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Effect of Aged Garlic Extract on Atherosclerosis (Garlic4)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01534910
First Posted: February 17, 2012
Last Update Posted: April 20, 2017
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.
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
Results First Submitted: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Metabolic Syndrome
Interventions: Drug: aged garlic extract
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
all 65 participants were recruited

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sugar Pill

placebo

placebo: placebo

Aged Garlic Extract

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day


Participant Flow:   Overall Study
    Sugar Pill   Aged Garlic Extract
STARTED   33   32 
COMPLETED   29   28 
NOT COMPLETED   4   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill

placebo

placebo: placebo patients were randomized to placebo

Aged Garlic Extract

2400 mg of aged garlic extract

aged garlic extract: 2400 mg a day patients randomized to aged garlic extract

Total Total of all reporting groups

Baseline Measures
   Sugar Pill   Aged Garlic Extract   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   32   65 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      33 100.0%      32 100.0%      65 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (7)   56  (8)   57  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  27.3%      8  25.0%      17  26.2% 
Male      24  72.7%      24  75.0%      48  73.8% 
Region of Enrollment 
[Units: Participants]
     
United States   33   32   65 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   CT Angiography Plaque   [ Time Frame: baseline to 1 year ]

2.  Secondary:   Coronary Calcium   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Matthew Budoff
Organization: Los Angeles Biomedical Research Institute
phone: 310-222-4107
e-mail: mbudoff@labiomed.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT01534910     History of Changes
Other Study ID Numbers: 21567-01
First Submitted: February 14, 2012
First Posted: February 17, 2012
Results First Submitted: February 20, 2015
Results First Posted: April 3, 2015
Last Update Posted: April 20, 2017