Purpose: With the use of different methods of treatment for the prevention and treatment of NAFLD in this studyاhas compared 3 methods of treatment used in these patients should be done.
Study design: The study was double-blind and randomized clinical trial
population: patients with a diagnosis NAFLD referred to the gastroenterology clinic Main inclusion criteria: elevated liver enzymes more than 1.5 to 2 times normal. Or the presence of fatty liver include Grade 1 and above
Main exclusion criteria: .Hepatitis B and hepatitis C (HBs Ag, HCV Ab) . Alcoholic liver disease (more than 20 grams of alcohol consumed more than 10 g in men and women) autoimmune liver disease, The use of drugs with liver toxicity during the last 6 months . severe systemic disease, metabolic liver disease, (Wilson - hemochromatosis -a1 antitrypsin)
Sample size: 60 patients were assigned to three groups of 20 patients each were randomly divided . NAC 600 mg daily for the first group and the second group one gram daily of metformin and pioglitazone 30 mg administered to the third group. After 2 months pationts will evaluatesin changes of liverenzymesand fatty liver ultrasound evidences. Finally, a comparison will be made of the three drugs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309188308N3
Registration date:2015-02-23, 1393/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Javad Kiani
Name of organization / entity
College of Medical Sciences, Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0155
Email address
javadkiani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-11-18, 1393/08/27
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectivness of N-Acetylsyctein, Pioglitazon and Metformin in the treatment of non alcoholic fatty liver disease
Public title
Treatment of NAFLD with N-Acetylsyctein, Pioglitazon and Metformin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Elevated liver enzymes > 1.5 times
2) Sonographic diagnosis of NAFLD (Grade 1 and more)
Exclusion criteria:
1) Viral hepatitis
2) Alcoholic liver disease
3) Autoimmune liver disease
4) Hepatotoxic drug use in the past 6 month
5) Systemic illness
6) Metabolic liver disease
7) Active drug abuse
8) Pregnancy
9) Diabetes mellitus
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Research Ethics committee
Street address
Hamedan University of Medical Scinces, Shahid fahmide street
City
Hamedan
Postal code
6517619651
Approval date
2013-06-12, 1392/03/22
Ethics committee reference number
D/P/16/35/9/1281
Health conditions studied
1
Description of health condition studied
Non Alcoholic Fatty Liver Disease
ICD-10 code
K75.8
ICD-10 code description
Nonalcoholic steatohepatitis
Primary outcomes
1
Description
Liver enzymes
Timepoint
two month
Method of measurement
Labratory
Secondary outcomes
1
Description
Grading of Steatosis
Timepoint
two month
Method of measurement
Sonography
Intervention groups
1
Description
Third group: metformin tablets 500 mg every 12 hours for two months
Category
Treatment - Drugs
2
Description
Second group pioglitazone 30 mg tablets for two months
Category
Treatment - Drugs
3
Description
First group: N-acetylcysteine 600 mg tablets for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Shahid Beheshti Hospital
Full name of responsible person
Dr.mehdi rezvan
Street address
shahid beheshti hospital.Eram avenu.Hamedan. Iran
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of Medical Sciences of Hamedan
Full name of responsible person
Dr.mohammad yoosef alikhani
Street address
Vice Chancellor for Research and Technology University of Medical Sciences of Hamedan.shahid fahmide avenu.Hamedan.Iran
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology University of Medical Sciences of Hamedan
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
University of Medical Sciencesof Hamedan
Full name of responsible person
ِDr.Mehdi.Rezvan
Position
Internal Medicine residents
Other areas of specialty/work
Street address
Internal medicin department.medical univercity of hamedan.shahid fahmide avenu.Hamedan. Iran
City
Hamedan
Postal code
6516718747
Phone
+98 81 3838 5914
Fax
+98 32640089
Email
drmrezvan@gmail.com
Web page address
http://www.umsha.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan univercity of Medical sciences
Full name of responsible person
Dr.Alireza Khalilian
Position
Assistant professor
Other areas of specialty/work
Street address
Internal Medicin Department ofmedical univercity. shahid fahmide aveneu. Hamedan univercity of Medical sciencesHamedan. Iran
City
Hamedan
Postal code
۶۵۱۷۶۱۹۶۵۱
Phone
+98 81 3252 0683
Fax
+98 32640089
Email
ar.khalilian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciencesof Hamedan
Full name of responsible person
ِDr.Mehdi.Rezvan
Position
Internal Medicine residents
Other areas of specialty/work
Street address
Internal medicin department.medical univercity of hamedan.shahid fahmide avenu.Hamedan. Iran
City
Hamedan
Postal code
6516718747
Phone
+98 81 3838 5914
Fax
+98 32640089
Email
drmrezvan@gmail.com
Web page address
http://www.umsha.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)