NCT04072341

Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients.

Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients: a Randomized Cross-over Trial.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis

Interventions

Type	Name	Description
DRUG	Propolis Period (Green Propolis 250mg/day)	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.
OTHER	Control Period	In the control period they will only follow standard treatment for their comorbidities.

Timeline

• Start date: 2019-08-01
• Primary completion: 2019-12-15
• Completion: 2020-01-30
• First posted: 2019-08-28
• Last updated: 2022-05-18

Locations

1 site across 1 country: Brazil