(1)Objectives : The aim of this study is to analyse effects of Cichorium intybus seed on liver enzyme, body composition and sonographic findings in patients with Non-Alcoholic Fatty Liver Disease.(2) Design: randomized, double blind trial study.(3) Setting and conduct: 60 patients suffering from fatty liver disease will be selected among patients referring to Endocrinology and Metabolism Research Center in Zanjan , and will be assigned into intervention and control group. (4) Participants: inclusion criteria: sign the consent form؛ age between 20-45 years؛ BMI between 25-35؛Ultrasound evidence confirm fatty liver disease؛ ALT level: more than 60 for men and 38 for women؛ negative pregnancy test؛ No breastfeeding؛ No alcohol consumption؛ non diabetes , kidney disease(Cr more than 1.5), hypothyroidism، hyperthyroidism، acute and chronic liver diseases، malignancy؛ non hepatotoxic drug consumption since 6 months ago؛ no allergy to Cichorium intybus. Exclusion Criteria: positive pregnancy test؛
allergy to Cichorium intybus؛ no tendency to continue the program. (5) Intervention: Consumption of Cichorium intybus seed syrup,8 cc bid and in control group Consumption of 8 cc bid placebo for one month (6)main outcome measures: at the beginning and end of the study, blood levels of alanin aminotranspherase and aspartat aminotranspherase, FBS,LDL,HDL,body composition and ultrasonography will be taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061228411N1
Registration date:2017-05-31, 1396/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Maral Marzban
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 4771
Email address
maralmarzban@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice chancellor of Zanjan University of Medical Science
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Cichorium intybus seed on treatment of nonalcoholic fatty liver disease,a randomized double_blind clinical trial
Public title
Effect of Cichorium Intybus seed on treatment of nonalcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: sign the consent form؛ age between 20-45 years؛ BMI between 25-35؛Ultrasound evidence confirm fatty liver disease؛ ALT level: more than 60 for men and 38 for women؛ negative pregnancy test؛ No breastfeeding؛ No alcohol consumption؛ non diabetes , kidney disease(Cr more than 1.5), hypothyroidism، hyperthyroidism، acute and chronic liver diseases، malignancy؛ non hepatotoxic drug consumption since 6 months ago؛ no allergy to Cichorium intybus. Exclusion Criteria: positive pregnancy test؛
allergy to Cichorium intybus؛ no tendency to continue the program.
Age
From 20 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of zanjan medical university
Street address
Zanjan University of Medical Sciences- Azadi square- Zanjan
City
Zanjan
Postal code
00982433567401
Approval date
2016-11-05, 1395/08/15
Ethics committee reference number
195.ZUMS.REC.1395
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, 1 and 2 months after intervention
Method of measurement
photometric
2
Description
AST
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
photometric
3
Description
FBS
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
Fasting blood glucose concentrations
4
Description
Triglisirid
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
blood test
5
Description
Cholestrol
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
blood test
6
Description
LDL
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
blood test
7
Description
HDL
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
blood test
8
Description
BMI
Timepoint
before intervention, 1 and 2 months after intervention
Method of measurement
weight with kilograms on a scale,height with meters with the use of a rubber meter
9
Description
The severity of fatty liver
Timepoint
before intervention, 1 and 2 months after intervention