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| Name | Class |
|---|---|
| Hospital Sao Rafael | OTHER |
| Alagoas State University of Health Science , Maceió , Brazil. | UNKNOWN |
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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.
Randomized open-label cross-over trial to investigate impact of Brazilian green propolis extract on inflammation in hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propolis Period | Experimental | Hemodialysis patients will be under regular treatment of their comorbidities and using Propolis. |
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| Control Period | Experimental | Hemodialysis patients will be under regular treatment of their comorbidities, but without using Propolis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propolis Period (Green Propolis 250mg/day) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in serum level of alanine aminotransferase, aspartate aminotransferase, amylase and creatine kinase during the study, from baseline to end of study periods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcelo Augusto Duarte Silveira | Salvador | Estado de Bahia | 41820-340 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25607548 | Background | Teles F, da Silva TM, da Cruz Junior FP, Honorato VH, de Oliveira Costa H, Barbosa AP, de Oliveira SG, Porfirio Z, Liborio 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. | |
| 28910789 |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective, open-label, proof-of-concept, single-center. Each patient served as their own control.
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| Control Period | Other | In the control period they will only follow standard treatment for their comorbidities. |
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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 |
| 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 |
| 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. |
| 31023272 | Result | 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 Nephrol. 2019 Apr 25;20(1):140. doi: 10.1186/s12882-019-1337-7. |
| 30281126 | Result | 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. |
| 36457860 | Derived | Duarte Silveira MA, Malta-Santos H, Reboucas-Silva J, Teles F, Batista Dos Santos Galvao E, Pinto de Souza S, Dantas Dutra FR, Dantas Gomes MM, Teixeira MB, Miranda Rebelo da Conceicao LF, Nascimento CS, Vasques Nonaka CK, Cezar RS, Pena Batista PB, Berretta AA, Borges VM, da Hora Passos R. Effects of Standardized Brazilian Green Propolis Extract (EPP-AF(R)) on Inflammation in Haemodialysis Patients: A Clinical Trial. Int J Nephrol. 2022 Nov 22;2022:1035475. doi: 10.1155/2022/1035475. eCollection 2022. |