The effect of Artichoke Leaf Extract on Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) in the patients with Non Alcoholic Steatohepatitis (NASH).
This study is paralled groups randomized clinical trial with a pre and post test design . The purpose of this study was to investigate the effects of Artichoke Leaf Extract on Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) in the patients with Non Alcoholic Steatohepatitis (NASH).NASH patients were recruited from Gastroenterogy and hepatology clinic of shahid Dr. chamran hospital in Tehran,iran in regard to inclusion and Exclusion criteria . To be included patients needed to have: (1) Abnormal serum transaminases ≥ 30 U/L (2) Fatty liver in ultrasonography . With these criteria 60 subjects considered in this study.consent obtained from each patient.they could quit the study freely. The subjects were randomly assigned in two grups ; intervention and placebo groups. Intervention group received 6 Cynarckol tablets daily after each meal (2 tablets after break fast ,2 tablets after lunch and 2 tablets after dinner) containing 2700 mg Artichoke Leaf Extract for 8 weeks and placebo group received 2700 mg placebo daily in 6 placebo tablets (2 tablets after break fast ,2 tablets after lunch and 2 tablets after dinner) for 8 weeks. Both groups receive diet and physical activity advice during the study. Diet , exercise and medical dosage were held constant throughout the study. In both groups Alanine aminotransferase (ALT) , Aspartate aminotrans (AST) , Fasting blood glucose, Total Cholesterol,LDL Cholesterol ,HDL Cholesterol ,triglyceride levels were measured at the baseline and will measure at the end of intervention. the results will be compare in two groups by statistical analyses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070218321N1
Registration date:2014-08-04, 1393/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Vajiheh Rangboo
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
vrangboo@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences, Faculty of Health
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Artichoke Leaf Extract on Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) in the patients with Non Alcoholic Steatohepatitis (NASH).
Public title
The effect of Artichoke Leaf Extract in the patients with Non Alcoholic Steatohepatitis (NASH).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Abnormal serum transaminases ≥ 30 U/L ; Fatty liver in ultrasonography; At least one of the following, FBS greater than 100 mg/dL or a previous diagnosis of type II diabetes,obesity ( Body mass index of 30 or higher ),Blood pressure greater than 130/85 ,Triglyceride-levels greater than 150 mg/dl ,HDL-cholesterol lower than 40 mg/dl (men) and 50 mg/dl (women) ,Total cholesterol greater than 200 mg/dl.
Exclusion criteria:Daily alcohol consumption;Type I diabetes;Concomitant liver diseases,Presence of HCV antibody or HBs antigen, auto-immune hepatitis, hemochromatosis, Wilson’s disease, alpha1 anti-trypsin deficiency, Biliary obstruction;Use of livergol,Vit E, Vit C,UDCA,Heptotoxic Drug;Treatment with a drug known to induce NASH (amiodarone,calcium channel blocker, tamoxifen), and oral anticoagulation;Decompensated cirrhosis;Serious disease limiting life expectancy;Pregnancy and lactation;people who are Allergy sensitive to the Asteraceae/Compositae family.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
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
Qazvin University of Medical Sciences
Street address
Qazvin,Bahonar bolvar, Pardis, Qazvin University of Medical Sciences
City
qazvin
Postal code
59811-34197
Approval date
2013-10-09, 1392/07/17
Ethics committee reference number
28/20/7929
Health conditions studied
1
Description of health condition studied
non alcoholic steatohepatitis
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
alanine aminotransferase (ALT)
Timepoint
before and after intervention
Method of measurement
IU/Lit
2
Description
aspartate aminotransferas (AST)
Timepoint
before and after intervention
Method of measurement
IU/Lit
Secondary outcomes
1
Description
total cholestrol
Timepoint
before and after the intervention
Method of measurement
Mg/dL
2
Description
LDL-C
Timepoint
before and after the intervention
Method of measurement
Mg/dL
3
Description
HDL-C
Timepoint
before and after the intervention
Method of measurement
Mg/dL
4
Description
Triglycerid
Timepoint
before and after the intervention
Method of measurement
Mg/dL
5
Description
fasting blood sugar
Timepoint
before and after the intervention
Method of measurement
Mg/dL
Intervention groups
1
Description
placebo group received 6 placebo tablets daily (2 tablets after break fast ,2 tablets after lunch and 2 tablets after dinner) for 8 weeks.
Category
Placebo
2
Description
Intervention group received 6 Cynarckol tablets daily, containing 2700 mg Artichoke Leaf Extract after each meal (2 tablets after break fast ,2 tablets after lunch and 2 tablets after dinner) for 8 weeks.