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临床试验/NCT02766036
NCT02766036已完成2 期

Propolis Effects on Proteinuria and Kidney Function in Patients With Chronic Kidney Disease

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Reducing Proteinuria

研究概览

简要总结

The aim of this study is to determine the impact of Propolis on proteinuria reduction and protection of the glomerular filtration rate in chronic renal failure patients.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18 years;
  • less than 90 years;
  • glomerular filtration rate between 25 and 70 ml / min;
  • proteinuria in the urine 24 hours more than 300 mg or protein / creatinina in isolated urine greater than 0.3g / g or microalbuminuria (albumin / creatinine ratio) between 30-300 mg / g.

排除标准

  • Pregnants;
  • Neoplasia carrier;
  • Renal transplant patients;
  • Patients who refuse to participate in the study.
  • Glomerulopathy on Immunosuppression

研究组 & 干预措施

Propolis

Active Comparator

Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician. Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses.

干预措施: Propolis (Drug)

Placebo

Placebo Comparator

Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician. Patients will receive 500 mg / day of the propolis-placebo in the form of tablets split in two daily doses.

干预措施: Placebo (Drug)

结局指标

主要结局

Reducing Proteinuria

时间窗: One year

Reduction from baseline proteinuria.

次要结局

  • Protection of the glomerular filtration rate(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo Augusto Duarte Silveira

Principal Investigator

University of Sao Paulo General Hospital

研究点 (1)

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