Clinical Study on the Treatment of Diabetic Kidney Diseas... | NCT06176599

ID	Type	Description	Link
YXLL-KY-2023(137)	Other Identifier	The First Affiliated Hospital of Shandong First Medical University

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shenxiao Yuning decoction	Experimental	Diabetes education control of blood glucose; ③Control blood lipids； Control blood pressure； ⑤Other symptomatic treatment； ⑥Shenxiao Yuning decoction：Astragalus 30g, Radix Pseudostellariae 15g, Rehmannia glutinosa 15g, Rhodiola rosea 12g，Cimicifuga 15g，Cuttlebone 15g，Poria 15g，Cicada degeneration 9g，Rheum palmatum 6g. Usage: Decoct by the Traditional Chinese Medicine Pharmacy of the First Affiliated Hospital of Shandong First Medical University. Put 14 doses of Chinese medicine into the decoction bag, then put it into the automatic decoction machine, add 8 L of water and soak for 30 minutes, follow the standard decoction process Decoct 28 bags of Chinese medicine liquid, each bag is 200ml. Take 200ml warmly half an hour after breakfast and dinner.	Drug: Shenxiao Yuning decoction Drug: Symptomatic treatment
Symptomatic treatment	Active Comparator	Diabetes education: all study participants were given dietary guidance for diabetic nephropathy, low-fat, high-quality, low-protein diet, and restricted sodium intake; maintain emotional stability, quit smoking and alcohol, and exercise appropriately; ② control of blood glucose: all study participants routinely received hypoglycaemic treatment, hypoglycaemic measures are not limited (including oral hypoglycaemic drugs or insulin injection); (iii) Control of lipids: study participants with substandard lipids routinely receive lipid-lowering treatment; (iv) Control of blood pressure: those with blood pressure &gt;140/90 mmHg should be treated with antihypertensive drugs to control blood pressure, and antihypertensive measures are not limited (CCB class, ACEI or ARB class, α, β-blockers, diuretics, etc.); ⑤ Other symptomatic treatment.	Drug: Symptomatic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shenxiao Yuning decoction	Drug	Astragalus 30g, Radix Pseudostellariae 15g, Rehmannia glutinosa 15g, Rhodiola rosea 12g，Cimicifuga 15g，Cuttlebone 15g，Poria 15g，Cicada degeneration 9g，Rheum palmatum 6g.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Urinary α1-MG	Charge patients for random urine measurements Urinary α1-MG	0 week，4 weeks
Urinary β2-MG	Collect random urine measurements from patients Urinary β2-MG

Eligibility Module

Eligibility 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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases