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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Kidney Disease
• Intervention / Treatment: Drug: Shenxiao Yuning decoction; Drug: Symptomatic treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shenxiao Yuning decoction; Diabetes educationcontrol 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; Astragalus 30g, Radix Pseudostellariae 15g, Rehmannia glutinosa 15g, Rhodiola rosea 12g，Cimicifuga 15g，Cuttlebone 15g，Poria 15g，Cicada degeneration 9g，Rheum palmatum 6g.; Drug: 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, α, β-blockers, diuretics, etc.); ⑤ Other symptomatic treatment.
Active Comparator: Symptomatic treatment; 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 >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; (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, α, β-blockers, diuretics, etc.); ⑤ Other symptomatic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	0 week，4 weeks
Scr	Collect the patient's fasting blood to measure Scr	0 week，4 weeks
BUN	Collect the patient's fasting blood to measure BUN	0 week，4 weeks
uric acid	Collect the patient's fasting blood to measure uric acid	0 week，4 weeks
Cys-C	Collect the patient's fasting blood to measure Cys-C	0 week，4 weeks
fasting plasma glucose	Collect the patient's fasting blood to measure fasting plasma glucose	0 week，4 weeks
HbA1c	Collect the patient's fasting blood to measure HbA1c	0 week，4 weeks
total cholesterol	Collect the patient's fasting blood to measure total cholesterol	0 week，4 weeks
Triglyceride	Collect the patient's fasting blood to measure Triglyceride	0 week，4 weeks
HDL	Collect the patient's fasting blood to measure HDL	0 week，4 weeks
LDL	Collect the patient's fasting blood to measure LDL	0 week，4 weeks
albumin	Collect the patient's fasting blood to measure albumin	0 week，4 weeks
Urinary microalbumin/urinary creatinine	Collect random urine samples from patients to measure urine microalbumin/urinary creatinine（mg/g）	0 week，4 weeks

Collaborators and Investigators

• Sponsor: Lin Liao

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 16, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic Kidney Disease; Shenxiao Yuning Decoction
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Diabetic Nephropathies; Yin Deficiency
• Other Study ID Numbers: YXLL-KY-2023(137) (Other Identifier: The First Affiliated Hospital of Shandong First Medical University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No