Objectives: Non alcoholic fatty liver disease is one of the most common liver diseases of adults so that its prevalence is also increasing in children and adolescents. It is the most predisposing factor for liver cirrhosis in adults. Due to complications of non alcoholic fatty liver disease, the treatment of this disease is essential. Recently silymarin is recommended for treatment of non alcoholic fatty liver disease in adults. Since this study have not been done in Iranian children and adolescents, we decided to evaluate the effect of this herbal medication on non alcoholic fatty liver disease in children and adolescents.
Design: This is a randomized cross sectional case control double blind clinical trial study, which is done in Shahre-kord University of Medical Science. This study is done on over weight or obese 5-16 years old children and adolescents with evidence of fatty liver in sonography that other causes of fatty liver ruled out for them. Then,Participants were randomized to treatment or placebo groups through random table numbers containing 20 patients in each group. Livergol tablet containing silymarin(Goldaru Company, Iran) were administered for 12 weeks with dosage of 5 mg per kg body weight divided in three dose with meal. However, only changing life style including exercise was advised in the control group. Liver sonography and liver function test are done at arrival to study and after 12 weeks. Participants is followed each months for antropometric measures and compliance to instructions. The first outcome measure changes in sonographic grading of fatty liver. The second outcome measure is liver enzymes changes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080614882N4
Registration date:2016-09-17, 1395/06/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-17, 1395/06/27
Registrant information
Name
Fatemeh Famouri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 7291
Email address
famouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahrekord University of Medical Science
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sylimarin effect on non alcoholic fatty liver on children and adolescents
Public title
Effect of sylimarin in treatment of fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Obese or overweight child and adolescent with sonographic finding of
fatty liver
Exclusion criteria: Age less than 5 and more than 16 years old; patients with metabolic syndromes; viral hepatitis; wilson disease; auto immune hepatitis; juvenile hemochromatosis and other underlying diseases; allergy or intolerance to medication
Age
From 5 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was done base of random table number
Secondary Ids
1
Registry name
Fatemeh Famouri
Secondary trial Id
14882
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord university of medical science
intervention group : Livergol tablet containing silymarin(Goldaru Company, Iran) were administered for 12 weeks with dosage of 5 mg per kg body weight divided in three dose with meal. Patients are visited weight, height and compliance to medication each month.
Category
Treatment - Drugs
2
Description
Control group: life style change including increase in physical activity and decease ingestion of fatty and high calori diets.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Out patient department of Hajar hospital, Hajar hospital related to ُShahrekord University of Medica
Full name of responsible person
Dr. Fatemeh Famouri, Pediatric Gastroentrology and Hepatologist
Street address
Shahrekord, Parastar street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Mahmood Mobasheri
Street address
Shahrekord Setad Daneshgah
City
Shahrekord
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahrekord University of Medical Science
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 Science
Full name of responsible person
Dr.Fatemeh Famouri
Position
Assistant professor of pediatric gastroenterology and hepat
Other areas of specialty/work
Street address
Imam hosein hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3386 6266
Fax
Email
famouri@med.mui.ac.ir;fat.famoori@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahreord univrsity of medical science
Full name of responsible person
Fatameh Famouri
Position
Assistant professor of pediatric gastroenterology and hepatologist
Other areas of specialty/work
Street address
Imam Hosein hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3386 6266
Fax
Email
famouri@med.mui.ac.ir;fat.famoori@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of medical science
Full name of responsible person
Dr.Fatemeh Famouri
Position
Assistant professorof pediatric gastroentrology and hepatology
Other areas of specialty/work
Street address
Imam Hosein hospital, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3386 6266
Fax
Email
famouri@med.mui.ac.ir;fat.famoori@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)