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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Kidney Disease Requiring Chronic Dialysis

Intervention / Treatment
-----------------
* Drug: Propolis Period (Green Propolis 250mg/day)
* Other: Control Period


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propolis Period<br>Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis. | Drug: Propolis Period (Green Propolis 250mg/day)<br>* 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.<br>* Other names: Standard treatment for their comorbidities.;|
| Experimental: Control Period<br>Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis. | Other: Control Period<br>* In the control period they will only follow standard treatment for their comorbidities.<br>* Other names: Standard treatment for their comorbidities.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Propolis, High-sensitivity C-reactive protein, Hemodialysis