Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.
- •Pathology:upon Lee's grade Ⅲ
- •Age :18-60 years old.
- •Gender and nationality are not limited
- •Chronic Kidney Disease(CKD) Stage 3:（59 ml/min>GFR>30ml/min/1.73m2）
- •24-hour urine protein:≥1.0g.Informed consent
排除标准
- •Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks
- •Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks
- •Patients suffering from acute or rapidly progressive glomerulonephritis
- •Patients continue with active hepatitis B and abnormal liver function tests transaminase
- •Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents
- •Abnormal glucose metabolism, fasting blood glucose more than 6.2mmol/L
- •Pregnancy or breast-feeding women
- •Receiving other clinical trials
- •Associated with other serious diseases and organ dysfunction
- •Combined life-threatening complications such as severe infection
研究组 & 干预措施
Combination Group
Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks
干预措施: Chinese Herb Prescription Granule plus prednisone (Drug)
Placebo
Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Glomerular filtration rate
时间窗: 12 months
Evaluation of renal function indicators
次要结局
- 24 hours urine protein(12 months)
研究者
yueyi deng
Director
Shanghai University of Traditional Chinese Medicine