Determination of the efficacy of oral administration of Allium sativum on lipid profile, inflammatory and cardiovascular indexes in patients undergoing hemodialysis
Design
60 eligible patients undergoing hemodialysis; according to exclusion and inclusion criteria, were chosen purposefully and a code was allocated to each one of them. The patients were randomly divided into two group.
Settings and conduct
Study will be done in bolol rohani hospital dialysis center,according to balanced block randomization method,In intervention group,they received 400 mg of standard garlic powder extract tablets twice a day for 8 weeks,each tablet contains 1000 micrograms of allin.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age above 18;
Exclusion criteria:
Recent use of medicines and food containing garlic; history of garlic sensitivity; history of bleeding disorders; and the use of warfarin; history of ileal bypass; history of infection or admission during the past three months; unwillingness to participate in the research project and taking medication
Intervention groups
In intervention group, in addition to the standard treatment, patients received 400 mg of standard garlic powder extract tablets twice a day for 8 weeks. each tablet contains 1000 micrograms of alliin.
In the control group, a placebo was prescribed during this period.
Main outcome variables
Lipid profile, inflammatory and cardiovascular indicators, IL6, CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170725035305N2
Registration date:2018-01-21, 1396/11/01
Registration timing:registered_while_recruiting
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Amirhesam Alirezaei
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 3095
Email address
aalirezaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of oral administration of Allium sativum on lipid profile, inflammatory and cardiovascular indexes among hemodialysis patients
Public title
Efficacy of oral administration of Allium sativum on lipid profile, inflammatory and cardiovascular indexes among hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
6 month after initiation of hemodialysis
Exclusion criteria:
Recent use of medicines and foods that contain garlic
Sensitivity to garlic
History of bleeding
History of infection or hospitalization in the past 3 month
History of warfarin use
History of ileal bypass
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The qualified patients were divided into intervention and control groups (each group consisted of half the patients) according to balanced block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the investigator won't receive information on which type of treatment and which individual will receive the placebo or treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Bldg No.2 , hahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, chamran highway,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.548
Health conditions studied
1
Description of health condition studied
Renal Hemodyalisis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
Lipid profile
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement
2
Description
IL6
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement
3
Description
ESR
Timepoint
Before and after intervention
Method of measurement
Laboratory
4
Description
Homocysteine
Timepoint
Before and after intervention
Method of measurement
Laboratory measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients received 400 mg of standard garlic powder extract tablets twice aday for 8 weeks. each tablet contains 1000 micrograms of alliin. The drug was produced by the Amin pharmaceutical company.
Category
Treatment - Drugs
2
Description
Control group: The placebo was prescribed. The placebo was completely similar to the original drug and it was made of starch. Patients will receive placebo tablets twice a day for 8 weeks. The drug was produced by the Amin pharmaceutical company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatolah Rohani Hospital, Dialysis Center
Full name of responsible person
Amirhesam Alirezaei
Street address
Ayatolah Rohani Hospital, Ganjafruz Street, Babol, Mazandaran province
City
Babol
Province
Mazandaran
Postal code
Phone
+98 11 3219 6064
Email
Amirhesam124@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Moddares Hospital, Dialysis Center
Full name of responsible person
Amirhesam Alirezaei
Street address
Shahid Modarres Hospital, Saadat Abad Blvd., Yadegar Emam Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4092
Email
Amirhesam124@gmail.com
Web page address
http://modarres.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziaei
Street address
7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Velenjak, Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Email
Amirhesam124@gmail.com
Web page address
http://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirhesam Alirezaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Velenjak, Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2207 4101
Email
Amirhesam124@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirhesam Alirezaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Velenjak, Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2208 3095
Fax
+98 21 2208 3095
Email
aalirezaei@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirhesam Alirezaei
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
7th Floor, Bldg No.2 , Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Velenjak, Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2208 3095
Fax
+98 21 2208 3095
Email
aalirezaei@sbmu.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
د
Will be shared after data collection
When the data will become available and for how long
2017 December until april 2018
To whom data/document is available
Researchers
Under which criteria data/document could be used
For further evaluation and research
From where data/document is obtainable
Amirhesam alirezaei
What processes are involved for a request to access data/document
After requesting by email and explaining the purpose of the requesting party,Information will be provided to them.