Clinical effect and mechanism of Shen'an decoction in the treatment of diabetic kidney disease: a randomized controlled clinical study protocol
- Conditions
- Diabetic Nephropathy
- Registration Number
- ITMCTR2100005116
- Lead Sponsor
- Changchun University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.At the same time, it meets the diagnostic criteria and syndrome differentiation criteria of Chinese medicine, and the diagnostic criteria of Western medicine for diabetic nephropathy;
2.The gender is not limited, and the aged 18 to 65 years;
3.HbA1c<=7%, for patients with severe complications such as recurrent hypoglycemia, severe microvascular or macrovascular complications, or patients who cannot meet the standard requirements after adequate treatment, HbA1c<=8%.
4.Control blood pressure below 130/80mmHg;
5.The patient knows and voluntarily participates in the trial study and signs the consent form, and has good compliance.
1.Patients with mental illness who cannot cooperate with treatment and cannot follow the doctor's instructions to receive treatment on time;
2.Patients with recent acute complications and co-infection;
3.Women who are pregnant or breastfeeding or who are about to conceive;
4.People who are prone to allergies or are allergic to test drugs;
5.Patients who have undergone hemodialysis and kidney transplantation;
6.Patients with acute metabolic dysfunction complications such as diabetic ketoacidosis and hyperosmolar coma in the past month;
7.Suffer from other primary or secondary kidney diseases, or other diseases that can cause increased urine protein.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rine protein was quantified at 24h;
- Secondary Outcome Measures
Name Time Method Serum metabolomics;Serum creatinine;High-density lipoprotein;Fasting blood-glucose;Traditional Chinese medicine symptom scores;Total cholesterol;Low-density lipoprotein;Glomerular filtration rate;Glycosylated hemoglobin;Triglycerides;2h postprandial blood glucose;