This study will be done with aim to investigate the effectiveness of Rosa canina on liver enzymes in patients with nonalcoholic fatty liver. This study is a double blind clinical trial. The study population will be included all patients with fatty liver refer to Red Crescent Clinic of Kermanshah University of Medical Sciences. A total of 70 eligible patients will be selected and will be assigned into two experimental and control groups via block randomization method. In the first stage before the intervention (pre-test), blood sample will be taken from the brachial vein of all people once, after 12 to 14 hours of fasting and about 24 hours before the first practice session. In the intervention group dog rose fractions (fraction of Rosa canina, gelatin solution5% and avicel) will be administered for 8 weeks and the control group will receive placebo (lactose powder, gelatin solution5%, and avicel) for 8 weeks. About 48 hours after the last date of treatment and 12 to 14 hours of fasting, blood samples will be taken again and the liver enzymes will be compared in both groups
Inclusion criteria: Diagnosis of non-alcoholic fatty liver disease based on AST and ALT level more than 30 in men and more than 20 in women and also liver ultrasound; Aged between 30-65 years; BMI greater than 25.
Exclusion criteria: Using drugs that affect the liver; The risk of diseases that require special treatment; pregnancy during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011514333N65
Registration date:2017-03-09, 1395/12/19
Registration timing:na
Last update:
Update count:0
Registration date
2017-03-09, 1395/12/19
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effectiveness of Rosa canina on liver enzymes in patients with nonalcoholic fatty liver
Public title
Effect of Rosa canina on non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of non-alcoholic fatty diseases based on AST and ALT level more than 30 in men and 20 in women and also liver ultrasound; Aged between 30-65 years; BMI greater than 25;
Non-use of antioxidant supplements during one month prior to sampling; Non-acute cardiac disease, renal, infectious, diabetes, hepatitis B or C and other liver diseases; Not being on an intense increasing or decreasing diet weight during the last three months prior to sampling; lack of effective drugs on weight during the last three months prior to sampling; not using medications that may be associated with the disease (methotrexate, amiodarone, tamoxifen, corticosteroids, valproic acid).
Exclusion criteria: Not wanting to continue the study; Use of drugs that affect the liver; The risk of diseases that require special treatment; pregnancy during the study.
Age
From 30 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Randomization will be done via block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
Approval date
2017-01-11, 1395/10/22
Ethics committee reference number
kums.rec.1395.593
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver(NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
liver enzymes
Timepoint
Baseline, 48 hours after the end of the study (study will take 8 weeks)
Method of measurement
Based on the results of blood tests (including ALT and AST)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive a 500 mg pill containing dog rose fractions (fraction of Rosa canina, gelatin solution5% and avicel) per day for 8 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive a 500 mg placebo pill containing lactose powder, gelatin solution5%, and avicel, per day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent clinics Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Rozita Nasseri
Street address
Azadi Square
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
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, Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Farzaei
Position
Pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3426 6780
Fax
Email
Mh.farzaei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Rozita Nasseri
Position
Endocrinologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 834276301
Fax
Email
rnasseri.75@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Farzaei
Position
Pharmacist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 834266780
Fax
Email
Mh.farzaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)