Impact of Garlic on the Clinical Outcome in Chronic Hemodialysis Patients

NCT07461012 | Completed

• 1 other identifier: RHDIRB2020110301 REC#408
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Endothelial Dysfunction; CKD; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• safety of garlic in CHD patients

  12 weeks

• (KDQOL™-36) questionnaire

  12 weeks

Study Arms (2)

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.

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

Group B (control Group)

NO INTERVENTION

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

Interventions

Dried garlic powder (Garlic extract) - Allium sativum. DIETARY_SUPPLEMENT

A tablet containing 300 mg dried garlic powder

Group A (Garlic Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of pharmacy Ain Shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at faculty of pharmacy Ain Shams university

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2026

Record last verified: 2025-09

Locations

EG (1)