Propolis Effects in Patients With Chronic Kidney Disease
NCT ID: NCT02766036
Last Updated: 2018-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2016-12-01
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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 extract in the form of tablets split in two daily doses.
Propolis
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
Placebo
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.
Placebo
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
Interventions
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Propolis
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
Placebo
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
Eligibility Criteria
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Inclusion Criteria
* less than 90 years;
* glomerular filtration rate between 25 and 70 ml / min;
* proteinuria in the urine 24 hours more than 300 mg or protein / creatinina in isolated urine greater than 0.3g / g or microalbuminuria (albumin / creatinine ratio) between 30-300 mg / g.
Exclusion Criteria
* Neoplasia carrier;
* Renal transplant patients;
* Patients who refuse to participate in the study.
* Glomerulopathy on Immunosuppression
18 Years
90 Years
ALL
Yes
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Marcelo Augusto Duarte Silveira
Principal Investigator
Principal Investigators
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General Hospital
Role: STUDY_CHAIR
University of Sao Paulo
Locations
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University of Sao Paulo General Hospital
São Paulo, , Brazil
Countries
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References
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Fujihara CK, DE Lourdes Noronha I, Malheiros DMAC, Antunes GR, DE Oliveira IB, Zatz R. Combined mycophenolate mofetil and losartan therapy arrests established injury in the remnant kidney. J Am Soc Nephrol. 2000 Feb;11(2):283-290. doi: 10.1681/ASN.V112283.
da Costa MF, Liborio AB, Teles F, Martins Cda S, Soares PM, Meneses GC, Rodrigues FA, Leal LK, Miron D, Silva AH, Martins AM. Red propolis ameliorates ischemic-reperfusion acute kidney injury. Phytomedicine. 2015 Aug 15;22(9):787-95. doi: 10.1016/j.phymed.2015.03.017. Epub 2015 Apr 12.
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.
Machado JL, Assuncao AK, da Silva MC, Dos Reis AS, Costa GC, Arruda Dde S, Rocha BA, Vaz MM, Paes AM, Guerra RN, Berretta AA, do Nascimento FR. Brazilian green propolis: anti-inflammatory property by an immunomodulatory activity. Evid Based Complement Alternat Med. 2012;2012:157652. doi: 10.1155/2012/157652. Epub 2012 Dec 19.
Himmelfarb J. Linking oxidative stress and inflammation in kidney disease: which is the chicken and which is the egg? Semin Dial. 2004 Nov-Dec;17(6):449-54. doi: 10.1111/j.0894-0959.2004.17605.x.
Inker LA, Coresh J, Levey AS, Tonelli M, Muntner P. Estimated GFR, albuminuria, and complications of chronic kidney disease. J Am Soc Nephrol. 2011 Dec;22(12):2322-31. doi: 10.1681/ASN.2010111181. Epub 2011 Sep 30.
Shah SV, Baliga R, Rajapurkar M, Fonseca VA. Oxidants in chronic kidney disease. J Am Soc Nephrol. 2007 Jan;18(1):16-28. doi: 10.1681/ASN.2006050500. Epub 2006 Dec 13.
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
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.
Other Identifiers
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USP Brazil
Identifier Type: OTHER
Identifier Source: secondary_id
54326916.4.0000.0068
Identifier Type: -
Identifier Source: org_study_id
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