| Trial ID: | L0638 |
| Source ID: | NCT04072341
|
| Associated Drug: |
Propolis Period (Green Propolis 250mg/Day)
|
| Title: |
Effects of Green Propolis Extract (EPP-AF) on Inflammation in Hemodialysis Patients.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease Requiring Chronic Dialysis
|
| Interventions: |
DRUG: Propolis Period (Green Propolis 250mg/day)|OTHER: Control Period
|
| Outcome Measures: |
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|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|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
|
| Sponsor/Collaborators: |
Sponsor: University of Sao Paulo General Hospital | Collaborators: Hospital Sao Rafael|Alagoas State University of Health Science , Maceió , Brazil.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-08-01
|
| Completion Date: |
2020-01-30
|
| Results First Posted: |
|
| Last Update Posted: |
2022-05-18
|
| Locations: |
Marcelo Augusto Duarte Silveira, Salvador, Bahia, 41820-340, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT04072341
|
