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The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients (POMX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00470808
Recruitment Status : Unknown
Verified April 2007 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2007
Last Update Posted : May 8, 2007
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE May 7, 2007
First Posted Date  ICMJE May 8, 2007
Last Update Posted Date May 8, 2007
Study Start Date  ICMJE May 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atherosclerosis
Intervention  ICMJE Drug: POMx
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE August 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males
  • HBA1C>7%
  • Drug therapy given for DM

Exclusion Criteria:

  • Age<18
  • Inclusion in another study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00470808
Other Study ID Numbers  ICMJE 0051-07-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wasseem Rock, MD Ha'Emek Medical Center
PRS Account HaEmek Medical Center, Israel
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP