Persons with drug contraindications: pregnant or lactating women, allergic constitutions, and those allergic to the drugs used in this study;
- Those who are unable to cooperate due to severe mental illness or mental disorder;
- Those who have not signed the informed consent form.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06176599
Start Date
September 1 2022
End Date
June 30 2024
Last Update
December 19 2023
Active Locations (1)
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1
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China, 250014