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Trial record 27 of 7867 for:    "Kidney Diseases"

Propolis Effects in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02766036
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Marcelo Augusto Duarte Silveira, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Drug: Propolis Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Propolis Effects on Proteinuria and Kidney Function in Patients With Chronic Kidney Disease
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: 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.
Drug: Propolis
Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses

Placebo Comparator: 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.
Drug: Placebo
Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses




Primary Outcome Measures :
  1. Reducing Proteinuria [ Time Frame: One year ]
    Reduction from baseline proteinuria.


Secondary Outcome Measures :
  1. Protection of the glomerular filtration rate [ Time Frame: One year ]
    Maintaining glomerular filtration rate or inferior reduction to 5 ml per minute per 1.73 m2 of body-surface area from baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766036


Locations
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Brazil
University of Sao Paulo General Hospital
Sao Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Chair: General Hospital University of Sao Paulo

Publications of Results:
Other Publications:
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Responsible Party: Marcelo Augusto Duarte Silveira, Principal Investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02766036     History of Changes
Other Study ID Numbers: 54326916.4.0000.0068
USP Brazil ( Other Identifier: University of São Paulo School of Medicine )
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Time Frame: The results of this research will be published to become public domain.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcelo Augusto Duarte Silveira, University of Sao Paulo General Hospital:
Proteinuria
Propolis
Chronic Kidney Disease

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Propolis
Anti-Infective Agents