Propolis Effects in Patients With Chronic Kidney Disease

NCT ID: NCT02766036

Last Updated: 2018-05-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Group Type ACTIVE_COMPARATOR

Propolis

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* older than 18 years;
* 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

* Pregnants;
* Neoplasia carrier;
* Renal transplant patients;
* Patients who refuse to participate in the study.
* Glomerulopathy on Immunosuppression
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marcelo Augusto Duarte Silveira

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Brazil

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.

Reference Type BACKGROUND
PMID: 10665935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26220625 (View on PubMed)

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.

Reference Type RESULT
PMID: 25607548 (View on PubMed)

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.

Reference Type RESULT
PMID: 23320022 (View on PubMed)

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.

Reference Type RESULT
PMID: 15660575 (View on PubMed)

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.

Reference Type RESULT
PMID: 21965377 (View on PubMed)

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.

Reference Type RESULT
PMID: 17167116 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37916745 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31023272 (View on PubMed)

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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