Status:
UNKNOWN
Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy
Lead Sponsor:
The First Affiliated Hospital of Dalian Medical University
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic neph...
Detailed Description
The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the t...
Eligibility Criteria
Inclusion
- Patients diagnosed as diabetic nephropathy
- TCM syndrome differentiation is Qi deficiency and blood stasis type
- Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR\<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h
- The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Exclusion
- Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period
- Urinary tract infection (leukocytes in urinary sediment \> 5 / HP)
- Serum potassium \> 5.5 mmol/L
- Serum albumin \< 30g/L
- Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
- Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)
- Participating in another clinical trial
- Investigators do not think it suitable for a participant to join this study
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05418465
Start Date
January 26 2022
End Date
December 31 2022
Last Update
June 14 2022
Active Locations (1)
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1
The First Affiliated Hospital of Dalian medical university
Dalian, Liaoning, China, 116011