The main aim of this study is to investigate the effect of Silymarin, Metformine, and Vit E on liver enzymes levels in fatty liver patients. 135 patients with fatty liver are recruited and randomly assigned into three equal number groups to receive Silymarin receive 70 mg daily, Metformine 500mg twice daily, or vitamin E 400 mg daily for two months. Liver enzymes are measured in all patients and changes are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902253933N1
Registration date:2010-04-21, 1389/02/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-21, 1389/02/01
Registrant information
Name
Nadia Asadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 4889
Email address
mtaran@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Survey effect of Selimarine, Vit E, and Metformine in nonalcoholic fatty liver patients
Public title
To Survey effect of Selimarine, Vit E, and Metformine in nonalcoholic fatty liver patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of fatty liver
Exclusion criteria: alcoholism, another disease such as viral Hepatitis, pregnancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Emam Reza Haspital, Baghe abrisham, Kermanshah
City
Kermanshah
Postal code
Approval date
2009-10-13, 1388/07/21
Ethics committee reference number
29981/420/7
Health conditions studied
1
Description of health condition studied
Nonalcoholic Fatty liver
ICD-10 code
K71, K72,
ICD-10 code description
Diseases of the digestive system
Primary outcomes
1
Description
Serum levels of liver enzymes
Timepoint
before intervention, 2 months after intervention
Method of measurement
Counter
Secondary outcomes
empty
Intervention groups
1
Description
Metformine (oral tablet, 500mg twice daily for 2 months)
Category
Treatment - Drugs
2
Description
Silymarin (oral tablet, 70 mg daily for 2 months)
Category
Treatment - Drugs
3
Description
Vit E (oral tablet, 400 mg daily for 2 months)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Asadi
Street address
Emam reza haspital
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah Universityof Medical Sciences
Full name of responsible person
Nadia asadi
Position
Internal resident
Other areas of specialty/work
Street address
Emam Reza Haspital, Baghe abrisham, Kermanshah
City
Kermanshah
Postal code
Phone
+98 918 336 6476
Fax
Email
mtaran@razi.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nadia Asadi
Position
Internal resident
Other areas of specialty/work
Street address
Emam Reza Hospital, Baghe abrisham, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6317
Fax
Email
mtaran@razi.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nadia Asadi
Position
Internal Resident
Other areas of specialty/work
Street address
Emam Reza Hospital, Baghe Abrisham, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6317
Fax
Email
mtaran@razi.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)