NCT02063100Unknown4 期
Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis-a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial
Chinese PLA General Hospital43 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 720
- 试验地点
- 43
- 主要终点
- changes of 24 hours proteinuria after the treatment
研究概览
简要总结
-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •secondary nephropathy
- •Take the glucocorticoid,immunosuppressants and Tripterygium drug in the last 12 months
- •Take other Chinese patent medicine and decoction which can reduce proteinuria in the last 2 weeks
- •Take renin-angiotensin system blockers in last 4 weeks
- •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
- •Allergic predisposition or known to be allergic to the drug composition
- •Blood presser <90/60mmHg
- •With unilateral or bilateral renal artery stenosis
- •With mental disorders and poor compliance
- •Be suspected or confirmed with alcohol, drug abuse history
- •Be participating in another clinical study at the same period
研究组 & 干预措施
Shenyankangfu tablets and Losartan potassium 100mg
Experimental
干预措施: Shenyankangfu tablets and Losartan potassium 100mg (Drug)
Shenyankangfu tablets and Losartan potassium 50mg
Experimental
干预措施: Shenyankangfu tablets and Losartan potassium 50mg (Drug)
Losartan potassium 50mg
Experimental
干预措施: Losartan potassium 50mg (Drug)
Shenyankangfu tablets
Experimental
干预措施: Shenyankangfu tablets (Drug)
Losartan potassium 100mg
Experimental
干预措施: Losartan potassium 100mg (Drug)
结局指标
主要结局
changes of 24 hours proteinuria after the treatment
时间窗: 0,4,8,12,24,36,48 weeks after the enrollment
次要结局
- changes of Traditional Chinese Medicine syndrome scores after the treatment(0,4,8,12,24,36,48 weeks after the enrollment)
- changes of serum creatinine after treatment(0,4,8,12,24,36,48 weeks after the enrollment)
- changes of eGFR after the treatment(0,4,8,12,24,36,48 weeks after the enrollment)
研究者
Chen Xiangmei
Professor
Chinese PLA General Hospital
研究点 (43)
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