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Role of Turmeric on Oxidative Modulation in ESRD Patients

Primary Purpose

End Stage Renal Failure

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Turmeric
placebo
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure focused on measuring Chronic renal failure, Hemodialysis, Oxidative stress, Turmeric

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • having the age of 18 years and more,
  • receiving 4-hour HD treatments 3 times per week at least for three months,
  • administering no other antioxidant medications

Exclusion Criteria:

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    drug: turmeric capsule

    Drug: placebo,capsule

    Arm Description

    Intervention is turmeric (one capsule with each meal containing 500 mg turmeric, of which 22.1 mg was the active ingredient curcumin; three capsules daily) for 8 weeks

    Intervention is daily starch capsules 500 mg for 8 weeks

    Outcomes

    Primary Outcome Measures

    effects of turmeric on oxidative stress markers

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2013
    Last Updated
    July 23, 2013
    Sponsor
    Shiraz University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01906840
    Brief Title
    Role of Turmeric on Oxidative Modulation in ESRD Patients
    Official Title
    Evaluate the Effects of Turmeric on Oxidative Stress Markers in HD Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shiraz University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Despite advances in prevention of cardiovascular diseases, the incidence of accelerated atherosclerosis in hemodialysis (HD) patients has still remained high. Oxidative stress is considered as a major player in uremia associated morbidity and mortality in HD patients. The aim of this study was to evaluate the effects of turmeric on oxidative stress markers in HD patients.
    Detailed Description
    End-stage renal disease (ESRD) is a state of oxidative stress, due to uremic oxidant mediator's accumulation, the activation of phagocytic oxidative metabolism by the dialysis membrane, intravenous iron therapy and the antioxidant depletion caused by hemodialysis (HD). Some trials showed a significant benefit from antioxidant therapy on cardiovascular outcome in HD patients. Extensive research focused on direct exogenous antioxidants including vitamin C, and vitamin E, in the treatment of cardiovascular disease. Some clinical trials showed no more beneficial effect of exogenous antioxidant supplementation in cardiovascular disease (CVD) and recommended the necessity for a new approach to regulating cellular redox status. Turmeric (Curcuma longa Linn) is an herb used as a dietary spice and in traditional medicine for centuries. Curcumin, the most active and non-toxic component of turmeric, is a polyphenol, which has been extensively studied for its therapeutic benefits, such as antioxidant. Besides, turmeric has also been effective in attenuation of proteinurea in diabetic nephropathy and lupus nephritis patients. Curcumin restored the activities of mitochondrial enzymes complexes and thereby attenuated the release of reactive oxygen species. Turmeric appears to be non-toxic to humans even at high doses. However, there is a paucity of information on the effect of turmeric in HD population. We have, therefore, followed up this study to determine the beneficial effect of turmeric on oxidative stress in HD patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Failure
    Keywords
    Chronic renal failure, Hemodialysis, Oxidative stress, Turmeric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    drug: turmeric capsule
    Arm Type
    Experimental
    Arm Description
    Intervention is turmeric (one capsule with each meal containing 500 mg turmeric, of which 22.1 mg was the active ingredient curcumin; three capsules daily) for 8 weeks
    Arm Title
    Drug: placebo,capsule
    Arm Type
    Placebo Comparator
    Arm Description
    Intervention is daily starch capsules 500 mg for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Turmeric
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    effects of turmeric on oxidative stress markers
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: having the age of 18 years and more, receiving 4-hour HD treatments 3 times per week at least for three months, administering no other antioxidant medications Exclusion Criteria:

    12. IPD Sharing Statement

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    Role of Turmeric on Oxidative Modulation in ESRD Patients

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