Role of Turmeric on Oxidative Modulation in ESRD Patients

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01906840
Study type	Interventional
Source	Shiraz University of Medical Sciences
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2011
Completion date	August 2012

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.