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Trial record 3 of 108 for:    Turmeric extract | Turmeric

Role of Turmeric on Oxidative Modulation in ESRD Patients

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. Identifier: NCT01906840
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Information provided by (Responsible Party):
Maryam Pakfetrat, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure Drug: Turmeric Drug: placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate the Effects of Turmeric on Oxidative Stress Markers in HD Patients
Study Start Date : April 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: drug: turmeric capsule
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
Drug: Turmeric
Placebo Comparator: Drug: placebo,capsule
Intervention is daily starch capsules 500 mg for 8 weeks
Drug: placebo

Primary Outcome Measures :
  1. effects of turmeric on oxidative stress markers [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

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Responsible Party: Maryam Pakfetrat, associated professor of shiraz Shiraz University of Medical Sciences, Shiraz University of Medical Sciences Identifier: NCT01906840     History of Changes
Other Study ID Numbers: Interventional
2483 ( Other Identifier: snurc )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013
Keywords provided by Maryam Pakfetrat, Shiraz University of Medical Sciences:
Chronic renal failure
Oxidative stress
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Turmeric extract
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs