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临床试验/NCT03214692
NCT03214692Unknown不适用

Potential Role of Gum Arabic as Antioxidant and Anti-inflammatory Agent in Hemodialysis Patients

Lamis Kaddam2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Change from baseline Tumor necrosis factor alpha

研究概览

简要总结

Oxidative processes increased in patients with renal failure and especially patients with end stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is claimed to have antioxidant effect and this will decrease the harmful effect of the free radical on patient on hemodialysis. In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.

详细描述

The oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.

Cells continuously produce free radicals and reactive oxygen species (ROS) as part of metabolic processes. These free radicals are neutralized by an elaborate antioxidant defense system consisting of enzymes such as catalase, superoxide dismutase, glutathione peroxidase, and numerous non-enzymatic antioxidants, including vitamins A, E and C and glutathione.

Oxidative stress has been linked to the pathogenesis of a variety of diseases, such as renal disease, cardiovascular disease, atherosclerosis, hypertension, cancer, diabetes, arthritis neurodegenerative diseases (i.e., Alzheimer's and Parkinson's disease), and aging.

The prevalence and incidence of patient suffering from chronic renal failure is increasing worldwide and locally in Sudan(5). Several publication suggest that oxidative processes may be increased in patients with renal failure. As oxidative stress plays a role in renal damage it offers a potential target for therapeutic intervention.

There is a lot of factors that can lead to oxidative stress in patients with chronic kidney disease (CKD) . Intravenous administration of iron is widely prescribed in patients with chronic kidney disease (CKD) and can cause oxidative stress.Hemodialysis is often used for removal of excessive toxins, metabolic products, and blood components from patients with end-stage renal diseases (ESRD). Clinical studies have confirmed that hemodialysis (HD) is associated with the development of oxidative stress and disturbance in the enzyme systems that protect against oxygen free radicals.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End stage renal disease patients on regular hemodialysis.

排除标准

  • Patient known have ischemic heart disease (coronary artery disease),
  • Pregnant women,
  • Patient who have impaired liver function or hepatitis VIRUS positive,
  • Patient who HIV positive and patient currently use of GUM Arabic.

研究组 & 干预措施

Gum Arabic

Experimental

The patients will receive 30 grams of Gum Arabic dissolved in 200 ml of water to ingest orally

干预措施: Gum Arabic (Dietary Supplement)

结局指标

主要结局

Change from baseline Tumor necrosis factor alpha

时间窗: Baseline and after 12 weeks

pg/mL

Change from baseline Oxidative stress marker malondialdehyde

时间窗: Baseline and after 12 weeks

nmol/mL

次要结局

  • Glomerular Filtration Rate (GFR)(Baseline and every four weeks for 12 weeks)

研究者

发起方
Lamis Kaddam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lamis Kaddam

Dr

Al-Neelain University

研究点 (2)

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