Chronic Kidney Disease Requiring Chronic Dialysis
Conditions
Keywords
Inflammation, Propolis, High-sensitivity C-reactive protein, Hemodialysis
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.
Interventions
DRUGPropolis 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.
OTHERControl Period
In the control period they will only follow standard treatment for their comorbidities.
Sponsors
Hospital Sao Rafael
Alagoas State University of Health Science , Maceió , Brazil.
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed