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

NCT04072341 | Completed Phase 1 DMC

• 1 other identifier: Hospital São Rafael S.A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Inflammation; Propolis; High-sensitivity C-reactive protein; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in serum level of 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.

  8 weeks

• Percentage of participants with adverse events during the study.

  8 weeks

Study Arms (2)

Propolis Period

EXPERIMENTAL

Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis.

Drug: Propolis Period (Green Propolis 250mg/day)

Control Period

EXPERIMENTAL

Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis.

Other: Control Period

Interventions

Propolis Period (Green Propolis 250mg/day) DRUG

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.

Also known as: Standard treatment for their comorbidities.

Propolis Period

Control Period OTHER

In the control period they will only follow standard treatment for their comorbidities.

Also known as: Standard treatment for their comorbidities.

Control Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Hospital Sao Rafael: collaborator
• Alagoas State University of Health Science , Maceió , Brazil.: collaborator

Study Sites (1)

Marcelo Augusto Duarte Silveira

Salvador, Estado de Bahia, 41820-340, Brazil

Location

Related Publications (5)

• 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.

  PMID: 25607548 BACKGROUND

• 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.

  PMID: 28910789 BACKGROUND

• 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.

  PMID: 31023272 RESULT

• 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.

  PMID: 30281126 RESULT

• Duarte Silveira MA, Malta-Santos H, Reboucas-Silva J, Teles F, Batista Dos Santos Galvao E, Pinto de Souza S, Dantas Dutra FR, Dantas Gomes MM, Teixeira MB, Miranda Rebelo da Conceicao LF, Nascimento CS, Vasques Nonaka CK, Cezar RS, Pena Batista PB, Berretta AA, Borges VM, da Hora Passos R. Effects of Standardized Brazilian Green Propolis Extract (EPP-AF(R)) on Inflammation in Haemodialysis Patients: A Clinical Trial. Int J Nephrol. 2022 Nov 22;2022:1035475. doi: 10.1155/2022/1035475. eCollection 2022.

  PMID: 36457860 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: December 15, 2019
• Study Completion: January 30, 2020
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)