Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines and highly sensitive C-reactive protein level in the patients with fatty liver (Double blind RCT)
The aim of this study is evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines and highly sensitive C-reactive protein (hsCRP) level in the patients with non- alcoholic fatty liver. Study is designed as Randomized, double-blind trial. Examples include patients referred to Clinic of 22 Bahaman Hospital in Neyshabur city that disease has been confirmed by ultrasound examination and liver enzyme levels. 120 patients (age 15-60) are selected and will be divided into two groups. Exclusion criteria are included: enhancing drugs liver enzymes; malabsorption syndrome; steroid use; heart and lung disease; regnant and lactating women; diabetic patients; triglycerides over 150mg/dl; hypothyroidism and hyperthyroidism; hepatitis B and C; Wilson's disease; celiac disease; deficiency of alpha-1 antitrypsin and alcohol consumption. Intervention with different doses and formulation of curcumin capsules are done for 60 days. Patients are randomly divided into three equal groups.
Group 1: Placebo; Lactose capsules at a dose of 500 mg / day (n = 40)
Group 2: Intervention with dose of 250 mg / day (n = 40)
Group 3: Intervention with 500 mg / day (n = 40)
At the beginning and end of the study, blood levels of the 12 inflammatory cytokines and hsCRP will be evaluated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052322381N1
Registration date:2016-09-17, 1395/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-09-17, 1395/06/27
Registrant information
Name
Azam Rezaei Farimani
Name of organization / entity
Neyshabur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4334 4011
Email address
rezaia1@nums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neyshabur University of Medical Sciences (research grants)
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines and highly sensitive C-reactive protein level in the patients with fatty liver (Double blind RCT)
Public title
Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines & highly sensitive C-reactive protein
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include:
Age 15 to 60 years; rejection of causes that increase hepatic transaminases such as viral infections; autoimmune liver disease; poisons and toxins; Radiology approval of fatty liver.
Exclusion criteria included:
Medication that increase liver enzymes; malabsorption syndrome; corticosteroids drugs; Heart and pulmonary disease; Lactating and pregnant women; Age above 60 years and below 15 years; diabetic patients; People with hypothyroidism and hyperthyroidism; triglycerides more than 150mg/dL; B and C hepatitis; Wilson disease; Hemochromatosis; Celiac and alpha-1 antitrypsin deficiency; alcohol consumption
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
43
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
Ethics Committee of the Neyshabur University Of Medical Sciences
Street address
Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabur
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.NUMS.REC.1394.18
Health conditions studied
1
Description of health condition studied
NAFLD
ICD-10 code
K75.8
ICD-10 code description
nonalcoholic steatohepatitis
Primary outcomes
1
Description
MCP-1
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
2
Description
VEGF
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
3
Description
IL-1α
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
4
Description
IL-1β
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
5
Description
IL-2
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
6
Description
IL-4
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
7
Description
IL-6
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
8
Description
IL-8
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
9
Description
IL-10
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
10
Description
TNF-α
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
11
Description
INFγ
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
12
Description
EGF
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
13
Description
hsCRP
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
Secondary outcomes
1
Description
Liver enzymes
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
2
Description
Levels of serum lipid profile
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
3
Description
Serum levels of fasting blood glucose
Timepoint
Before intervention and three months after the end of intervention
Method of measurement
Examining blood samples
Intervention groups
1
Description
Intervention groups: Capsules containing curcumin with two doses and two different formulations; 250 mg / day (phytosomal curcuminoids) and 500 mg/day (curcuminoids plus piperine) for 60 days
Category
Treatment - Drugs
2
Description
Control group:
placebo, starch, 80 mg capsules، single dose per day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Dr.Elham Mokhtari
Street address
Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabur
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Neyshabur University of Medical Sciences
Full name of responsible person
Dr. Abasalt Borji
Street address
Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabur
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, Neyshabur 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
Neyshabur University of Medical Sciences
Full name of responsible person
Elham Hooshmand
Position
Educator
Other areas of specialty/work
Street address
Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabur
Postal code
Phone
+98 51 4334 4011
Fax
+98 43333964
Email
hooshmand.elham67@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
Dr.Seyed Reza Mirhafz
Position
Assistant Professor
Other areas of specialty/work
Street address
Office of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabur
Postal code
Phone
+98 51 4334 4011
Fax
+98 43333964
Email
Mirhafezr@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neyshabur University of Medical Sciences
Full name of responsible person
Dr.Azam Rezaei Farimani
Position
Assistant Professor
Other areas of specialty/work
Street address
IOffice of Research Affairs, Razi St, Shahid Jafari St, Imam Khomeini Square, Neyshabur, Iran
City
Neyshabur
Postal code
Phone
+98 936 697 3022
Fax
+98 43333964
Email
azam_rezaei1@yahoo.com؛ rezaia1@nums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)