The Prophylactic Effect of Garlic Tablets to Prevent Nosocomial Infections in Intensive Care Unit Patients.

October 2, 2025 updated by: Alexandria University

The goal of this clinical trial is to learn if garlic tablets works to prevent nosocomial infections in hospitalized patients in ICU. The main questions it aims to answer are:

Does garlic tablets administration lower the occurence of nosocomial infections in hospitalized patients in ICU?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Alexandria Governorate
      • Alexandria, Alexandria Governorate, Egypt, 21563
        • Alexandria main university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients aged from 18 to 65 years old admitted to intensive care units without any type of infection.

Exclusion Criteria:

  1. Patients with signs /symptoms of infection.
  2. Patients with human immunodeficiency virus, malignancy and patients with a history of recent immunosuppressants or corticosteroids administration.
  3. Patients with bleeding disorders or abnormal coagulation profile
  4. Patients who will planned for surgery within 2 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The intervention group
The patients in the intervention group which will receive garlic tablets (Tomex plus 300 mg) two tablets twice daily for 6 days just after ICU admission
Drug: Garlic powder standardized to allicin
The intervention is the administration of garlic tablets (Tomex plus 300 mg) two tablets twice daily (which contains 5.4 mg allicin the active ingredient with anibacterial effect) for 6 days just after ICU admission
No Intervention: The control group
The patients in the control group which will not receive the garlic tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of central line-associated bloodstream infections, catheter- associated urinary tract infections, surgical site infections and ventilator- associated pneumonia in the two groups (by cultures results).
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .
Time Frame: one year
The Mean of Blood white cell count (number per micro liter) , body temperature ( by the degree Celsius) and C-reactive protein (milligrams per liter ) of the patients in the two groups will be calculated.
one year
Values of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups .
Time Frame: one year
The Mean of Blood white cell count, body temperature and C-reactive protein of the patient in the two groups will be calculated.
one year

Other Outcome Measures

Outcome Measure
Time Frame
Antibiotics consumption as total number of vials per each antibiotic in the two groups.
Time Frame: one year
one year
Lenghth of stay of patients in ICU (by average number of days) in the two groups
Time Frame: one year
one year
Mortality rate of patients in the two groups
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 15, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0108752

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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