Impact of Garlic on the Clinical Outcome in Chronic Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Hemodialysis; CKD; Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: Dried garlic powder (Garlic extract) - Allium sativum.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • faculty of pharmacy Ain Shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Dried garlic powder (Garlic extract) - Allium sativum.; A tablet containing 300 mg dried garlic powder
No Intervention: Group B (control Group); It consists of 29 patients who will receive the standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
(KDQOL™-36) questionnaire	To evaluate the impact of Garlic on quality of life in CHD patients	12 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: RHDIRB2020110301 REC#408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No