The Effect of curcumin on oxidative indices, inflammatory factors and Sequential Organ Failure Assessment Score in patients with systemic inflammatory response syndrome
1- Determination and comparison of curcumin supplement effects on oxidative indices (MDA, TAC) in supplement curcumin receiving group and control group in Patients with SIRS.
2-Determination and comparison of curcumin supplement effects on inflammatory indices (TNF-α, IL-6) in supplement curcumin receiving group and control group in Patients with SIRS.
3- Determination and comparison of curcumin supplement effects on SOFA index in supplement curcumin receiving group and control group in patients with SIRS.
Design
In this study 40 patients aged 18-50 years with systemic inflammatory response syndrome (SIRS positive) are select in ICU.In the ICU Patients
who eligible for inclusion criteria were diagnosed (based on the APACHEII score on the first day for homogenization of patients), the samples collect from these patients. Participants are randomly assigned to RAS software by random block method in one of two groups of curcumin or control group. Each participant is being assigned a code.
Settings and conduct
After selecting samples from Imam Reza Hospital in Tabriz, pateints were randomly assigned to one of the two supplement curcumin and control groups. The Intervention group (two 80 mg capsules) will receive 160 mg / day curcumin at least 1 hour interval with the received fluids, and the control group will receive the usual formulation without supplementation. On the first day and on the 10th day of the study, the SOFA questionnaire will complete the nutritional status of the patients. To determine the nutritional status of patients, the new formulas will be used to indirectly measure height and weight (using Ulna Length) and the middle of the arm and the body index (BMI) will be calculated after determining the height and weight.Also, the amount of energy intake and macro nutrients will be calculated by measuring the received form of each patient during the study period. The patient's formula will be designed after measurement and calculations (based on height, weight, physiological status and type of disease, surgery) and on how to prepare, quantity and time of use will be monitored.The combinesin of patients Formula will be different according to their nutritional requirements and will be considered as a confounding factor in the evaluation and statistical analysis. The APACHEII questionnaire will also be completed at the beginning of the study for each patient. Also, on the first day and on the tenth day, the study will be as much as 5 cc Blood samples were taken from patients to determine and compare the effects of curcumin supplementation between the two groups receiving the complement of curcumin and the control group on the levels of inflammatory factors, oxidative indices and SOFA and will be evaluated and verified according to the instructions.
Participants/Inclusion and exclusion criteria
Inclusions criteria for the study:
Critically ill ICU patients with APACHE II score of 15-30;
Positive SIRS;
Aged over 18 and under the age of 60 years;
Hospitalization at least 10 days in ICU;
Recipients of enteral nutrition formula;
Exclusions criteria:
Parenteral feeding;
Intolerance to enteral feeding and gavage solution;
Patient is waiting for death in the 24 future hourse;
HIV positive patient;
Pregnant and lactating women;
Ileus;
Mellitus diabetes;
Short bowel syndrome;
Pancreatitis;
Immune disorders
Intervention groups
The intervention group (two 80 mg capsules) will receive 160 mg / day curcumin at least 1 hour interval with the received fluids, and the control group will receive the usual formulation without supplementation.
The control group will receive the usual formulation without supplementation. Which include carbohydrates and calories in patients with serum containing dextrose (1.3 and 3.2 and D5W)
Main outcome variables
1- Assessment of oxidative indices (MDA, TAC)
2- Assessment of inflammatory factors (TNF-α, IL-6)
3. Assessment of SOFA index
4. Assessment of nutrition status
General information
Reason for update
Acronym
coiss
IRCT registration information
IRCT registration number:IRCT20110123005670N7
Registration date:2017-12-15, 1396/09/24
Registration timing:prospective
Last update:2017-12-15, 1396/09/24
Update count:1
Registration date
2017-12-15, 1396/09/24
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of curcumin on oxidative indices, inflammatory factors and Sequential Organ Failure Assessment Score in patients with systemic inflammatory response syndrome
Public title
The Effect of curcumin on patients with systemic inflammatory response syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill ICU patients with APACHE II score of 15-30;
Positive SIRS;
Aged over 18 and under the age of 60 years;
Hospitalization at least 10 days in ICU;
Recipients of enteral nutrition formula
Exclusion criteria:
Parenteral feeding;
Intolerance to enteral feeding and gavage solution;
Patient is waiting for death in the 24 future hourse;
HIV positive patient;
pregnant and lactating women;
Ileus;
Mellitus diabetes;
Short bowel syndrome;
Pancreatitis;
Immune disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
With Using of RAS software in two groups of 20 people
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.TBZMED.REC.1396.762
Health conditions studied
1
Description of health condition studied
Sepsis/At risk of sepsis
ICD-10 code
R65.1
ICD-10 code description
Systemic inflammatory response syndrome (SIRS) of non-infectious origin
Primary outcomes
1
Description
Inflammation
Timepoint
First day and tenth day
Method of measurement
Interleukin 6 and tumor necrosis factor alpha
2
Description
Oxidative stress
Timepoint
First day and tenth day
Method of measurement
Total antioxidant capacity and malondialdehyde
3
Description
Sequential Organ Failure Assessment (SOFA)
Timepoint
First day and tenth day
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Nutrition status
Timepoint
First day and tenth day
Method of measurement
Received calorie measuring
Intervention groups
1
Description
Intervention group: Two curcumin capsules(Sina Pharmaceutical Company) of 80 mg per day for ten days
Category
Treatment - Drugs
2
Description
Control group: Common formulas
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Ata Mahmodpour
Street address
Golgasht Street
City
tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 7056
Email
amahmoodpoor@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Golgasht street, Tabriz University Of Medical Science, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
tarighata@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Dean for Research and Technology Tabriz University Of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ali Tarighat-Esfanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
TABRIZ
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tarighat esfanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arash Karimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 300 5895
Email
karimi.ara1990@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available