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| Tracking Information | |||||
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| First Received Date ICMJE | May 7, 2007 | ||||
| Last Updated Date | May 7, 2007 | ||||
| Start Date ICMJE | May 2007 | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients | ||||
| Official Title ICMJE | |||||
| Brief Summary | Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Atherosclerosis | ||||
| Intervention ICMJE | Drug: POMx | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Enrollment ICMJE | |||||
| Estimated Completion Date | August 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Expanded Access Status | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00470808 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 0051-07-EMC | ||||
| Study Sponsor ICMJE | HaEmek Medical Center, Israel | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | HaEmek Medical Center, Israel | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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