Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients: a Randomized Cross-over Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.
研究概览
简要总结
End-stage chronic kidney disease is associated with the condition of chronic inflammation. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, and anti-oxidant properties. The aim of this study was to evaluate the impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
详细描述
Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years;
- •Male or female on hemodialysis for at least 1 month.
排除标准
- •Pregnant Woman;
- •Carriers of active neoplasms;
- •Patients undergoing kidney transplantation during the study;
- •Infection during the study;
- •Patients who underwent parathyroidectomy during the study;
- •Patient using immunosuppressive drugs;
- •Allergy to propolis or any of its components;
研究组 & 干预措施
Propolis Period
Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis.
干预措施: Propolis Period (Green Propolis 250mg/day) (Drug)
Control Period
Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis.
干预措施: Control Period (Other)
结局指标
主要结局
Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.
时间窗: 8 weeks
Change in high sensitivity C-reactive protein from baseline to end of study periods.
次要结局
- Change in serum level of Interleukin-1 Beta from baseline to end of study periods.(8 weeks)
- Percentage of participants with adverse events during the study.(8 weeks)
- Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods.(8 weeks)
研究者
Marcelo Augusto Duarte Silveira
Principal Investigator
University of Sao Paulo General Hospital