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

NCT06176599 | Unknown

• 1 other identifier: YXLL-KY-2023(137)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease

Keywords

Shenxiao Yuning Decoction; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 (14)

• Urinary α1-MG

  0 week，4 weeks

• Urinary β2-MG

  0 week，4 weeks

• Scr

  0 week，4 weeks

• BUN

  0 week，4 weeks

• uric acid

  0 week，4 weeks

Study Arms (2)

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 \>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

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.

Shenxiao Yuning decoction

Symptomatic treatment DRUG

(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.

Shenxiao Yuning decoction; Symptomatic treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lin Liao: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Endocrinology Department

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 19, 2023
• Study Start: September 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

CN (1)