Effect of Garlic Tablet Some Indicators Related to Atherosclerosis

May 27, 2015 updated by: Javad Nasrollahzadeh, Shahid Beheshti University

Effect of Garlic Tablet on Carotid Intima Media Thickness and Flow-mediated Dilation in Patients Undergoing Angioplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Garlic
daily consumption of two odor controlled garlic tablets
Dietary supplement: Garlic
Garlic tablet in adjunct to medical treatment
Placebo Comparator: Placebo
daily consumption of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carotid Intima Media Thickness
Time Frame: 12 weeks
Change from baseline and compared to placebo group in Carotid Intima Media Thickness at 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow-mediated dilatation
Time Frame: 12 weeks
Change from baseline and compared to placebo group in Flow-mediated dilatation at 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma levels of Alanine Aminotransferase, Aspartate Aminotransferase, creatinine, lipid profile, C-Reactive Protein
Time Frame: 12 weeks
Change from baseline in plasma levels at 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 14, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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