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.
Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Randomized, cross-over, open-label. Patients will go through two 4 week periods with 1 week washout between them. During the intervention period will use 250mg of green Propolis per day. In the control period they will only follow standard treatment for their comorbidities.
In the control period they will only follow standard treatment for their comorbidities.
Marcelo Augusto Duarte Silveira
Salvador, Estado de Bahia, Brazil
Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.
Change in high sensitivity C-reactive protein from baseline to end of study periods.
Time frame: 8 weeks
Change in serum level of Interleukin-1 Beta from baseline to end of study periods.
Change in Interleukin-1 Beta from baseline to end of study periods.
Time frame: 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.
To evaluate the safety of propolis use in hemodialysis patients. Measurement of changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study.
Time frame: 8 weeks
Percentage of participants with adverse events during the study.
We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.
Time frame: 8 weeks
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