Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 1
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,472
- 试验地点
- 5
- 主要终点
- The incidence of end-stage renal disease
研究概览
简要总结
In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;
- •2 18-80 years old, regardless of gender ;
- •3 eGFR > 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
- •4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
- •5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
- •6 blood pressure ≤ 160 / 100mmHg ;
- •7 to sign the informed consent ;
排除标准
- •1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;
- •2 patients with a history of recurrent genitourinary tract infection ;
- •3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
- •4 currently in pregnancy, lactation, or pregnancy plan women ;
- •5 Patients with type 1 diabetes.
- •6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.
结局指标
主要结局
The incidence of end-stage renal disease
时间窗: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
dialysis, transplantation or glomerular filtration rate ( eGFR ) \< 15ml / ( min · 1.73m2 )
次要结局
- Estimate the change value of glomerular filtration rate ( eGFR ) level, slope(Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years)
- Incidence of renal composite outcome indicators(Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years)
- Changes of urinary protein creatinine ratio(Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years)
- Changes of 24-hour urinary protein level(Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years)
- Chinese medicine syndrome scores(Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years)
研究者
Liu Hongfang
Chief Physician
Dongzhimen Hospital, Beijing