The herbal tea of Artichoke has a therapeutic effect on fatty liver disease.
Design
This study was done to investigate the effect of drinking of Cynara scolymus L. (Artichoke) herbal tea on the levels of AST, ALT and liver parenchyma echogenicity of 60 patients (40 women and 20 men), aged from 25 to 63 years old in Hamedan city, Iran. The blood enzymes assay and liver sonography were performed after clinical diagnosis and after treatment. Studied people were divided based on the ultrasound criterion for fatty liver disease as follows: mild (5 patients) as grade1, moderate (8 patients) as grade2 and severe (2 patients) as grade3
Settings and conduct
Hamedan Imam Khomeini Clinic.
In this study, blindness has not been performed and this study is done based on the pre-medicine and post-medicine method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30-65 years old; Detection of Non-alcoholic Fatty Liver based on high levels of ALT and AST enzymes. Ultrasound diagnosis of Fatty Liver. BMI was more than 25. People who did not Use Antioxidant complementary during a month before sampling. People who had not underlying diseases like heart acute disease, kidney, infections, diabetes, hepatitis B or C and other diseases of the liver. Not having a severe weight losing or gaining regimens within 3 months before sampling. No using of effective drugs on weight during 3 months prior to sampling. Not using drugs that are likely to be related to this disease (methotrexate, amiodarone, tamoxifen, corticosteroids, valproic acid). Exclusion criteria: Pregnancy and lactation; alcohol drinking; other liver diseases; Diet or treatment for fatty liver in the last 3 months; autoimmune diseases and cancer Reluctance to continue research.
Intervention groups
Chopped leaves of dried Artichoke- it is used twice a day (fasting in the morning and at night before bedtime) for 45 days. Brewing a tablespoon of leaf with a boiling cup (like tea) for 20 minutes on an indirect heat at 80 °C.
Main outcome variables
Liver enzymes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130126012278N3
Registration date:2018-02-21, 1396/12/02
Registration timing:retrospective
Last update:2018-02-21, 1396/12/02
Update count:0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
Mosen Rajabi
Name of organization / entity
Applied Scientific University of Jihad-Agriculture
Country
Iran (Islamic Republic of)
Phone
+98 81 3437 3587
Email address
m.rajabi@areo.ir
Recruitment status
Recruitment complete
Funding source
Hamedan Agricultural and Natural Resources Research and Education Center
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-08-23, 1396/06/01
Trial completion date
empty
Scientific title
The effect of Cynara scolymus L.on fatty liver indices
Public title
The effect of Artichoke on fatty liver indices
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30-65 years old
Detection of Non-alcoholic Fatty Liver based on high levels of ALT and AST enzymes
Ultrasound diagnosis of Fatty Liver
BMI was more than 25
People who did not Use Antioxidant complementary during a month before sampling
People who had not underlying diseases like heart acute disease, kidney, infections, diabetes, hepatitis B or C and other diseases of the liver
Not having a severe weight losing or gaining regimens within 3 months before sampling
Not using of effective drugs on weight during 3 months prior to sampling
Not using drugs that are likely to be related to this disease (methotrexate, amiodarone, tamoxifen, corticosteroids, valproic acid)
Exclusion criteria:
Pregnancy and lactation
Alcohol drinking
other liver diseases
Diet or treatment for fatty liver in the last 3 months
Autoimmune diseases and cancer
Reluctance to continue research
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Science
Street address
Shahid Fahmideh Street, Hamedan University of Medical Science,
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2014-12-24, 1393/10/03
Ethics committee reference number
16/35/9/4785/پ
Health conditions studied
1
Description of health condition studied
Non alcoholic Fatty Liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Liver enzymes
Timepoint
At the beginning of study, 48 hours after the end of the study (this study will take 7 weeks).
Method of measurement
blood assay results (including AST and ALT)
Secondary outcomes
1
Description
The amount of liver fat accumulation.
Timepoint
45 days
Method of measurement
Doppler color ultrasound
2
Description
Liver Enzymes
Timepoint
45 days
Method of measurement
Blood examination Results
Intervention groups
1
Description
Chopped leaves of dried Artichoke- it is used twice a day (fasting in the morning and at night before bedtime) for 45 days. Brewing a tablespoon of leaf with a boiling cup (like tea) for 20 minutes on an indirect heat at 80 °C.