drugset / Trial / NCT04072341
Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients.
Phase 1/2
Completed
40 enrolled
University of Sao Paulo General Hospital
Alagoas State University of Health Science , Maceió , Brazil. · collabHospital Sao Rafael · collab
RandomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2019-12-15
- Completion
- 2020-01-30
Publications
- 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.
- Background 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.
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PROPOLIS WAX | Traditional medicine (herbal / TCM) | 250 mg | — |