NCT00428532

Brief Summary

The study will check whether taking 100 mg of licorice root extract or 250 cc of pomegranate juice daily by men with diabetes mellitus who are non-smokers and already treated with statins decreases the risk of developing atherosclerosis. The hypothesis of the study is that natural anti-oxidants (such as licorice root extract and pomegranate juice), by scavenging free radicals, retard and may even reverse atherosclerosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2007

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 8, 2007

Status Verified

January 1, 2007

First QC Date

January 27, 2007

Last Update Submit

May 7, 2007

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Diabetes Mellitus

You may not qualify if:

  • Younger than 18
  • Smoker
  • Receiving Fibrates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek MC

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusAtherosclerosis

Interventions

Glycyrrhiza glabra extract

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wasseem Rock, MD

    Ha'Emek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2007

First Posted

January 30, 2007

Study Start

March 1, 2007

Study Completion

August 1, 2007

Last Updated

May 8, 2007

Record last verified: 2007-01

Locations