Diabetes MellitusNCT00428532
The Effect of Licorice Root Extract and Pomegranate Juice on Atherosclerotic Parameters in Diabetic Patients
A study testing Licorice root extract or Pomegranate juice in people with Diabetes Mellitus and Atherosclerosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Atherosclerosis
- What is being tested?
- Licorice root extract or Pomegranate juice
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- Diabetes Mellitus
Who cannot join
- Younger than 18
- Smoker
- Receiving Fibrates
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
HaEmek MC
Afula
Wasseem Rock, MD, 0547-866896, wasseem_rock@yahoo.com
Wasseem Rock, MD
About this study
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.
- Conditions
- Diabetes Mellitus, Atherosclerosis
- Being tested
- Licorice root extract or Pomegranate juice
- Medical subject headings
- Diabetes Mellitus, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licorice root extract or Pomegranate juiceDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startMar 2007
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Wasseem Rock, MD, Principal investigator, Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428532
- Sponsor's protocol ID
- 009-07-EMC
- Status last verified
- Jan 2007
- First submitted
- 27 Jan 2007
- Last updated
- 8 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Licorice Root Extract and Pomegranate Juice on Atherosclerotic Parameters in Diabetic Patients
- ClinicalTrials.gov ID
- NCT00428532
- Acronym / sponsor ID
- 009-07-EMC
- Conditions
- Diabetes Mellitus, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Aug 2007 (estimated)
- First posted
- 30 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male
- Diabetes Mellitus
Key exclusion criteria (3 listed)
- Younger than 18
- Smoker
- Receiving Fibrates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Licorice root extract or Pomegranate juice | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasseem Rock, MD principal investigator
Ha'Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Licorice root extract or Pomegranate juice in people with Diabetes Mellitus and Atherosclerosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wasseem Rock, MD (972-547866896, wasseem_rock@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2007.