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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Garlic Group) | Experimental | 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. |
|
| Group B (control Group) | No Intervention | It consists of 29 patients who will receive the standard treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dried garlic powder (Garlic extract) - Allium sativum. | Dietary Supplement | A tablet containing 300 mg dried garlic powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| endocan | To evaluate the impact of Garlic on endothelial dysfunction in chronic hemodialysis patients via assessment of Endocan. | 12 weeks |
| interleukin-6 | To evaluate the impact of Garlic on inflammation in chronic hemodialysis patients via assessment of IL-6 marker. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety of garlic in CHD patients | To evaluate the safety of Garlic in patients on HD by monitoring any adverse effects that may occur. | 12 weeks |
| (KDQOLâ„¢-36) questionnaire | To evaluate the impact of Garlic on quality of life in CHD patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of pharmacy Ain Shams university | Cairo | Egypt |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 12 weeks |