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

Diabetic Kidney Disease Clinical Trial

— SXYNT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06176599
• Other study ID #: YXLL-KY-2023(137)
• Secondary ID: YXLL-KY-2023(137
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Yin Deficiency

Intervention

Drug:
• Shenxiao 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.
• Symptomatic treatment
(i) 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; (ii) 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 >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, a, ß-blockers, diuretics, etc.); ? Other symptomatic treatment.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Lin Liao

Country where clinical trial is conducted

China, 

Outcome

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