The effect of Beta vulgaris extract on improvement of liver parameters in patients with non-alcoholic fatty liver
Design
randomized, double blinded, parallel group clinical trial with control group , 120 subjects
Settings and conduct
Patients referred to the gastroenterology clinic of Shahid Beheshti Hospital of Kashan with a diagnosis of non-alcoholic fatty liver, which patients and physicians do not know about medicine or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 70 years old; non-alcoholic fatty liver diagnosis.
Exclusion criteria: pregnancy and lactation; alcohol consumption; addiction; diabetes; cirrhosis and hepatitis.
Intervention groups
Intervention group: Prescribing Beta Vulgaris Extract
Control group: Placebo administration
Main outcome variables
Recovery of liver enzymes and fatty liver in ultrasound
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121017011145N20
Registration date:2018-05-18, 1397/02/28
Registration timing:registered_while_recruiting
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Mohammad Reza Sharif
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0026
Email address
sharif_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Beta vulgaris total extract effect on improvment of non-alcoholic fatty live disease factors
Public title
Evaluation of Beta vulgaris total extract effect on improvment of non-alcoholic fatty live disease factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAge 18-70 years old
Non-alcoholic fatty live disease diagnosis
Exclusion criteria:
Pregnancy and lactation
alcohol consumption
Drug addiction
Diabetes mellitus, cirrhosis, hepatitis
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Random unit: Individual
Randomization Tool: Random Numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients, physicians and statisticians are unaware of the type of medicine or placebo.
Placebo
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
Street address
Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
IR.TUMS.PSRC.REC.1396.4044
Health conditions studied
1
Description of health condition studied
Non – alcoholic fatty live disease
ICD-10 code
K76.1
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
Liver aminotransferases
Timepoint
Before starting treatment, three and six months after starting treatment
Method of measurement
ELISA test
2
Description
The severity of fatty liver
Timepoint
Before starting treatment, three and six months after starting treatment
Method of measurement
Liver ultrasound
Secondary outcomes
1
Description
Fasting Blood Glucose, Triglycerides, and Cholesterol
Timepoint
Before the intervention, three and six months after the intervention
Method of measurement
Biochemical laboratory tests
Intervention groups
1
Description
Intervention group: Beta-vulgaris extract capsule 400 mg daily (Institute of Medicinal Plants, Iran) for 6 months
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule daily (Institute of Medicinal Plants, Iran) for 6 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
بيمارستان شهيد بهشتي
Full name of responsible person
Hasan Afzali
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
hasanafsali@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Enghelab street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Kashan University of Medical Sciences
Full name of responsible person
Hasan Afzali
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
hasanafsali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hasan Afzali
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
hasanafsali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hasan Afzali
Position
hasanafsali@yahoo.com
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
hasanafsali@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available