The aim of this study is effects of Garlic on liver enzymes ,body composition and sonographic findings in patients with Non-Alcoholic Fatty Liver Disease.
In this randomized, double blind trial,100 patients suffering from fatty liver disease will be selected among patients referring to Endocrinology and Metabolism Research Center in Isfahan , and will be assigned into intervention or control group.
Exclusion criteria are pregnancy; breast feeding; alcohol; other liver diseases; diet or treatment for fatty liver in 3 month past; autoimmune diseases and cancers.
At the beginning and end of the study, blood levels of alanin aminotranspherase and aspartat aminotranspherase, body composition and ultra sonography will be taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110819853N1
Registration date:2014-12-18, 1393/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-18, 1393/09/27
Registrant information
Name
Zamzam Paknahad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3166
Email address
paknahad@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of garlic on liver function, sonographic findings and body composition in patients with Non-Alcoholic Fatty Liver Disease
Public title
Effect of garlic on patients with Non-Alcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :60> age >20;serum level of alanin aminotranspherase and aspartat aminotranspherase more than 40; fatty liver on ultra sound.
exclusion criteria : pregnancy; breast feeding; alcohol; other liver diseases; diet or treatment for fatty liver in 3 month past; autoimmune diseases and cancers.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Isfahan University of Medical Sicences
Street address
Hezar Jarib Street
City
Isfahan
Postal code
8174673461
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
393637
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
ALT
Timepoint
before and 15 weeks after intervention
Method of measurement
photometric
2
Description
AST
Timepoint
before and 15 weeks after intervention
Method of measurement
photometric
3
Description
The severity of fatty liver
Timepoint
before and 15 weeks after intervention
Method of measurement
ultrasound
Secondary outcomes
1
Description
body composition
Timepoint
befor and 3 month of intervention
Method of measurement
instrument body composition
2
Description
FBS
Timepoint
befor and 3 month of intervention
Method of measurement
photometric
Intervention groups
1
Description
Intervention group: Garlic Tab 400 mg 2 times in day for 15 weeks (each tablet contains 1500 microgram allicin)
Category
Treatment - Drugs
2
Description
Control groups: tablet of starch، 2 times per day for 15 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Institute
Full name of responsible person
Paknahad
Street address
Khoram Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Paknahad
Position
Ph.D of Nutrition Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 3792 2784
Fax
+98 31 3668 2509
Email
paknahad@hlth.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Paknahad
Position
Ph.D of Nurition Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 3792 2784
Fax
+98 31 3668 2509
Email
paknahad@hlth.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Paknahad
Position
Ph.D of Nurition Sciences
Other areas of specialty/work
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Phone
+98 31 3792 2784
Fax
+98 31 3668 2509
Email
paknahad@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)