the Clinical Research for Effectivity and Safety of Modified Hu-Lu-Ba-Wan in the treatment of Diabetic Kidney Disease
- Conditions
- Diabetic Kidney Disease
- Registration Number
- ITMCTR1900002456
- Lead Sponsor
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Accord to the western diagnostic criteria for type 2 diabetes, or previous history of diabetes;
2. Phase III DKD standard, the screening and early detection of urinary albumin/creatinine ratio (ACR) are accord with 30 ~ 300 mg/g;
3. Syndrome differentiation of TCM syndrome type is kidney Yang deficiency;
4. Normal serum creatine;
5. After basic treatment, blood glucose was controlled in HbA1c < 8.5%, FPG < 9mmol/L, 2h postprandial blood glucose < 13.0mmol/L, and blood pressure was controlled in < 140/90mmhg.
6. Male and female aged 25-70 years old;
7. Sign informed consent form.
1. Type 1 diabetes;
2. Patients with severe primary cardiovascular and cerebrovascular diseases, liver and kidney dysfunction and hematopoietic system diseases;
3. Infection, severe electrolyte disorder and other aggravating factors which are not controlled or the patients whose conditions are unstable;
4. Excluding patients with a variety of primary and secondary renal diseases and diseases caused by hypertension, heart failure, acidosis and urinary tract infection with increased urinary protein;
5. Mentally ill;
6. Women who are pregnant or preparing for pregnancy or lactation;
7. Patients who need long-term hormone therapy;
8. Hypertension that is difficult to control, or secondary hypertension;
9. The patients who the investigator expects poor compliance or inability to cooperate.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ACR;TCM syndrone score;
- Secondary Outcome Measures
Name Time Method Blood fat;Fasting blood-glucose;eGFR;HbA1c;Urine targeted metabolomics;The number of urinary foot cells and the expressions of pcx-1, nephrin and CD2AP in urinary sediment;