Clinical trial NCT06176599: Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis
Official title: Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Kidney Disease
Keywords: Shenxiao Yuning Decoction
Diabetic Kidney Disease
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 and Yin deficiency and blood stasis syndrome.


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.

Primary outcomes:
measure: Effective rate
timeFrame: 0 week，4 weeks
Secondary outcomes:
measure: Urinary α1-MG
timeFrame: 0 week，4 weeks
measure: Urinary β2-MG
timeFrame: 0 week，4 weeks
measure: Scr
timeFrame: 0 week，4 weeks
measure: BUN
timeFrame: 0 week，4 weeks
measure: uric acid
timeFrame: 0 week，4 weeks
measure: Cys-C
timeFrame: 0 week，4 weeks
measure: fasting plasma glucose
timeFrame: 0 week，4 weeks
measure: HbA1c
timeFrame: 0 week，4 weeks
measure: total cholesterol
timeFrame: 0 week，4 weeks
measure: Triglyceride
timeFrame: 0 week，4 weeks
measure: HDL
timeFrame: 0 week，4 weeks
measure: LDL
timeFrame: 0 week，4 weeks
measure: albumin
timeFrame: 0 week，4 weeks
measure: Urinary microalbumin/urinary creatinine
timeFrame: 0 week，4 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: