Impact of Garlic on the Clinical Outcome in Chronic Hemodialysis Patients

Ain Shams University

Status: Completed

Conditions: Inflammation; Hemodialysis; Endothelial Dysfunction; CKD

Treatments: Dietary Supplement: Dried garlic powder (Garlic extract) - Allium sativum.

Study type: Interventional

Funder types: Other

Identifiers

NCT07461012

RHDIRB2020110301 REC#408

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Group A (Garlic Group)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dried garlic powder (Garlic extract) - Allium sativum.

Group B (control Group)

No Intervention group

Description:

It consists of 29 patients who will receive the standard treatment.