This study was designed as a double-blind randomized controlled trial on 100 Non-Alcoholic Fatty Liver patients. At start of study the patient of both groups evaluated for demographic variables, past medical history, age, height, BMI, duration of exercise per day, and diet. Adults (age > 18 y) with a diagnosis of Fatty Liver disease and a negative history of Hypersensitivity to Curcumin and Turmeric were recruited to the trial. Subjects with biliary diseases, Statin-treated Hyperlipidemia, pregnancy and lactation were excluded from the trial. Participants were randomized to Curcumin (1000 mg/day in two divided doses) and control groups and were treated for a period of 8 weeks. Response to treatment was evaluated using liver Doppler sonography at baseline and at the end of study. Determination of serum levels of hepatic transaminases, total and direct bilirubin, uric acid, lipids and glucose was also performed both at the start and end of the trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122525641N2
Registration date:2016-01-16, 1394/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-16, 1394/10/26
Registrant information
Name
Parisa Kianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2660 2854
Email address
pk.pioneer1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Baqiyatallah University of Medical Science
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-25, 1394/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin in treatment of Non-Alcoholic Fatty Liver Disease: A Randomized Double-blind Clinical Trial Including Placebo
Public title
The efficacy of Curcumin in treatment of Non-Alcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient has Fatty Liver; The history of allergic reaction to the drug combination is not relevant; Over 18 years old; The patient has informed consent to participate in the study;
Exclusion criteria:
The patient who stops the medication more than 1 week; The patient with the history of biliary disease; The patient with Fatty Liver, who also has Hyperlipidemia and receives statins; Patient with Fatty Liver, who also has another liver disease; Pregnancy and lactation; The patient who expresses uncontrolled adverse effects by this drug; alcohol consumption and any addictive drugs.
Age
From 18 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
It is a double-blind clinical trail in which neither patients nor analysis technician have no information about the kind of pharmacotherapy(drug or placebo) were received by patients.
The Curcumin capsule was manufactured at Aburaihan Pharma Company.
The Curcumin capsules are the extract of Turmeric, each capsule contains 500 mg Curcumin.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, Mollasadra St., Vanak
City
Tehran
Postal code
Approval date
2014-06-08, 1393/03/18
Ethics committee reference number
s/340/221
Health conditions studied
1
Description of health condition studied
Fatty Liver
ICD-10 code
k76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
The accumulation of liver fat
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Color Doppler Ultrasonography
Secondary outcomes
1
Description
Portal vein diameter
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Color Doppler Ultrasonography
2
Description
Hepatic blood flow velocity
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Color Doppler Ultrasonography
3
Description
AST
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
4
Description
ALT
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
5
Description
HDL
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
6
Description
Total Cholesetrol
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
7
Description
LDL
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
8
Description
TG
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
9
Description
Uric Acid
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
10
Description
FBS
Timepoint
Before the intervention, 8 weeks later at the end of the intervention
Method of measurement
Blood test
11
Description
HbA1C
Timepoint
Before the intervention,8 weeks later at the end of the intervention
Method of measurement
Blood test
Intervention groups
1
Description
Curcumin, 500 mg oral Capsule,2 times a day for 8 weeks
Category
Treatment - Drugs
2
Description
Placebo, 500mg oral capsule, twice a day for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Mohtashami Reza(internist)
Street address
Baqiyatallah hospital, Mollasadra Ave., Vanak
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Baqiyatallah University of Medical Science
Full name of responsible person
Ahmadi Morteza(The Deputy Director of Research and Technology of Baqiyatallah University of Medical
Street address
Baqiyatallah University of Medical Science, South Sheikhbahaee St. , Mollasadra Ave., Vanak
City
Tehran
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 of Baqiyatallah University of Medical Science
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
Islamic Azad University of Pharmaceutical Science
Full name of responsible person
Kianpour Parisa
Position
Pharm.D student
Other areas of specialty/work
Street address
Islamic Azad University of Pharmaceutical Science, Yakhchal St., Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
pk.pioneer1@yahoo.compkp.pioneer1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Science
Full name of responsible person
Panahi Yunes
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, South Sheikhbahaee St. , Mollasadra Ave., Vanak