Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis

• Status: Active, not recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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 and Yin deficiency and blood stasis syndrome.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lin Liao

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.