HemodialysisNCT07461012
Impact of Garlic on the Clinical Outcome in Chronic Hemodialysis Patients
A study testing Dried garlic powder (Garlic extract) - Allium sativum. in people with Hemodialysis and Endothelial Dysfunction, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Endothelial Dysfunction, CKD
- What is being tested?
- Dried garlic powder (Garlic extract) - Allium sativum.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Dried garlic powder (Garlic extract) - Allium sativum.
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried garlic powder (Garlic extract) - Allium sativum.Dietary supplement
A tablet containing 300 mg dried garlic powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
endocan
To evaluate the impact of Garlic on endothelial dysfunction in chronic hemodialysis patients via assessment of Endocan.
Measured: 12 weeks
interleukin-6
To evaluate the impact of Garlic on inflammation in chronic hemodialysis patients via assessment of IL-6 marker.
Measured: 12 weeks
Secondary outcomes (2)
safety of garlic in CHD patients
To evaluate the safety of Garlic in patients on HD by monitoring any adverse effects that may occur.
Measured: 12 weeks
(KDQOL™-36) questionnaire
To evaluate the impact of Garlic on quality of life in CHD patients
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, martina ezzat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461012
- Sponsor's protocol ID
- RHDIRB2020110301 REC#408
- Status last verified
- Sep 2025
- First submitted
- 5 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Garlic on the Clinical Outcome in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07461012
- Acronym / sponsor ID
- RHDIRB2020110301 REC#408
- Conditions
- Hemodialysis, Endothelial Dysfunction, CKD, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Garlic Group) | Experimental | Dietary Supplement: Dried garlic powder (Garlic extract) - Allium sativum.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried garlic powder (Garlic extract) - Allium sativum.A tablet containing 300 mg dried garlic powder | Dietary supplement | Group A (Garlic Group) |
Primary outcome
endocan
Time frame: 12 weeks
To evaluate the impact of Garlic on endothelial dysfunction in chronic hemodialysis patients via assessment of Endocan.
interleukin-6
Time frame: 12 weeks
To evaluate the impact of Garlic on inflammation in chronic hemodialysis patients via assessment of IL-6 marker.
2 secondary outcomes
safety of garlic in CHD patients
Time frame: 12 weeks
(KDQOL™-36) questionnaire
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dried garlic powder (Garlic extract) - Allium sativum. in people with Hemodialysis and Endothelial Dysfunction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endocan (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.