The aim of this clinical trial is to study the effect of Silymarin on non alcoholic steatohepatitis in patients with nonalcoholic fatty liver disease. Fifty patients will be included. They are older than 20 years with nonalcoholic-fatty liver disease and liver enzymes> 50 and proportion of ALT/ AST> 1. The fatty liver will be recognized by sonography. Exclusion criteria are using drugs that affect liver tests during the last 2 months, viral hepatitis, hemochromatosis, autoimmune hepatitis, cirrhosis, diabetes mellitus, alcohol dependency, pregnancy, breast feeding, and infectious diseases. Intervention group will be administrated 140 mg of Silymarin BID during 6 month and control group will be given placebo. Liver enzymes and recovery of liver markers in sonography will be assessed after 6 months of treatment course.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138805172308N1
Registration date:2009-09-14, 1388/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-09-14, 1388/06/23
Registrant information
Name
Tarang Taghvaei
Name of organization / entity
Mazandaran Univercity of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1324 2615
Email address
ttaghvaeei@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-04-04, 1389/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Silymarin on Non Alcoholic Steatohepatitis
Public title
Effect of Silymarin on Non Alcoholic Steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: older than 20 years with nonalcoholic- fatty liver disease and liver enzymes> 50 and proportion of ALT/ AST> 1
Excluding criteria: using drugs that affect liver tests during the last 2 months, viral hepatitis, hemochromatosis, autoimmune hepatitis, cirrhosis, diabetes mellitus, alcohol dependency, pregnancy, breast feeding, and infectious diseases
Age
From 20 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Mazandaran University of Medical Sciences and Health Services
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
2009-08-26, 1388/06/04
Ethics committee reference number
88-64
Health conditions studied
1
Description of health condition studied
Non alcocholic steatohepatitis
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
AST
Timepoint
Before and 6 months after the therapy
Method of measurement
laboratory
2
Description
ALT
Timepoint
Before and 6 months after the therapy
Method of measurement
laboratory
3
Description
Sonographic markers
Timepoint
Before and 6 months after the therapy
Method of measurement
by Radiologist
Secondary outcomes
1
Description
Weight
Timepoint
Before and 6 month after the therapy
Method of measurement
balance
2
Description
BMI
Timepoint
Before and 6 months after the therapy
Method of measurement
Weight(kg)/height^2(m2)
3
Description
TG
Timepoint
Before and 6 months after the therapy
Method of measurement
laboratory
4
Description
FBS
Timepoint
before and 6 months after the therapy
Method of measurement
laboratory
Intervention groups
1
Description
Intervention group: 140 mg of Silymarin BID during 6 month
Category
Treatment - Drugs
2
Description
Contorol group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba clinic
Full name of responsible person
Torang Taghvaei
Street address
Tuba clinic - Khazar blv.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Sayed Jalal Hosseini mehr
Street address
Moalem SQ-2 Building
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences and Health Services
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
Mazandaran Univercity of Medical Sciences and Health Services
Full name of responsible person
Dr Torang Taghvaei
Position
Gastroenterologist/Faculty member
Other areas of specialty/work
Street address
Imam khomaini hospital-Razi street
City
Sari
Postal code
Phone
+98 15 1226 1700
Fax
Email
ttaghvaeei@mazums.ac.ir tarang_taghvaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaranl Univercity of Medical Sciences and Health Services
Full name of responsible person
Dr Torang Taghvaei
Position
Gastroenterologist/faculty member
Other areas of specialty/work
Street address
Imam Khomani hospital - Razi street
City
Sari
Postal code
Phone
+98 15 1226 1700
Fax
Email
ttaghvaeei@mazums.ac.ir tarang_taghvaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Millad Kasraei
Position
Medecine student
Other areas of specialty/work
Street address
Imam khomaini hospital - Razi street
City
Sari
Postal code
Phone
Fax
Email
milladxkz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)