A Phase 2 interventional study of Propolis and Placebo in Chronic Kidney Diseases, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
The aim of this study is to determine the impact of Propolis on proteinuria reduction and protection of the glomerular filtration rate in chronic renal failure patients.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 32 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician. Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses.
Drug: Propolis
Patients will continue to receive standard treatment for their comorbidities, determined by the attending physician. Patients will receive 500 mg / day of the propolis-placebo in the form of tablets split in two daily doses.
Drug: Placebo
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
Reducing Proteinuria
Reduction from baseline proteinuria.
Time frame: One year
Protection of the glomerular filtration rate
Maintaining glomerular filtration rate or inferior reduction to 5 ml per minute per 1.73 m2 of body-surface area from baseline.
Time frame: One year
Plan to share: Yes — The data will be evaluated monthly by researchers at the scientific meetings of the department. Data from this study will be considered joint property of the parties involved. Researchers are, however, responsible for committing to make public the results.
Supporting information: Study protocol
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo General Hospital