A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)
Overview
- Phase
- Not Applicable
- Intervention
- Dapagliflozin
- Conditions
- Diabetic Nephropathies
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
- Last Updated
- 3 years ago
Overview
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 nephropathy.
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 treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.
Investigators
Ming Fang
Chief physician
The First Affiliated Hospital of Dalian Medical University
Eligibility Criteria
Inclusion Criteria
- •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
- •6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Exclusion Criteria
- •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
Arms & Interventions
Dapagliflozin group
Dapagliflozin
Intervention: Dapagliflozin
Huangqi Guizhi Wuwu decoction group
Huangqi Guizhi Wuwu decoction
Intervention: Huangqi Guizhi Wuwu decoction
Outcomes
Primary Outcomes
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
Time Frame: 12 weeks
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
Secondary Outcomes
- Change in 24-hour urine protein ration from baseline.(Start of treatment until the end of the treatment for 12 weeks)