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

Primary Purpose

Chronic Kidney Disease Requiring Chronic Dialysis

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Propolis Period (Green Propolis 250mg/day)

Control Period

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Requiring Chronic Dialysis focused on measuring Inflammation, Propolis, High-sensitivity C-reactive protein, Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Marcelo Augusto Duarte Silveira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Propolis Period

Control Period

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04072341

First Posted

August 26, 2019

Last Updated

May 11, 2022

Sponsor

University of Sao Paulo General Hospital

Collaborators

Hospital Sao Rafael, Alagoas State University of Health Science , Maceió , Brazil.

1. Study Identification

Unique Protocol Identification Number

NCT04072341

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 15, 2019 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

Collaborators

Hospital Sao Rafael, Alagoas State University of Health Science , Maceió , Brazil.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propolis Period

Arm Type

Experimental

Arm Description

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

Arm Title

Control Period

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Propolis Period (Green Propolis 250mg/day)

Other Intervention Name(s)

Standard treatment for their comorbidities.

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control Period

Other Intervention Name(s)

Standard treatment for their comorbidities.

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.

Description

Change in high sensitivity C-reactive protein from baseline to end of study periods.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in serum level of Interleukin-1 Beta from baseline to end of study periods.

Description

Change in Interleukin-1 Beta from baseline to end of study periods.

Time Frame

8 weeks

Title

Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods.

Description

Time Frame

8 weeks

Title

Percentage of participants with adverse events during the study.

Description

We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcelo Silveira, MD, PhD

Organizational Affiliation

Hospital São Rafael S.A

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Flávio Teles, MD, PhD

Organizational Affiliation

Universidade Estadual de Ciências da Saúde de Alagoas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rogério Passos

Organizational Affiliation

Hospital São Rafael S.A

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marcelo Augusto Duarte Silveira

City

Salvador

State/Province

Bahia

ZIP/Postal Code

41820-340

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25607548

Citation

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.

Results Reference

background

PubMed Identifier

28910789

Citation

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.

Results Reference

background

PubMed Identifier

31023272

Citation

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.

Results Reference

result

PubMed Identifier

30281126

Citation

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.

Results Reference

result

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

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