This study aims to investigate the effect of silimarin in overweight, obese and Hyperlipidemic or apparently healthy children who have fatty liver disease manifestations in ultrasound. Liver enzymes, cholesterol and triglycerides are measured and patients are randomly divided into two groups. Patients have a special code and will be studied double-blindly. In case of alcohol drink and receiving hepatotoxic drugs, B, C and autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin, heart and lung diseases and liver cirrhosis, patients are excluded. Patients were divided into two groups and each group of 40 children will be studied. A group receives 140mg silimarin capsule three times a day and the other group receives placebo capsule for three months. After a one month washout period, the groups are displaced to a three-month placebo or silimarin treatment. The groups are age and sex matched. The patients are followed up monthly for drug side effects and drug usage. At the end of 3 months, liver ultrasound and measuring liver enzymes are done and results are collected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012520781N1
Registration date:2015-04-04, 1394/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-04, 1394/01/15
Registrant information
Name
Hanieh Hajian
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3772 7171
Email address
hhajian@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology, Qom University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of silimarin in children with nonalcoholic fatty liver disease
Public title
Effect of silimarin on non-alcoholic fatty liver disease in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Obese children with non-alcoholic fatty liver manifestations in ultrasonography.
Exclusion criteria : Use of ethanol; use of hepatotoxic drugs; hepatitis B and C; autoimmune hepatitis; Wilson disease; Hemochromatosis; alpha-1 antitrypsin; severe coronary disease; severe lung disease; liver cirrhosis
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qom University of Medical Sciences
Street address
Qom- Saheli Streeet-Qom University of Medical Sciences
City
Qom
Postal code
3719764799
Approval date
2014-12-03, 1393/09/12
Ethics committee reference number
14765/34/پ
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
AST
Timepoint
Before and after the treatment
Method of measurement
mg/dL
2
Description
ALT
Timepoint
Before and after the treatment
Method of measurement
mg/dL
3
Description
Fatty liver disease stage
Timepoint
Before and after the treatment
Method of measurement
Ultrasonography
4
Description
TG
Timepoint
Before and after the treatment
Method of measurement
mg/dL
5
Description
HDL
Timepoint
Before and after the treatment
Method of measurement
mg/dL
6
Description
LDL
Timepoint
Before and after the treatment
Method of measurement
mg/dL
Secondary outcomes
empty
Intervention groups
1
Description
In the case group Silimarin capsule manufactured by Sabz Daroo company with dose of 140 mg three times a day is used for 3 months
Category
Treatment - Drugs
2
Description
In the control group placebo capsule filled with starch, made by the researcher is used three times a day for 3 months