A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dapagliflozin group
Dapagliflozin
干预措施: Dapagliflozin (Drug)
Huangqi Guizhi Wuwu decoction group
Huangqi Guizhi Wuwu decoction
干预措施: Huangqi Guizhi Wuwu decoction (Drug)
结局指标
主要结局
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
时间窗: 12 weeks
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
次要结局
- Change in 24-hour urine protein ration from baseline.(Start of treatment until the end of the treatment for 12 weeks)
研究者
Ming Fang
Chief physician
The First Affiliated Hospital of Dalian Medical University