Proof of Losartan Effect on Improvement of Laboratory Indices and Non-Alcoholic Staphylococcus aureus
Design
In this study, 42 patients with non-alcoholic steatohepatitis who are eligible to enter the study, who are referred to Gastroenterology and Internal Medicine Clinic of Amir Al-Momenin Hospital and Imam Reza Arak Clinic, are selected. Participants are randomly divided into intervention and control groups and assigned a code to hide the intervention group of each participant.
Settings and conduct
The study was performed on patients with non-alcoholic fatty liver who referred to the internal and gastrointestinal clinic of Amiralmomenin Hospital and Imam Reza city of Arak. They were randomly assigned to one of the control and case groups. The case group was treated with losartan and the control group to be treated with placebo, and in order to hide the intervention, each participant is assigned a code.
Participants/Inclusion and exclusion criteria
Patients with non-alcoholic steatohepatitis who have not had other causes of hepatic steatosis, who have high blood pressure, have not received angiotensin-blocking drugs and ACE inhibitors over the past year, and have not been resistant to hypertension.
Intervention groups
The losartan group will receive a dose of 50 mg per day and will be given to patients in the placebo control group for 6 months.
Main outcome variables
AST, ALT, ALKP, liver ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031316N2
Registration date:2018-02-13, 1396/11/24
Registration timing:retrospective
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Moosa Abdollahi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3639
Email address
m.abdollahi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
11017000
Expected recruitment start date
2016-11-01, 1395/08/11
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of losartan in nonalcoholic steatohepatitis
Public title
Nonalcoholic fatty liver treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-alcoholic steatohepatitis and liver enzymes are based on indicators of liver function and ultrasound
Age over 18 years
Exclusion criteria:
alcohol
intake of angiotensin receptor antagonists
use of angiotensin converting enzyme inhibitors
resistance-resistant hypertension
Uncontrolled Diabetes
hypotension
serious interactions with other patient medications
other causes of liver steatosis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
In a simple random method, using a flip the coin, they enter one of the groups or control.
Blinding (investigator's opinion)
Single blinded
Blinding description
For both groups, placebo capsules with similar characteristics will be used, and none of the patients will be aware of the two groups of received drugs, and the two groups will be followed up and examined and the investigator will be aware of the patient's drug intake.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
meydan e basij
City
Arak
Province
Markazi
Postal code
38481-7-6941
Approval date
2016-08-22, 1395/06/01
Ethics committee reference number
IR.ARAKMU.REC.1395.203
Health conditions studied
1
Description of health condition studied
NASH
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Serum creatinin
Timepoint
Measurement of serum creatinine at baseline (before intervention) and 7 days and 1.3.6 months after initiation of losartan administration
Method of measurement
by Laboratory
2
Description
Serum potasium
Timepoint
Serum potassium measurements at the beginning of the study (before intervention) and 7 days and 1.3.6 months after the start of losartan administration
Method of measurement
by Laboratory
3
Description
Serum Alkaline phosphatase
Timepoint
Measurement of serum alkaline phosphatase at baseline (before intervention) and 3.6 months after initiation of losartan administration
Method of measurement
by Laboratory
4
Description
Serum Alanine aminotransferase
Timepoint
Measurement of serum alanine aminotransferase at baseline (before intervention) and 3.6 months after initiation of losartan administration
Method of measurement
by Laboratory
5
Description
Serum Aspartate aminotransferase
Timepoint
Measurement of serum aspartate aminotransferase at baseline (before intervention) and 3.6 months after initiation of losartan administration
Method of measurement
by Laboratory
6
Description
Blood pressure
Timepoint
Blood pressure measurement at the beginning of the study (before the intervention) and 1,2,3,4,5,6 months after the start of losartan administration
Method of measurement
Barometer
7
Description
Body Mass Index
Timepoint
Measuring the body mass index at the beginning of the study (before the intervention) and 3.6 months after starting the administration of losartan
Method of measurement
Meter , Balance
8
Description
Liver ultrasound indices
Timepoint
Measurement of liver ultrasonography at the beginning of the study (before the intervention) and 3.6 months after the start of administration of losartan
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo for 6 month
Category
Treatment - Drugs
2
Description
Intervention group 1: Losartan (abidi: lostar) 25 mg daily for 6 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Moosa Abdollahi
Street address
Amiralmomenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3630
Email
moosadr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Sardasht Square, Arak Medical Faculty, Department of Research and Research and Information Technology
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Fax
+98 86 3417 3645
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Azim Forozan
Position
Gastroenterologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amiralmomenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Fax
Email
a.forozan@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Azim Forozan
Position
Gstroentrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amiralmomenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Fax
Email
a.forozan@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Moosa Abdollahi
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sardasht, Basij square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3639
Fax
+98 86 3417 3639
Email
moosadr@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
In this study, after unidentification, all the study data, including demographic information, paraclinical outcomes and the results of the study, including the results of tests and paraclinic and the treatment complications, will be published.
When the data will become available and for how long
Concurrent with the publication of the study results
To whom data/document is available
Researchers in Medical Sciences
Under which criteria data/document could be used
For further research, researchers will be able to access data from the research vice president.
From where data/document is obtainable
Supervisor
What processes are involved for a request to access data/document
First, you must contact the supervisor by email, and then the supervisor handles the request with the deputy investigator and, if approved, provides the supervisor or documentary master with the requester.