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Effect of Gundelia tournefortii extracts on Plasminogen Activator Inhibitor-1, Thromboxane B2, Lipid Profile, Antioxidant Capacity in Patients with Coronary Artery Disease

Protocol summary

Summary
This study is designed to determine the effect of Gundelia tournefortii extracts on Plasminogen Activator Inhibitor-1, Thromboxane B2, Lipid Profile, Antioxidant Capacity in Patients with Coronary Artery Disease. 45 eligible subjects with angiographically confirmed cardiovascular disease with more than 50% stenosis of at least one of the major coronary vessels will enter to the study.afterwards they will be divided randomly into two intervention and placebo groups. 23 participants in intervention group and 22 participants in placebo group will receive one 500 mg capsules,one time a day for 2 months. personality questionnaire, food frequency questionnaire, 3 days food records and physical activity questionnaire will be completed from study subjects. weight, height, waist, hip circumferences,blood pressure, PAI-1, Thromboxane B2, Lipid Profile and Antioxidant Capacity at baseline and the end of the study will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013102311288N6
Registration date: 2014-02-11, 1392/11/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of Gundelia tournefortii extracts on Plasminogen Activator Inhibitor-1, Thromboxane B2, Lipid Profile, Antioxidant Capacity in Patients with Coronary Artery Disease
Public title
Effect of Gundelia tournefortii on Coronary Heart Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:angiographically confirmed coronary artery disease with more than 50% stenosis of at least one of the major coronary vessels; subjects with 30-60 years old; BMI equal 20-30 kg/m2 exclusion criteria:Myocardial infarction, heart failure, heart valve disease, myocardial inflammation, stress and severe inflammation, smoking, more than 8 hours per week of vigorous exercise, diabetes, immunosuppressive drugs, anti-inflammatory and antioxidant vitamin supplements and herbal medicine, weight loss drugs or weight loss surgery.
Age
From 30 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Tabriz University of Medical Sciences
Street address
Vice – Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences,University Daneshgah Street, PO Box :51664,
City
Tabriz
Postal code
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
92173

Health conditions studied

1

Description of health condition studied
Coronary Heart Disease
ICD-10 code
I70-I79
ICD-10 code description
Atherosclerotic Heart Disease

Primary outcomes

1

Description
Antioxidant Capacity
Timepoint
Beginning and the end of the intervention
Method of measurement
Special kits

2

Description
Plasminogen Activator Inhibitor-1
Timepoint
Beginning and the end of the intervention
Method of measurement
Special kits

3

Description
Thromboxane B2
Timepoint
Beginning and the end of the intervention
Method of measurement
Special kits

4

Description
Lipid Profile
Timepoint
Beginning and the end of the intervention
Method of measurement
TC,TG,HDL-C,LDL-C mesearment with special kits

Secondary outcomes

1

Description
Blood Pressure
Timepoint
Beginning and the end of the intervention
Method of measurement
Standard Sphygmomanometer

Intervention groups

1

Description
Intervention group:Consumption of Gundelia tournefortii extracts equivalent 6 gr Gundelia tournefortii (500 mg capsules one time a day)
Category
Treatment - Drugs

2

Description
Placebo group: Consumption of starch(500 mg capsules one time a day)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed-al-shohada
Full name of responsible person
Mohammad Alizadeh
Street address
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Allahverdipour HamidReza
Street address
Dean Office, Faculty of Health and Nutrition,Tabriz University of Medical Sciences, Golgash St.
City
Tabriz
Grant name
بودجه دانشگاه
Grant code / Reference number
Not Applicable
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Position
Assistant Professor of Nutrition, Ph.D., M.D
Other areas of specialty/work
Street address
Department Of Nutrition, Faculty Of Nutrition, Gholghasht st.
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 7313
Fax
+98 41 1334 4731
Email
mdalizadeh@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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