Diabetic Kidney Disease Clinical Trial
— SXYNTOfficial title:
Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis
Verified date | December 2023 |
Source | Qianfoshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Lin Liao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effective rate | Clinical control: Urine routine examination of urine protein qualitative turn negative, ACR normal. Apparent effect: ACR reduction =50%. Effective: ACR reduction =15%, but less than =50%. Ineffective No improvement in clinical manifestations and laboratory parameters. | 0 week,4 weeks | |
Secondary | Urinary a1-MG | Charge patients for random urine measurements Urinary a1-MG | 0 week,4 weeks | |
Secondary | Urinary ß2-MG | Collect random urine measurements from patients Urinary ß2-MG | 0 week,4 weeks | |
Secondary | Scr | Collect the patient's fasting blood to measure Scr | 0 week,4 weeks | |
Secondary | BUN | Collect the patient's fasting blood to measure BUN | 0 week,4 weeks | |
Secondary | uric acid | Collect the patient's fasting blood to measure uric acid | 0 week,4 weeks | |
Secondary | Cys-C | Collect the patient's fasting blood to measure Cys-C | 0 week,4 weeks | |
Secondary | fasting plasma glucose | Collect the patient's fasting blood to measure fasting plasma glucose | 0 week,4 weeks | |
Secondary | HbA1c | Collect the patient's fasting blood to measure HbA1c | 0 week,4 weeks | |
Secondary | total cholesterol | Collect the patient's fasting blood to measure total cholesterol | 0 week,4 weeks | |
Secondary | Triglyceride | Collect the patient's fasting blood to measure Triglyceride | 0 week,4 weeks | |
Secondary | HDL | Collect the patient's fasting blood to measure HDL | 0 week,4 weeks | |
Secondary | LDL | Collect the patient's fasting blood to measure LDL | 0 week,4 weeks | |
Secondary | albumin | Collect the patient's fasting blood to measure albumin | 0 week,4 weeks | |
Secondary | Urinary microalbumin/urinary creatinine | Collect random urine samples from patients to measure urine microalbumin/urinary creatinine(mg/g) | 0 week,4 weeks |
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