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Completed

NCT Number: NCT04072341

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

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.

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Key information

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Marcelo Augusto Duarte Silveira

Salvador, Estado de Bahia, 41820-340, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Other names: Standard treatment for their comorbidities.

Control period

Other

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

Other names: Standard treatment for their comorbidities.

Primary outcomes

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

    Time frame: 8 weeks

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

Secondary outcomes

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

    Time frame: 8 weeks

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

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

    Time frame: 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.

  3. Percentage of participants with adverse events during the study.

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 28, 2019
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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