NCT01948453

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

September 14, 2013

Last Update Submit

May 27, 2015

Conditions

Keywords

CADCIMTFMD

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 COMPARATOR

daily consumption of two odor controlled garlic tablets

Dietary Supplement: Garlic

Placebo

PLACEBO COMPARATOR

daily consumption of placebo

Interventions

GarlicDIETARY_SUPPLEMENT

Garlic tablet in adjunct to medical treatment

Garlic

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • 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 CHAIR
  • Ali Z Mehr, M.D.

    Department of Cardiology, Rajaei Cardiovascular, Medical & Research Center

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

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

Locations