Treatment of NAFLD patient by Crocin with low adverse effects
Design
A double blind randomized placebo-controlled trial of Crocin on patient with NAFLD.
Settings and conduct
Imam Hospital, Ahvaz
Participants/Inclusion and exclusion criteria
Inclusion criteria: both sexes, liver ultrasonography, high liver enzyme ALT and AST, >18 years old patient with NAFLD.
Exclusion criteria: Viral and autoimmune liver diseases, metabolic liver disease, drug and alcohol consumption, pharmacotherapy in NAFLD.
Intervention groups
30 patients in the group receiving Crocin tablet (Krocina 15 mg) and 30 patients receiving placebo (maltodextrin) for 8 weeks.
Main outcome variables
Treatment of NAFLD and improvement of liver enzyme and lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039634N1
Registration date:2018-06-13, 1397/03/23
Registration timing:registered_while_recruiting
Last update:2018-06-13, 1397/03/23
Update count:0
Registration date
2018-06-13, 1397/03/23
Registrant information
Name
Behnam Ghorbanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 3635
Email address
ghorbanzadeh.b@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Crocin on the serum levels of liver enzymes and Lipid Profile in patients with non-alcoholic fatty liver disease
Public title
Effect of Crocin on non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
> 18 years old
Patient with NAFLD (according to ultrasonography and high level of AST and ALT)
Exclusion criteria:
Viral and autoimmune hepatitis
Metabolic liver disease, alcohol and drug consumption
Pharmacotherapy for NAFLD
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
To maintain the double-blinded condition of the study design, labeled study medications using participant identification numbers. At the end of study, statistical analysis was performed using this data (unknown drug by statistics)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No. 33, West kianpars, Streest 20
City
Ahvaz
Province
Khouzestan
Postal code
6155893814
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.AJUMS.REC.1396.1014
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
ALT
Timepoint
Before intervention and 8 weak after intervention
Method of measurement
Enzymatic photometery
2
Description
AST
Timepoint
Before intervention and 8 weak after intervention
Method of measurement
Enzymatic photometery
3
Description
TC, TG, LDL, HDL
Timepoint
Before intervention and 8 weak after intervention
Method of measurement
Enzymatic photometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving one tablet containing 15 mg of Crocin (Samisaz Pharmaceutical Co.) daily with meal for 8 weaks.
Category
Treatment - Drugs
2
Description
Control group: receiving one tablet placebo (maltodextrin) daily with meal for 8 weaks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hospital
Full name of responsible person
Abazar Parsi
Street address
Imam Hospital, Naderi Street
City
Ahvaz
Province
Khouzestan
Postal code
6134914971
Phone
+98 61 3391 3635
Email
Ghorbanzadeh.b@dums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abazar parsi
Street address
Imam Hospital, Departement of internal medicine
City
Ahvaz
Province
Khouzestan
Postal code
6134914971
Phone
+98 61 3391 3635
Email
Ghorbanzadeh.b@dums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Abazar Parsi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
NO. 33, West kianpars, Street 20
City
Ahvaz
Province
Khouzestan
Postal code
6134914971
Phone
+98 61 3391 3635
Fax
Email
b_ghorbanzadeh82@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abazar Parsi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
NO. 33, West kianpars, Street 20
City
Ahvaz
Province
Khouzestan
Postal code
6134914971
Phone
+98 61 3391 3635
Fax
Email
b_ghorbanzadeh82@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abazar Parsi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
NO. 33, West kianpars, Street 20
City
Ahvaz
Province
Khouzestan
Postal code
6134914971
Phone
+98 61 3391 3635
Fax
Email
b_ghorbanzadeh82@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