None listed
Conditions
Interventions
Single-arm research Group:Basic Western medical treatment + acupoint embedding therapy
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The age limit for enrollment is 18 to 80 years old; 2. Meet the diagnostic criteria for type 2 DKD; At least 12 weeks before the visit, the patient should receive AECI or ARB treatment. For drugs with clear renal protective effects such as SGLT2i, MRA, and GLP-1RA, the medication regimen should also be determined within the screening period and the treatment should be carried out for more than 12 weeks. During the subsequent treatment period, try to keep the dosage and type of medication stable as much as possible. 4.30=eGFR < 90 mL/min/1.73m2; 5.300 < UACR=5000mg/g; 6. It meets the diagnostic criteria for spleen and kidney qi deficiency syndrome in traditional Chinese medicine (reference for traditional Chinese medicine diagnostic criteria: For spleen and kidney qi deficiency syndrome, refer to the "Technical Guidelines for Clinical Research of New Traditional Chinese Medicine for Diabetic Kidney Disease" (2020 Edition)). 7. Be patient and able to understand and follow the guidance related to study. 9. For women with fertility potential, if the prenatal test is negative during the screening visit and they agree to take appropriate contraceptive measures 10. Understand and abide by the research process, participate voluntarily, and sign the informed consent form (the informed consent form should be signed by the individual or their guardian). 11. Those who can accept and tolerate this acupoint embedding treatment; Symptoms of spleen and kidney qi deficiency type: shortness of breath and fatigue, soreness and weakness in the waist and knees, sticky stools, reduced urine output and edema, or frequent nocturia and sallow complexion. The tongue is pale and plump with tooth marks, the coating is thin and white, and the pulse is deep and fine.
Exclusion criteria
Exclusion criteria: 1Patients with type 1 diabetes; 2. People with allergic constitutions keloid-prone constitutions or those who have rejection reactions to the material of the buried thread; 3. There is infection at the acupoint burial site the skin is damaged or ulcerated and the healing is poor; 4. Patients with mental disorders such as anxiety and depression; 5. Patients with diabetic peripheral neuropathy and diabetic foot; 6. Known significant non-diabetic kidney diseases including various primary glomerular diseases secondary kidney diseases and clinically relevant renal artery stenosis. 7. At the initial examination the UACR was >5000mg/g (=565mg /mmol). 8. At the initial examination HbAlc>12%. 9. Uncontrolled arterial hypertension with mean sitting systolic blood pressure (SBP) =170 mmHg or mean sitting diastolic blood pressure (DBP) =110 mmHg at the initial examination. 10. The average systolic blood pressure at the initial examination was less than 90 MMHG. 11. Serum potassium was greater than 4.8mm/ L. 12 Stroke transient ischemic attack acute coronary syndrome or hospitalization due to HF deterioration 30 days before the screening visit. 13.12 weeks of PCI or CABG or valve repair/replacement surgery or planning to undergo any of the above surgeries after grouping; Myocardial infarction unstable angina pectoris stroke or transient ischemic attack within 14.12 weeks; 15. Undergo dialysis for acute renal failure within 12 weeks before the running-in visit. 16. Active malignant tumors or other diseases that limit life expectancy by less than 12 months. 17. During the study period if one is pregnant breastfeeding planning to become pregnant or undergoing another clinical trial drug study. 18. Traditional Chinese medicine diagnosis does not conform to the type of patients with deficiency of spleen and kidney qi; 19. When screening AST or ALT should be greater than twice the normal upper limit; Or total bilirubin > 1.5 times; Patients who have participated in other drug clinical trials or are currently participating in other clinical trials within one month prior to participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UACR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Four items of blood Lipid;eGFR;FBG,HbA1C;TCM syndrome points; | — |
Countries
zhongguo
Contacts
Public Contactfanying
Shanghai Sixth People's Hospital
Outcome results
None listed