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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04072341

Collaborator

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

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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

Aug 1, 2019

Actual Primary Completion Date :

Dec 15, 2019

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods. [8 weeks]
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. [8 weeks]
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. [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.
Percentage of participants with adverse events during the study. [8 weeks]
We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marcelo Augusto Duarte Silveira	Salvador	Bahia	Brazil	41820-340

Sponsors and Collaborators

University of Sao Paulo General Hospital
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