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the effect of garlic supplementation therapy on the rate of atherosclerosis change in coronary arteries in ischemic heart disease patients

Protocol summary

Study aim
The effect of garlic supplementation on changes in coronary atherosclerosis in cardiac ischemia patients
Design
Patients in both groups were blind in terms of the type of intervention given the similar form of medication and the physician would not be aware of the type of treatment. Medication information will be tracked and coded. Blinding or blinding will be done by the researcher and medications will be given by the nurse in charge of the patient's delivery department.
Settings and conduct
patients referring to cardiology and angiography ward of Kashan Shahid Beheshti Hospital and will be enrolled in the study as an informed consent trial. Individuals will be divided into two groups according to the randomization block method.
Participants/Inclusion and exclusion criteria
All patients with coronary artery stenosis will be enrolled after angiography with stenosis greater than or equal to 60% in at least two veins. These included patients admitted to MI and ACS and patients with stable angina who were candidates for angiography and, according to the observation physician, were candidates for two or more angioplasty in two sessions. The percentage of stenosis in the vessels involved is initially determined and in the first session of one of the vessels angioplasty is performed and before the second angioplasty the patients are randomly divided into control and intervention groups
Intervention groups
In a group of 8 weeks between two angiograms in addition to standard drug administration (statin, ASA, clopidogrel, hypertension medication) by a physician, 2 garlic pills daily will given to patients containing 300 mg of dried garlic powder from the company of Gul Darou.
Main outcome variables
Blood tests for CBC, TG, Chol, LDL, HDL, FBS, Hba1c, CRP, Cr and blood pressure and then for angioplasty will also be recorded by QCA angiography for coronary stenosis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191113045431N1
Registration date: 2020-01-17, 1398/10/27
Registration timing: prospective

Last update: 2020-01-17, 1398/10/27
Update count: 0
Registration date
2020-01-17, 1398/10/27
Registrant information
Name
sajjad zarrati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0139
Email address
sajjad.zarrati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-05-01, 1399/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of garlic supplementation therapy on the rate of atherosclerosis change in coronary arteries in ischemic heart disease patients
Public title
the effect of garlic on the rate of atherosclerosis change in coronary arteries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who have two or more obstraction in coronary arteries Patient who have only one PCI on coronery artery in one operation Patient who is reliable to fallow his medication
Exclusion criteria:
Patient who are hypersensetive to galic
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
block randomized manner using the random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo and medicines are packaged and coded. The caregiver delivers them to the patients without knowing the contents of the package. Patients also dont know the content pf packages. Information is also collected without knowing the contents of the packages.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Street address
ghotb ravandi Blvd, pezeshk Blvd, kashan university of medical science
City
kashan
Province
Isfehan
Postal code
8715973474
Approval date
2018-08-13, 1397/05/22
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.036

Health conditions studied

1

Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.10
ICD-10 code description
Atherosclerotic heart disease of native coronary artery without angina pectoris

Primary outcomes

1

Description
Percentage of coronary artery stenosis
Timepoint
Measurement on two occasions of angioplasty for at least 8 weeks
Method of measurement
Measurement of QCA by angiography device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In 8 weeks between two angiograms in addition to standard drug (statin, ASA, clopidogrel, hypertension medication) ,administration by a physician, 2 garlic pills daily containing 300 mg of dried garlic powder from the company of Gul Darou and two grams of garlic equivalent, Will be given
Category
Treatment - Drugs

2

Description
Control group: Patients who did not receive garlic tablets between two angiography sessions
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Dr Hasan Rajabimoghadam
Street address
Ghotb ravandi Blvd, Pezeshk Blvd, Shahid Beheshti Hospital
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0026
Email
info@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Banafshe
Street address
Ghotbravandi Blvd, Pezeshk Blvd, Kashan University Of Medical Science
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sajjad Zarrati
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Sotude Blvd
City
Kashan
Province
Isfehan
Postal code
8714849311
Phone
+98 31 5554 0139
Email
sajjad.zarrati@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sajjad Zarrati
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Sotude Blvd
City
Kashan
Province
Isfehan
Postal code
8714843911
Phone
+98 31 5554 0139
Email
sajjad.zarrati@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Sajjad Zarrati
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Sotude Blvd
City
kashan
Province
Isfehan
Postal code
8714843911
Phone
+98 31 5554 0139
Email
sajjad.zarrati@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the main outcome data
When the data will become available and for how long
Start access period concurrently with release
To whom data/document is available
Everyone
Under which criteria data/document could be used
No special conditions
From where data/document is obtainable
Send responsible email
What processes are involved for a request to access data/document
Request via email and then send it after viewing the email
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