Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,500
- 试验地点
- 13
- 主要终点
- 24-hour urinary protein excretion
研究概览
简要总结
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
详细描述
Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.
Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary glomerulonephritis or diabetic nephropathy;
- •Aged from 18 to 70 years，male or female
- •GFR≥45ml/min/1.73㎡
- •0.5g≤24 hours proteinuria≤3.0g
- •glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
- •Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
- •Obtain the agreement of patients or their guardians, and signed informed consent file
排除标准
- •Secondary nephropathy
- •People allergic to Shenyankangfu tables
- •Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
- •Pregnant or lactating women
- •Be participating in another clinical study at the same period
研究组 & 干预措施
Shenyan kangfu Tablets
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
干预措施: Shenyan Kangfu Tablet (Drug)
结局指标
主要结局
24-hour urinary protein excretion
时间窗: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
次要结局
- Glomerular filtration rate(Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times)
- Serum creatinine(Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times)
- Albumin(Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times)
- Glycated hemoglobin(Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times)
- Symptom scores(Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times)
研究者
Chen Xiangmei
professor
Chinese PLA General Hospital