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

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Treatments: Drug: Propolis Period (Green Propolis 250mg/day); Other: Control Period

Study type: Interventional

Funder types: Other

Identifiers

NCT04072341

Hospital São Rafael S.A

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Propolis Period

Experimental group

Description:

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

Treatment:

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

Control Period

Experimental group

Description:

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

Treatment:

Other: Control Period