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
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
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
NCT ID
NCT01906840
First Posted
July 21, 2013
Last Updated
July 23, 2013
Sponsor
Shiraz University of Medical Sciences
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
Learn more about this trial
Role of Turmeric on Oxidative Modulation in ESRD Patients
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