This study will be conducted in the heart department of Afshar Hospital. The patients will be divided into two groups receiving garlic tablets and placebo using a random permutation block method. Nurses will be given and participants, researchers, physicians and data collectors will be unaware of this list.
Participants/Inclusion and exclusion criteria
Age 18 years and above - Patient hospitalized in Afshar Hospital under coronary angio-antiviral - No nephrotoxic drugs - No drug containing garlic in the past one month - No garlic - Toleration of oral drugs - Hospitalization in cardiac special care for two days - The consent of the patient or his legal guardian.
Intervention groups
In this study, 70 non-emergency patients who undergo coronary angioplasty and meet the inclusion criteria, after explaining the objectives of the study and obtaining written and informed consent, were randomly selected in two groups of 35 people by available sampling method. They are treated and controlled. The pills of both groups (garlic and placebo) are similar in appearance, and the research student and the patient are not aware of the drug content. Patients are selected in a random permutation block to receive placebo or Garcin 500 mg one dozen days before surgery. The garlic tablet used is from Gol Daru company under the brand name Garcin, each tablet contains 500 mg of dried powder.
Main outcome variables
Nephropathy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190911044744N5
Registration date:2024-03-07, 1402/12/17
Registration timing:registered_while_recruiting
Last update:2024-03-07, 1402/12/17
Update count:0
Registration date
2024-03-07, 1402/12/17
Registrant information
Name
Ehsan Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 1820 5885
Email address
ehsan.mirzaei.1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of garlic in the prevention of contrast induced nephropathy in following coronary angiography
Public title
Investigating the effectiveness of garlic in the prevantion of nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above
Patient hospitalized in Afshar Hospital undergoing coronary artery angioplasty
Not receiving nephrotoxic drugs
Not taking garlic-containing drugs in the past one month
No history of allergy to garlic
Tolerating the use of oral drugs
Hospitalization in the special heart care unit for 2 days
Informed consent of the patient or his legal guardian
Exclusion criteria:
Pregnant or lactating mother
Allergy to garlic
Anticoagulant medication in the last 2 week
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method:
Patients are divided into 2 groups of 35 people and using statistical software, 35 patients out of 70 patients are completely randomly placed in the treatment group and 35 patients in the placebo group.
Randomization unit: individual
Randomization tool: statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the main researcher, the doctors, and the person in charge of data collection will be kept blind, so that the list of people who are going to receive medicine or placebo will be provided to the head of the heart department with a number.
Feedback
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Shahid Sadougi University of Medical Sciences, Yazd
Street address
Faculty of pharmacy, Yazd, Shohada gomnam St.,Alam square
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.130
Health conditions studied
1
Description of health condition studied
Prevention of nephropathy
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Nephropathy rate
Timepoint
48 hours after the operation
Method of measurement
Examining serum creatinine levels in patient tests
Secondary outcomes
1
Description
Serum creatinine levels
Timepoint
48 hours after operation
Method of measurement
Examining serum creatinine levels in patient tests
Intervention groups
1
Description
Intervention group: recipients of 500 mg garlic tablets from Gol Daru company, took one tablet orally 12 hours before angiography to reduce nephrotoxicity of the contrast material and control renal parameters.
Category
Treatment - Drugs
2
Description
Control group: recipients of a placebo prepared in the pharmacy laboratory of Yazd Faculty of Pharmacy in the same size and color as Garcin tablets,12 hours before coronary angiography, receive the tablet orally to reduce the nephrotoxicity of contrast material and control renal parameters.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Ehsan Mirzaei
Street address
Yazd, Jomhory blvd, Afshar Hospital
City
Yazd
Province
Yazd
Postal code
8917945556
Phone
+98 35 2535 5011
Email
ehsan.mirzaei.1369@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Hosein Zare- Dr.Mohsen Zabihi
Street address
Faculty of pharmacy,Yazd, Shohada gomnam St, Alam aquare
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 2038 1934
Email
Ho3inzare2476@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
1
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
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Yazd, Shohada gomnam St, Alam square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 2038 1934
Email
Ehsan.mirzaei.1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Yazd, Shohada gomnam St, Alam square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3419 3820
Email
Ehsan.mirzaei.1369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Hosein Zare
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Yazd, Shohada gomnam St, Alam square
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3419 3820
Email
Ehsan.mirzaei.1369@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available