The goal of this study is comparison the effect of Ursobil and Silymarin in treatment of non-alcoholic fatty liver. This study will be performed on 70 patients as double center randomized clinical trial at Velayat and Buali hospitals in Qazvin city. Patients will be selected by randomized method (closed envelopes method and selecting coloured card). Selecting method of patients will be done via sonography confirmation based on fatty liver and increased level of liver enzymes. Persons with Alcoholic cases, hepatotoxic drug users, cases with viral hepatitis and liver metabolic disorder will be excluded. Then patient will be divided into two groups (each include 35 members). Before intervention we will measured liver enzymes, fasting blood sugar, inflammatory marker, lipid profile and serum insulin by laboratory analysis (blood test). After that the first group will be treated with Cap Ursobil 300 mg twice a day and the second group with Tab Silymarin 140mg twice a day for 4 weeks at home. At the end of 4 weeks, we will also measure the pervious parameters and will be compared with baseline values.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040727265N1
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Nazanin Ghorbanian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
ghorbanian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-16, 1394/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Ursobil and Silymarine in non alchoholic fatty liver
Public title
Comparison of the effect of Ursobil and Silymarine in fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Confirmation of NAFLD with ultra sonography; increased level of liver enzymes.
Exclusion criteria: Alcoholism; hepatotoxic drug users; viral hepatitis and liver metabolic disorder.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
3419759811
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.QUMS.REC.1394.842
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.8
ICD-10 code description
nonalcoholic steatohepatitis
Primary outcomes
1
Description
Liver enzymes
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
By laboratory analysis ( blood test)
2
Description
Serum insulin
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Chemiluminescence
3
Description
Fasting blood sugar
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
By laboratory analysis ( blood test)
4
Description
Lipid profile
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
By laboratory analysis ( blood test)
5
Description
Inflammatory marker
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
By laboratory analysis ( blood test)
Secondary outcomes
empty
Intervention groups
1
Description
First group will be received Ursobil (oral capsule; 300mg BD for 4 weeks)
Category
Treatment - Drugs
2
Description
Second group will be received Silymarin (oral tablet ; 140 mg BD for 4 weeks)