- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247039
Garlic in Patients With Febrile Neutropenia
A Controlled Study to Determine The Clinical Efficacy Of Garlic Compounds In Patients With Chemotherapy Related Febrile Neutropenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: moshe e gatt, dr
- Phone Number: 972-50-5172333
- Email: dr.mgatt@gmail.com
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
-
Contact:
- arik Tzukert, DMD
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
-
Principal Investigator:
- moshe e gatt, dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
FN patients expected to have at least 5 days or more of neutropenia will be eligible for treatment with garlic compounds AST/ALT ≤ 3 times the upper limit of institutional laboratory normal.
Total bilirubin ≤ 2 times the upper limit of institutional laboratory normal.
BUN and creatinine should be ≤ 3 times the upper limit of institutional laboratory normal.
Newly diagnosed as well as previously treated patients will be eligible.
Exclusion Criteria:
History of clinically significant liver or kidney disease.
Patients on anti-coagulation therapy with Coumadin will be excluded because of the potential garlic interference with metabolism.
Patients receiving concomitant chemotherapeutic treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Garlic extract
Garlic extract capsules
|
Dietary Supplement: garlic natural compound one pill, 450 mg active garlic extract (Solgar, Israel), bid.
|
Placebo Comparator: Placebo
Placebo capsules
|
placebo capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to fever and beginning of empiric antibiotic treatment.
Time Frame: 0-45 days post chemotherapy
|
0-45 days post chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Documented and culture positive infections.
Time Frame: as above
|
as above
|
Kind of infectious organisms and sensitivity to medicines.
Time Frame: as above
|
as above
|
Length of infection
Time Frame: as above
|
as above
|
Use of growth factors.
Time Frame: as above
|
as above
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: moshe e gatt, dr, Hadassah Medical Organization
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 384 gar 1- HMO-CTIL
- GAR1 (Other Grant/Funding Number: Dunsky grant for cancer research)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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