According to studies on the effects of low health effects and side effects of Curcumin in treating non-alcoholic fatty liver disease in humans, the research done in this field in order to understand the mechanisms of effective dose estimates and impact it seems essential.
A total of 60 patients will randomly divide into two groups of 30 and for two months to a 30-Member group of Curcumin, Curcumin will be prescribe to the amount of 80 mg 2 times a day and to the Placebo group, placebo will be prescribe to the group of 30. 2 months after applying the intervention, patients will be evaluate by and compare in laboratory and clinical criteria.
Inclusion criteria:
1. having ALT and AST upper than highest normal level
2.the age of 15 to 60
Exclusion criteria:
1. Alcohol consumption
2. Get a positive serology of viral hepatitis
Primary outcome measures are:ALT- AST; ALP; TG; Total Cholesterol; HDL; LDL; FGS; Serum Insulin; Total Bilirubin; Direct Bilirubin
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012031423N1
Registration date:2017-05-22, 1396/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-22, 1396/03/01
Registrant information
Name
Hosein Rajablou
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3588 2645
Email address
rajablouh901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Financial sources are supplying from Vice chancellor for research, Mashhad University of Medical Sciences.
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of influence of Curcumin on non-invasive liver marker`s in patients with nonalcoholic fatty liver disease
Public title
The influence of Curcumin on Non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. having ALT and AST upper than highest normal level
2. have at least one of the following:
A) Diabetes
B) Hyperlipidemia
C) Obesity
3. The age of 15 to 60
Exclusion criteria:
1. Alcohol consumption
2. Get a positive serology of viral hepatitis
3. ANA or AMA positive test, Alpha1 Antitrypsin, Low serum levels of Seroloplasin or high levels of antibodies of ASMA or LKM.
4. High ferritin 450 or Iron/TIBC> 45%
5. The patient before the intervention or during the intervention, affected with acute or chronic disease that causes in LFT disorders.
6.The patient before the intervention or during the intervention is consuming medicine that potentially capable of Disrupting the LFT.
7. Pregnancy
8. Patients Younger than 15 or older than 60.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
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
Sealed envelopes
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad university of medical sciences
Street address
University street, Ghoreishi building, Vice Chancellor of Research Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2016-12-13, 1395/09/23
Ethics committee reference number
IR.MUMS.fm.REC.1394.690
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
BMI
Timepoint
Before and two months after intervention
Method of measurement
Measuring the weight by Scale and height by Metre
2
Description
ALT
Timepoint
Before and two months after intervention
Method of measurement
Serology
3
Description
AST
Timepoint
Before and two months after intervention
Method of measurement
Serology
4
Description
ALP
Timepoint
Before and two months after intervention
Method of measurement
Serology
5
Description
TG
Timepoint
Before and two months after intervention
Method of measurement
Serology
6
Description
Total Cholestrol
Timepoint
Before and two months after intervention
Method of measurement
Serology
7
Description
HDL
Timepoint
Before and two months after intervention
Method of measurement
Serology
8
Description
FBS
Timepoint
Before and two months after intervention
Method of measurement
Serology
9
Description
Serum Insulin
Timepoint
Before and two months after intervention
Method of measurement
Serology
10
Description
LDL
Timepoint
Before and two months after intervention
Method of measurement
Serology
11
Description
Total Bilirubin
Timepoint
Before and two months after intervention
Method of measurement
Serology
12
Description
Direct Bilirubin
Timepoint
Before and two months after intervention
Method of measurement
Serology
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in groups of 30 for a period of two months Placebo 2 times a day will be prescribed
Category
Placebo
2
Description
Intervention group: Patients in groups of 30 for a period of two months curcumin(Sinacurcumin; nanomicelles) to 80 mg 2 times a day will be prescribed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital subspecialty clinics
Full name of responsible person
DR Beheshti Namdar, Ali(Gastroenterologist; Assistant Professor)
Street address
Ghaem hospital; Ahmad abad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
DR tafaghodi, Mohsen
Street address
University street, Ghoreishi building, Vice Chancellor of Research Mashhad University of Medical Sciences
City
Mashhad
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 Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
DR Beheshti Namdar, Ali
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaem hospital; Ahmad abad
City
Mashhad
Postal code
Phone
+98 51 3843 4637
Fax
Email
beheshtia@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Universty of medical Sciences
Full name of responsible person
DR Beheshti Namdar, Ali
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaem Hospital; Ahmad abad
City
Mashhad
Postal code
Phone
+98 51 3843 4637
Fax
Email
beheshtia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Uedical Sciences
Full name of responsible person
Rajablou, Hosein
Position
Medical Intern
Other areas of specialty/work
Street address
Shahid bahonar Blv; Vakil abad
City
Mashhad
Postal code
Phone
00
Fax
Email
rajabloo.hosein@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)