Effects of Chlorella Vulgaris extract and Arthichoke on patients with Non-Alcoholic Fatty liver disease (NAFLD).This study has done by non blinded methods of clinical trial. Inclusion criteria and methods: 90 patients were enrolled by NAFLD(has been diagnosed with liver ultrasound and increased alanine aminotransferase (ALT) less than 5 times the normal) and without other secondary liver disease, body mass index between(25-35), then patients were randomly divided into three groups.
Intervention:30 patient as the control group only received treatment with metformin and vitamin E,the second group,30 patients were treated with Chlorella supplements and third group (30 patients), were treated with Arthichoke supplements.Patients are recommended to have daily 20 minutes of physical activity and diet 500 kcal less than the previous in a group that have BMI 30-35 and 300 kcal in BMI 25-30 as well as.
Main outcom: After eight weeks of treatment is measured serum levels of liver enzymes (ALT) and its level is considered as a measure of treatment response. (Reduced serum levels of at least 3 times as the response to treatment).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101619554N1
Registration date:2015-04-02, 1394/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-02, 1394/01/13
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Zanjan University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Chlorella Volgaris versus Arthichoke on patients with NAFLD- A randomized clinical trial
Public title
The effect of Chlorella Volgaris versus Arthichoke on patients with NAFLD- A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:
Proven fatty liver by Ultrasound, Increase liver enzyme alanine aminotransferase (ALT) between 1.5 to 5 times the normal; The mean BMI between 25-35
Exclusion criteria:
Patients with nonalcoholic steatohepatitis; Patients with systemic diseases such as diabetes - and other inflammatory diseases; Positive serology for hepatitis viral, anti-mitochondrial antibody (AMA); positive anti- nuclear antibody (ANA); TIBC increased serum iron and transferrin,TIBC, positive serum ceruloplasmin; Other secondary causes of fatty liver, Transferrin saturation more than 45.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
2
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences,Republic Street, Freedom Boulevard , opposit of Saderat Bank, Zanjan University of Medical Sciences
City
Zanjan
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
01-63-03/91
Health conditions studied
1
Description of health condition studied
Fatty liver
ICD-10 code
K75.8
ICD-10 code description
nonalcoholic steatohepatitis
Primary outcomes
1
Description
Liver Function Test
Timepoint
2m after intervention
Method of measurement
Eliza method
Secondary outcomes
1
Description
BMI(Body Mass Index)
Timepoint
2m
Method of measurement
kg/m2.
2
Description
Blood Presser
Timepoint
2m
Method of measurement
Digital manometer
3
Description
Lipid Profil
Timepoint
2month
Method of measurement
Eliza
4
Description
Blood sugar
Timepoint
2month
Method of measurement
Eliza
Intervention groups
1
Description
Intervention:30 patient as the control group only received treatment with metformin and vitamin E, The second group,30 patients were treated with Chlorella supplements and third group (30 patients),were treated with Arthichoke supplements.Patients are recommended to have daily 20 minutes of physical activity and diet 500 kcal less than the previous in a group that have BMI 30-35 and 300 kcal in BMI 25-30 as well as. Main outcom:After eight weeks of treatment is measured serum levels of liver enzymes (ALT) and its level is considered as a measure of treatment response. (Reduced serum levels of at least 3 times as the response to treatment).
Category
Treatment - Drugs
2
Description
In the control group, 30 patients receiving metformin 500 mg( is made of Eksir company) 2 times a day, after breakfast and dinner,also vitamin E 400 IU ( is made of Eksir company)once a day after lunch.Nutrition and exercise advice given to patients for 2 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital Clinic
Full name of responsible person
Maryam Jameshorani
Street address
Valiasr Hospital , Keshavarz Street,Higher than the Asr Square,Highway Sheikh Fadlallah Noori,Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Zanjan University of Medical Sciences
Full name of responsible person
Dr Faghihzade Soghrat
Street address
Vice Chancellor for Research,Zanjan University of Medical Sciences;Jomhori Street ; front of Saderat Bank
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research,Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences,
Full name of responsible person
Vice Chancellor for Research,Zanjan University of Medical Sciences,.Dr Faghihzade Soghrat
Position
Statistician
Other areas of specialty/work
Street address
Metabolic Research Center,vali Asr Hospital, Highway Sheikh Fadlallah Noori,Zanjan