CKD, Endothelial Dysfunction, Hemodialysis, Inflammation
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDried garlic powder (Garlic extract) - Allium sativum.
A tablet containing 300 mg dried garlic powder
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endocan | 12 weeks | To evaluate the impact of Garlic on endothelial dysfunction in chronic hemodialysis patients via assessment of Endocan. |
| interleukin-6 | 12 weeks | To evaluate the impact of Garlic on inflammation in chronic hemodialysis patients via assessment of IL-6 marker. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of garlic in CHD patients | 12 weeks | To evaluate the safety of Garlic in patients on HD by monitoring any adverse effects that may occur. |
| (KDQOL™-36) questionnaire | 12 weeks | To evaluate the impact of Garlic on quality of life in CHD patients |
Countries
Egypt
Outcome results
None listed