Impact of Garlic on the Clinical Outcome in Chronic Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- endocan
研究概览
简要总结
Chronic kidney disease (CKD) is an irreversible condition marked by reduced kidney function or structural abnormalities lasting over three months, affecting a significant portion of the global population. It leads to a cycle of complications including albuminuria, anemia, mineral bone disorders, inflammation, oxidative stress, and accumulation of uremic toxins. These factors contribute to endothelial dysfunction (ED) and elevate the risk of cardiovascular diseases (CVDs), which are the primary cause of death in end stage kidney disease (ESKD) patients, especially those undergoing hemodialysis (HD). Hemodialysis further aggravates systemic inflammation and oxidative stress, increasing levels of cytokines like IL-6, TNF-α, and CRP. Endocan, a proteoglycan secreted by endothelial cells in response to inflammation, is a promising biomarker for ED and CVD risk, with levels that correlate with CKD severity. Garlic (Allium sativum) contains bioactive compounds with proven anti-inflammatory, antioxidant, and endothelial protective effects. This trial was suggested based on a study that has reported that giving 400 mg of garlic extract twice a day for 8 weeks in peritoneal dialysis patients resulted in significant reduction in IL-6, CRP and ESR. This study aims to investigate the effect of Garlic on Endothelial dysfunction and inflammation in chronic hemodialysis patients via assessment of Endocan as an endothelial dysfunction marker and IL-6 as an inflammation marker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged above 18 years with confirmed diagnosis of CKD.
- •Patients on HD for at least 3 months before enrollment.
- •Patients not participating in other clinical trials.
- •Physically stable.
排除标准
- •Patients diagnosed with digestive diseases as ileal bypass.
- •Patients with a history of hemorrhagic disorders or taking medications like warfarin.
- •Patients sensitive to garlic.
- •Patients with history of alcohol or drug abuse.
- •Patients receiving other anti-inflammatory medications (e.g. use of vitamin E at a dose higher than 60 IU per day or vitamin C higher than 500 mg per day)
研究组 & 干预措施
Group A (Garlic Group)
It consists of 29 patients who will receive a tablet containing 300 mg dried garlic powder three times daily for 12 weeks. (Tomex® plus, ATOS Pharma, Egypt) besides the standard treatment.
干预措施: Dried garlic powder (Garlic extract) - Allium sativum. (Dietary Supplement)
Group B (control Group)
It consists of 29 patients who will receive the standard treatment.
结局指标
主要结局
endocan
时间窗: 12 weeks
To evaluate the impact of Garlic on endothelial dysfunction in chronic hemodialysis patients via assessment of Endocan.
interleukin-6
时间窗: 12 weeks
To evaluate the impact of Garlic on inflammation in chronic hemodialysis patients via assessment of IL-6 marker.
次要结局
- safety of garlic in CHD patients(12 weeks)
- (KDQOL™-36) questionnaire(12 weeks)
研究者
martina ezzat
Teaching assistant at faculty of pharmacy Ain Shams university
Ain Shams University
