Effect of Garlic Tablet Some Indicators Related to Atherosclerosis
Effect of Garlic Tablet on Carotid Intima Media Thickness and Flow-mediated Dilation in Patients Undergoing Angioplasty
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this study is to determine whether garlic in adjunct to conventional medical treatment is effective in improving carotid intima media thickness (CIMT), Flow mediated dilation (FMD) and plasma lipid profile or c-reactive protein of coronary artery disease (CAD) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Aug 2013
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
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
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 14, 2013
CompletedFirst Posted
Study publicly available on registry
September 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 28, 2015
September 1, 2013
1.1 years
September 14, 2013
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Carotid Intima Media Thickness
Change from baseline and compared to placebo group in Carotid Intima Media Thickness at 12 weeks
12 weeks
Secondary Outcomes (1)
Flow-mediated dilatation
12 weeks
Other Outcomes (1)
plasma levels of Alanine Aminotransferase, Aspartate Aminotransferase, creatinine, lipid profile, C-Reactive Protein
12 weeks
Study Arms (2)
Garlic
ACTIVE COMPARATORdaily consumption of two odor controlled garlic tablets
Placebo
PLACEBO COMPARATORdaily consumption of placebo
Interventions
Eligibility Criteria
You may qualify if:
- angiography confirmed coronary artery disease
- lack of consistent use of the garlic in the last month
You may not qualify if:
- Change in type of medication during study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rajaei Cardiovascular, Medical & Research Center
Tehran, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Javad Nasrollahzadeh, Ph.D.
Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
- STUDY DIRECTOR
Ali Z Mehr, M.D.
Department of Cardiology, Rajaei Cardiovascular, Medical & Research Center
- PRINCIPAL INVESTIGATOR
Marjan M Roshan, Ph.D.
Department of Clinical Nutrition and Diet Therapy, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
September 14, 2013
First Posted
September 23, 2013
Study Start
August 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 28, 2015
Record last verified: 2013-09