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.

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.

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41820-340
      • Marcelo Augusto Duarte Silveira

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propolis Period; Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis.	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 Names: Standard treatment for their comorbidities.
Experimental: Control Period; Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis.	Other: Control Period; In the control period they will only follow standard treatment for their comorbidities.; 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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Hospital Sao Rafael; Alagoas State University of Health Science , Maceió , Brazil.
• Investigators: Principal Investigator: Marcelo Silveira, MD, PhD, Hospital São Rafael S.A; Principal Investigator: Flávio Teles, MD, PhD, Universidade Estadual de Ciências da Saúde de Alagoas; Principal Investigator: Rogério Passos, Hospital São Rafael S.A

Publications and helpful links

General Publications

• Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7.
• Teles F, da Silva TM, da Cruz Junior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfirio Z, Liborio AB, Borges RL, Fanelli C. Brazilian red propolis attenuates hypertension and renal damage in 5/6 renal ablation model. PLoS One. 2015 Jan 21;10(1):e0116535. doi: 10.1371/journal.pone.0116535. eCollection 2015.
• Dai L, Golembiewska E, Lindholm B, Stenvinkel P. End-Stage Renal Disease, Inflammation and Cardiovascular Outcomes. Contrib Nephrol. 2017;191:32-43. doi: 10.1159/000479254. Epub 2017 Sep 14.
• Cobo G, Lindholm B, Stenvinkel P. Chronic inflammation in end-stage renal disease and dialysis. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii35-iii40. doi: 10.1093/ndt/gfy175.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Hemodialysis; Propolis; High-sensitivity C-reactive protein
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Anti-Infective Agents; Propolis
• Other Study ID Numbers: Hospital São Rafael S.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No