This study is a randomized double-blind and controlled drug clinical trial on 90 patients over 18 years of non-alcoholic fatty liver disease based on ultrasound will be performed. In this study, patients devided randomly in 3 groups vitamin E 400+ placebo tablet or hepatoheal tablet( herbal remedy contain Vitis vinifera and Fragaria vesca)+ placebo pearl( 2 times of a day) or daily 1 hepatoheal tablet +vitamin E pearl 400 for 4 months. Exclusion criteria included a history of other liver disease, autoimmune disease and cancer, hepatotoxic drugs, and treatments and diet for fatty liver in the past 3months , pregnancy and lactation. at the beginning and end of the study, blood levels of aminotransferases are measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042612438N6
Registration date:2014-08-18, 1393/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-18, 1393/05/27
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Research Center of Medicinal Herbs
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hepatoheal tablet on liver enzymes of patients with non alcoholic fatty liver and its comparison with vitamin E
Public title
The effect of hepatoheal tablet on non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Both sexes; age >18; fatty liver on ultra sound; 25< BMI<40
exclusion criteria :ast/alt<1; pregnancy; breast feeding; alcohol; hormonal disorders; other liver diseases; hepatotoxic drugs; diet or treatment for fatty liver in 3 month past; autoimmune diseases and cancers.
Age
From 18 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Kashan University of Medical Science
Street address
Kashan University of Medical Science, Kashan
City
Kashan
Postal code
Approval date
2014-06-18, 1393/03/28
Ethics committee reference number
1398/1/5/29/پ
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Nonalcoholic fatty liver disease (NAFLD)
Primary outcomes
1
Description
ALT
Timepoint
beginning and end of study
Method of measurement
blood test
2
Description
AST
Timepoint
beginning and end of study
Method of measurement
blood test
3
Description
ALP
Timepoint
beginning and end of study
Method of measurement
blood test
Secondary outcomes
1
Description
HOMA-IR
Timepoint
beginning and end of study
Method of measurement
blood test
Intervention groups
1
Description
intervention:hepatoheal tablet+placebo pearl.2 times in day for 4 months.
Category
Treatment - Drugs
2
Description
control:vitamin E pearl+ placebo tablet.2 times in day for 4 months.
Category
Treatment - Drugs
3
Description
control:hepatoheal tablet+vitamin E pearl.2 times in day for 4 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Beheshti Hospital
Full name of responsible person
Street address
Shahid Beheshti Hospital, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
Miss L.Hejazi
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Research Center of Medicinal Herbs
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
Kashan University of Medical Science
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Other areas of specialty/work
Street address
Kashan University Of Medical Science, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Dr Mohsen Razavizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Kashan University of Medical Science, Kashan
City
Kashan
Postal code
Phone
+86 3615550026
Fax
Email
razavizadeh_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Barij Research Center of Medicinal Herbs
Full name of responsible person
M.Mahlouji
Position
Clinical Expert
Other areas of specialty/work
Street address
Kashan Mashhad Ardehal Road, KM44
City
Kashan
Postal code
Phone
+98 86 4446 5112
Fax
Email
mahnaz.mahlouji@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)