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

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ClinicalTrials.gov Identifier: NCT04072341
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Hospital Sao Rafael
Alagoas State University of Health Science , Maceió , Brazil.
Information provided by (Responsible Party):
Marcelo Augusto Duarte Silveira, University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Requiring Chronic Dialysis Drug: Propolis Period (Green Propolis 250mg/day) Other: Control Period Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized Cross-Over Trial. Each patient served as their own control.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients: a Randomized Cross-over Trial.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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 Name: 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 Name: Standard treatment for their comorbidities.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072341


Contacts
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Contact: Marcelo Silveira +55 71 3408-8000 marceloadsilveira@gmail.com
Contact: Rogerio Passos +55 71 3408-8000 rogerio.passos@hsr.com.br

Locations
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Brazil
Marcelo Augusto Duarte Silveira Recruiting
Salvador, Bahia, Brazil, 41820-340
Contact: Marcelo Silveira, MD, PhD    +55 71 3409-8000    marceloadsilveira@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Hospital Sao Rafael
Alagoas State University of Health Science , Maceió , Brazil.
Investigators
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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 of Results:
Other Publications:
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Responsible Party: Marcelo Augusto Duarte Silveira, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04072341    
Other Study ID Numbers: Hospital São Rafael S.A
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcelo Augusto Duarte Silveira, University of Sao Paulo General Hospital:
Inflammation
Propolis
High-sensitivity C-reactive protein
Hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Inflammation
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Propolis
Anti-Infective Agents