Objectives: Determine the effect of losartan on liver function tests in patients with non alcoholic steatohepatitis (NASH) .
Design: Prospective randomized clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: One hundred patients, with age 18-60 yr ; candidates for the treatment of chronic hypertension in Sina Hospital during 2016-2017, were included. Patients were randomized into two groups of 50 each, using a table of random numbers.
Intervention: Intervention group , patients received oral tablets Losartan 50 mg daily for six months and control group , patients received oral tablets Amlodipine 5 mg for six months.
Main outcome measures (variables): Liver function tests (Aspartate aminotransferase; Alanine aminotransferase; Alkaline phosphatase); Triglycerides; cholesterol.
In each group, drug type are coded by individual not aware of the research process.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060628305N1
Registration date:2016-08-14, 1395/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-14, 1395/05/24
Registrant information
Name
Alireza Sharifi
Name of organization / entity
Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8533
Email address
sharifra@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2016-07-26, 1395/05/05
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of losartan drug on liver function tests in patients with non alcoholic steatohepatitis (NASH)
Public title
Effects of losartan tablets in the treatment and modification of liver function in patients with non-alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years old; Chronic hypertension.
Exclusion criteria:
Viral hepatitis; Human immunodeficiency virus positive; Pregnancy; Diabetes; Daily alcohol consumption; Use of drugs affecting liver enzymes in the last 6 months; A history of liver disease; Kidney disease; Chronic debilitating disease; Gastrointestinal bleeding active in the last 6 months ; Consumption previous and current weight loss or lipid drugs; Anti-TNFα; Stimulant drugs insulin; Metformin ; Vitamin E; Pentoxifylline
Age
From 98 years old to 56 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Tehran University of Medical Sciences and Health Services
Street address
Poursina St.
City
Tehran
Postal code
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
IR.TUMS.REC.1395.2760
Health conditions studied
1
Description of health condition studied
Liver function in non alcoholic steatohepatitis (NASH) patients
ICD-10 code
R94.5
ICD-10 code description
Abnormal results of liver function studies
Primary outcomes
1
Description
Aspartate aminotransferase
Timepoint
Before starting treatment, every two months to six months after treatment
Method of measurement
Blood sample
2
Description
Alanine aminotransferase
Timepoint
Before starting treatment, every two months to six months after treatment
Method of measurement
Blood sample
3
Description
Alkaline phosphatase
Timepoint
Before starting treatment, every two months to six months after treatment
Method of measurement
Blood sample
4
Description
Triglyceride
Timepoint
Before starting treatment, every two months to six months after treatment
Method of measurement
Blood sample
5
Description
Cholesterol
Timepoint
Before starting treatment, every two months to six months after treatment
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, Losartan 50 mg tablet taken orally, once a day for six months
Category
Treatment - Drugs
2
Description
In the control group, Amlodipine 5 mg tablets orally, once a day for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Alireza Sharifi MD.
Street address
Imam Khomeini st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhunzadeh P.H.D
Street address
Poursina St.
City
Tehran
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, Tehran University of Medical Sciences and Health Services
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
Sina Hospital
Full name of responsible person
Alireza Sharifi MD.
Position
Subspecialty of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
sharifra@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Alireza Sharifi MD.
Position
Subspecialty of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Imam Khomeini st.
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
sharifra@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Alireza Sharifi MD.
Position
Subspecialty of Gastroenterology and Hepatology
Other areas of specialty/work
Street address
Imam Khomeini st.
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
sharifra@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)