Outpatient clinic of Shahid Motahari hospital (Marvdasht) during 6 months period.
Participants/Inclusion and exclusion criteria
Patients aged between 18 to 60 years with probable diagnosis of NAFLD in liver sonography with or without increased levels of liver enzymes will be enrolled in the study. Exclusion criteria includes a history of alcohol consumption, diabetes, and chronic liver disease.
Intervention groups
The patients will be randomly allocated into three study groups; group A subjects were treated with only lifestyle modification and placebo. Group B subjects were administered with lifestyle modification and Metformin 500 mg/day. Group C subjects with lifestyle modification and Silymarin 140 mg/day. Treatment courses were considered for three months.
Main outcome variables
The primary outcome is biomarker changes of liver function test at initial and 3 months after intervention. In addition, we will be considered BMI as secondary outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121105011375N5
Registration date:2018-05-10, 1397/02/20
Registration timing:prospective
Last update:2018-05-10, 1397/02/20
Update count:0
Registration date
2018-05-10, 1397/02/20
Registrant information
Name
pouya farhadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1625 4206
Email address
farhadip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of silymarin, metformin, and life style in patients with non-alcoholic fatty liver disease in Marvdasht Hospital
Public title
Effect of Silymarin, Metformin, and life style in non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with NAFLD confirmed by performing liver sonography
Increased levels of liver enzymes AST and ALT
Exclusion criteria:
History of alcohol consumption
Diabetes
Chronic liver disease
Use of drugs such as statin, fibrate
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a randomization table based on the registration number of the patients. Study pills will be allocated in separate packs blinded and labeled using a four-digit code.
Blinding (investigator's opinion)
Double blinded
Blinding description
Apart from the outcome assessor, patients, care provider, investigator, and members collecting and analyzing data will be blinded to the intervention allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
71348-45794
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.SUMS.MED.REC.1397.05
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Liver function test
Timepoint
Before intervention, 3 months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before intervention, 3 months after intervention
Method of measurement
By BMI Formula
Intervention groups
1
Description
Intervention group: lifestyle modification and Metformin 500 mg/day for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: lifestyle modification and Silymarin 140 mg/day for 3 months
Category
Treatment - Drugs
3
Description
Control group: lifestyle modification and placebo for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital and Clinic
Full name of responsible person
Amir Anushiravani
Street address
Motahari hospital and clinic, Moalem Square
City
Marvdasht
Province
Fars
Postal code
71879-15998
Phone
+98 71 3634 4292
Email
anushirvan@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maedeh Pourfarmanbar
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Shiraz Medical School, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-45794
Phone
+98 71 3230 5645
Email
taranehh99@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Mohammad Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Nemazee Hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4332
Email
mohamadkv@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Vahid Mohammad Karimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, Nemazee Hospital, Zand Ave
City
Shiraz
Province
Fars
Postal code
71937-11351
Phone
+98 71 3647 4332
Email
mohamadkv@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The patients will be randomly divided into three study groups; group A subjects will be treated with only lifestyle modification and placebo. Group B subjects will be administered with lifestyle modification and Metformin 500 mg/day. Group C subjects will be received lifestyle modification and Silymarin 140 mg/day. The primary outcomes are biomarker changes including AST, ALT, FBS, TG, CHOL, LDL, and HDL at initial and 3 months after intervention. In addition, we will be considered BMI, and waist circumference as secondary outcomes. All data related to the patients will be shared after deidentifing the patients.
When the data will become available and for how long
starting 1 month after publication
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
All statistical analysis are allowed in line with the objectives of the study.
Application terms for access to data including:
People working in academic institutions who have registered a protocol liked our study. People are committed to data protection.
From where data/document is obtainable
Vahid Mohammad Karimi, Shiraz Nemazee Hospital, Email: mohamadkv@sums.ac.ir
What processes are involved for a request to access data/document