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

Phase 1

Completed

• Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Drug: Propolis Period (Green Propolis 250mg/day); Other: Control Period

• Registration Number: NCT04072341
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Primary Completion: 2019-12-15
• Study Completion: 2020-01-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age over 18 years;
• Male or female on hemodialysis for at least 1 month.

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Propolis Period	Propolis Period (Green Propolis 250mg/day)	Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis.
Control Period	Control Period	Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis.

Primary Outcome Measures

Name	Time	Method
Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.	8 weeks	Change in high sensitivity C-reactive protein from baseline to end of study periods.

Secondary Outcome Measures

Name	Time	Method
Change in serum level of Interleukin-1 Beta from baseline to end of study periods.	8 weeks	Change in Interleukin-1 Beta from baseline to end of study periods.
Percentage of participants with adverse events during the study.	8 weeks	We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.
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	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.

Trial Locations

Locations (1)

Marcelo Augusto Duarte Silveira; 🇧🇷 Salvador, Bahia, Brazil