Back to resultsEffect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Primary Purpose
Proteinuria
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Curcumin
Sponsored by
About this trial
This is an interventional treatment trial for Proteinuria
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection.
- Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination.
Exclusion Criteria:
- Hepatic damage.
- Malignancy.
- Pregnancy.
- Peritoneal or hemodialysis.
- Organ transplantation.
- Heart failure classification III or IV (New York Heart Association).
- History of chemotherapy within 2 years prior to screening.
Sites / Locations
- Instituto Nacional de Cardiologia Ignacio Chavez
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Diabetic
Non-diabetic
Arm Description
Outcomes
Primary Outcome Measures
Change in proteinuria
Secondary Outcome Measures
Full Information
NCT ID
NCT01831193
First Posted
April 9, 2013
Last Updated
July 23, 2014
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
1. Study Identification
Unique Protocol Identification Number
NCT01831193
Brief Title
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Official Title
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria in patients with chronic kidney disease regardless the ethiology.
Detailed Description
Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa L.
Different studies have demonstrated that curcumin has potent biological activity and therefore is an effective therapeutic agent for the treatment of various ailments.
This compound acts as a bifunctional antioxidant:
ه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by its ability to induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway.
Although RAAS blockade is the cornerstone to prevent the progression of proteinuric nephropathy, a significant number of patients remained with proteinuria and progress to end-stage renal disease.
Due to the low cost and few side effects of curcumin, this could become an adjuvant treatment of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetic
Arm Type
Active Comparator
Arm Title
Non-diabetic
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Curcumin
Other Intervention Name(s)
Turmeric
Primary Outcome Measure Information:
Title
Change in proteinuria
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection.
Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination.
Exclusion Criteria:
Hepatic damage.
Malignancy.
Pregnancy.
Peritoneal or hemodialysis.
Organ transplantation.
Heart failure classification III or IV (New York Heart Association).
History of chemotherapy within 2 years prior to screening.
Facility Information:
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez
City
Mexico city
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
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