The aim of our study is comparison of the effect of three different drugs: Pioglitazon and Metformin as insulin sensitizer, and silymarin as an anti oxidan in reduction of biochemical indices in patient with NASH. inclusion criteria were patients with NASH and exclusion criteria were DM, Alchole drinking, HBS Ag, HCV Ab.This randomized clinical trial lasted 2 mounths. 66 patient with NASH were divided randomly in three groups. Serum insulin, FBS, TG, Chol, AST and ALT were measured before and after treatment and BMI and HOMA index was calculated before and after treatment. The first group was treeted with Pioglitazon 15 mg, second group with Metformin 500mg and the third group with Silymarin 140 mg, daily. This study was double blind (Physision and patient).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105084849N2
Registration date:2011-05-28, 1390/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-28, 1390/03/07
Registrant information
Name
Amir Ziaee
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
aziaee@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- Cancellor for Reseserch of Medical University of Qazvin
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of metformin, pioglitazon and Silymarin on biochemical indices in patient with nonalcoholic fatty liver
Public title
The comparison of metformin, pioglitazon and Silymarin on biochemical indices
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria; patients with NASH;
rising of AST and ALT; evidence of fatty liver in ultrasound
and exclusion criteria; DM; Alchole drinking; HBS Ag; HCV Ab
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Science
Street address
Qazvin, Qazvin University of Medical Science
City
Qazvin
Postal code
Approval date
2011-11-28, 1390/09/07
Ethics committee reference number
28/20/4348
Health conditions studied
1
Description of health condition studied
Nutritional and metabolic disorders in diseases classified elsewhere
ICD-10 code
E90*
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere
Primary outcomes
1
Description
FBS
Timepoint
2 months after first measuring
Method of measurement
blood sampling
Secondary outcomes
1
Description
ALT
Timepoint
2 months after first measuring
Method of measurement
blood sampling
Intervention groups
1
Description
administration of 500mg metformin daily for 2 months
Category
Treatment - Drugs
2
Description
administration of 15mg pioglitazone daily for 2 months
Category
Treatment - Drugs
3
Description
administration of 140mg silymarin daily for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Of GI Diseases in Buali Hospital
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Cancellor for Research of Qazvin University of Medical Science
Full name of responsible person
Dr Saeed Asefzade
Street address
Qazvin, Qazvin University of Medical Science
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Cancellor for Research of Qazvin 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
Qazvin University of Medical Science
Full name of responsible person
Homa Masroor
Position
Resident of Internal Diseaes
Other areas of specialty/work
Street address
Qazvin, Buali Hospital
City
Qazvin
Postal code
Phone
+98 912 215 5438
Fax
Email
hshole@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Homa Masroor
Position
Resident of Internal Diseases
Other areas of specialty/work
Street address
Qazvin,Buali Hospital
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
hshole@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Elahe Sajadi
Position
M.S in Cell& Molecular Biology
Other areas of specialty/work
Street address
Qazvin, Buali Hospital
City
Qazvin
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)