Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.
详细描述
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.
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, Investigator)
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
- •The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
- •TCM is liver kidney yin deficiency syndrome;
- •age 18-70 years old, sex, nationality is not limited;
- •CKD phase 2-4 （89 ml/min>eGFR（EPI Formula）>15ml/min/1.73m2）;
- •24 hour urinary protein≥1g.
排除标准
- •It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
- •It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
- •Acute or progressive glomerulonephritis patients;
- •Severe complications threat to life, such as severe infection;
- •Active hepatitis B and liver function test sustained abnormal;
- •Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
- •Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
- •Gravid or lactation woman;
- •Other clinical trials are being studied;
- •Merger with other serious disease and dysfunction of the organ.
研究组 & 干预措施
WM Group
Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
干预措施: WM (Shentong Granules) (Drug)
WM Group
Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
干预措施: Hormone (prednisone) (Drug)
Hormone Group
Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
干预措施: Hormone (prednisone) (Drug)
结局指标
主要结局
Glomerular filtration rate
时间窗: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
次要结局
- serum Lipid(Half-yearly)
- 24-hour urinary protein excretion(changes from Baseline to 2, 4, 12, 24,36 and 48 weeks)
- serum creatinine(changes from Baseline to 2, 4, 12, 24,36 and 48 weeks)
- TCM syndrome score(changes from Baseline to 2, 4, 12, 24,36 and 48 weeks)