The aim of this study was to evaluate the effect of silymarin and vitamin E on liver enzymes of non-alcoholic steatohepatitis patients who referred to Shahid Mofatte Clinic of Yasuj in 2016-2017. Patients who had evidence of non-alcoholic steatohepatitis in sonography and increased liver enzymes were included in the study. Secondary causes of elevated liver enzymes were also excluded. This clinical trial study was performed on 114 patients with non-alcoholic steatohepatitis. Patients were randomly allocated into three groups (1.1.1 ratio) and treated with silymarin; vitamin E; vitamin E and silymarin for 3 months. Diet and exercise program were recommended to all patients. Before and after treatment for all patients, liver enzymes were measured and compared in three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111322869N2
Registration date:2017-08-30, 1396/06/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-30, 1396/06/08
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Science
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of silymarin and vitamin E on liver enzyme of nonalcoholic steatohepatitis patients: results of a randomized clinical trial
Public title
Evaluation of effect of Livergol and vitamin E on liver enzyme of nonalcoholic steatohepatitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Major inclusion criteria: Diagnosis of non-alcoholic steatohepatitis disease by sonography and elevated liver enzymes; negative history of autoimmune hepatitis, viral hepatitis, Wilson disease, hemochromatosis, α-1 antitrypsin deficiency, diabetes, hypothyroidism, cardio-pulmonary disease, kidney disease, psychiatric disease, pregnancy, alcohol consumption; also negative history for using lipid lowering drugs such as atorvastatin and gemfibrozil, estrogen, tamoxifen, corticosteroids, amiodarone, acetaminophen more than 2 grams per day, chemotherapy drugs in six months ago, anti-seizure medications such as sodium valproate, carbamazepine, phenytoin, anti-tuberculosis drugs such as isoniazid, rifampin, perazinamide.
Major exclusion criteria: Patient’s displeasure to continue participation in the study; The incidence of drug-related complications.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not 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 Yasuj University of Medical Science
Street address
Yasuj University of Medical Science, Motahari street, Yasuj city
City
Yasuj
Postal code
75917-41417
Approval date
2016-12-27, 1395/10/07
Ethics committee reference number
IR.YUMS.1395.134
Health conditions studied
1
Description of health condition studied
fatty liver disease
ICD-10 code
K75.8
ICD-10 code description
nonalcoholic steatohepatitis
Primary outcomes
1
Description
aspartate aminotransferase
Timepoint
3 month
Method of measurement
International Unit per Milliliter
2
Description
alanine aminotransferase
Timepoint
3 month
Method of measurement
International Unit per Milliliter
Secondary outcomes
1
Description
Drug reaction
Timepoint
3 month
Method of measurement
Questionnaire
Intervention groups
1
Description
silymarin, tablet 140 milligram parenteral, daily for 3 month
Category
N/A
2
Description
Vitamin E,tablet 400 unit parenteral, daily for 3 month
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofatte clinic
Full name of responsible person
moslem sedaghattalab
Street address
Yasuj, Shahrdari street, Shahid Mofatte clinic
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
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 of Yasuj University of Medical Sciences