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

Chronic Kidney Disease Requiring Chronic Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072341
• Other study ID #: Hospital São Rafael S.A
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: May 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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:
• Control Period
In the control period they will only follow standard treatment for their comorbidities.

Locations

Country	Name	City	State
Brazil	Marcelo Augusto Duarte Silveira	Salvador	Bahia

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Alagoas State University of Health Science , Maceió , Brazil., Hospital Sao Rafael

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Cobo G, Lindholm B, Stenvinkel P. Chronic inflammation in end-stage renal disease and dialysis. Nephrol Dial Transplant. 2018 Oct 1;33(suppl_3):iii35-iii40. doi: 10.1093/ndt/gfy175. Review. — View Citation

Dai L, Golembiewska E, Lindholm B, Stenvinkel P. End-Stage Renal Disease, Inflammation and Cardiovascular Outcomes. Contrib Nephrol. 2017;191:32-43. doi: 10.1159/000479254. Epub 2017 Sep 14. Review. — View Citation

Silveira MAD, Teles F, Berretta AA, Sanches TR, Rodrigues CE, Seguro AC, Andrade L. Effects of Brazilian green propolis on proteinuria and renal function in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled trial. BMC Ne — View Citation

Teles F, da Silva TM, da Cruz Júnior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfírio Z, Libório AB, Borges RL, Fanelli C. Brazilian red propolis attenuates hypertension and renal damage in 5/6 renal ablation model. PLoS One. 2015 Jan 21;10(1):e0116535. doi: 10.1371/journal.pone.0116535. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum level of High-sensitivity C-reactive protein from baseline to end of study periods.	Change in high sensitivity C-reactive protein from baseline to end of study periods.	8 weeks
Secondary	Change in serum level of Interleukin-1 Beta from baseline to end of study periods.	Change in Interleukin-1 Beta from baseline to end of study periods.	8 weeks
Secondary	Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods.	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.	8 weeks
Secondary	Percentage of participants with adverse events during the study.	We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.	8 weeks