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Effect of Garlic Tablet Some Indicators Related to Atherosclerosis

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Garlic
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring CAD, CIMT, FMD

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • angiography confirmed coronary artery disease
  • lack of consistent use of the garlic in the last month

Exclusion Criteria:

Change in type of medication during study

Sites / Locations

  • Rajaei Cardiovascular, Medical & Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Garlic

Placebo

Arm Description

daily consumption of two odor controlled garlic tablets

daily consumption of placebo

Outcomes

Primary Outcome Measures

Carotid Intima Media Thickness
Change from baseline and compared to placebo group in Carotid Intima Media Thickness at 12 weeks

Secondary Outcome Measures

Flow-mediated dilatation
Change from baseline and compared to placebo group in Flow-mediated dilatation at 12 weeks

Full Information

First Posted
September 14, 2013
Last Updated
May 27, 2015
Sponsor
Shahid Beheshti University
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1. Study Identification

Unique Protocol Identification Number
NCT01948453
Brief Title
Effect of Garlic Tablet Some Indicators Related to Atherosclerosis
Official Title
Effect of Garlic Tablet on Carotid Intima Media Thickness and Flow-mediated Dilation in Patients Undergoing Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, CIMT, FMD

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Garlic
Arm Type
Active Comparator
Arm Description
daily consumption of two odor controlled garlic tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
daily consumption of placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Garlic
Intervention Description
Garlic tablet in adjunct to medical treatment
Primary Outcome Measure Information:
Title
Carotid Intima Media Thickness
Description
Change from baseline and compared to placebo group in Carotid Intima Media Thickness at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Flow-mediated dilatation
Description
Change from baseline and compared to placebo group in Flow-mediated dilatation at 12 weeks
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
plasma levels of Alanine Aminotransferase, Aspartate Aminotransferase, creatinine, lipid profile, C-Reactive Protein
Description
Change from baseline in plasma levels at 12 weeks
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: angiography confirmed coronary artery disease lack of consistent use of the garlic in the last month Exclusion Criteria: Change in type of medication during study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javad Nasrollahzadeh, Ph.D.
Organizational Affiliation
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
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Z Mehr, M.D.
Organizational Affiliation
Department of Cardiology, Rajaei Cardiovascular, Medical & Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marjan M Roshan, Ph.D.
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajaei Cardiovascular, Medical & Research Center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Garlic Tablet Some Indicators Related to Atherosclerosis

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