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Effect of curcumin on coagulation factors, anti-inflammatory factor and Simplified Acute Physiology Score ॥ in patients with systemic inflammatory response syndrome

Protocol summary

Study aim
Determination and comparison of the effect of curcumin supplementation on coagulation factors (Protein C, PTT), anti-inflammatory factor (TGF-β1) and simplified acute physiology score II (SAPS II) in the curcumin supplement group and control group in patients with systemic inflammatory response syndrome (SIRS)
Design
The present study is a randomized, single blinded clinical trial of 32 patients aged 18-60 years with SIRS in ICU.Samples were randomly assigned to RAS software in one of two groups of curcumin supplementation and control.
Settings and conduct
After selecting samples from Imam Reza Hospital in Tabriz, patients are placed in one of the two groups of curcumin supplement and control. During the intervention on the first, fifth and tenth day of the study, the SAPSII questionnaire will be completed and 5cc blood will be taken from patients to examine the factors.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Critically ill patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 15-30, Positive Systemic inflammatory response syndrome (SIRS), Age over 18 and under 60, At least 10 days hospitalization in ICU, Patients who received enteral nutrition formula Exclusion criteria: Parenteral feeding, Enteral nutrition and gavage formula intolerance, Patients expected to die within the next 24 hours, HIV positive, Pregnancy and lactation, ileus, Immune disorder, Diabetes melitus, Short bowel syndrome, Pancreatitis
Intervention groups
The intervention group will receive (two 80-mg capsules), 160 miligram per day curcumin, at least 1 hour away from the patient's formula (to avoid possible food-drug interactions) with the received fluids, and the control group will receive the usual formula without supplementation.
Main outcome variables
Assessment of coagulation factors (Protein C, PTT), anti-inflammatory factor (TGF-β1), and SAPSII

General information

Reason for update
Acronym
cosirs
IRCT registration information
IRCT registration number: IRCT20110123005670N27
Registration date: 2019-02-24, 1397/12/05
Registration timing: registered_while_recruiting

Last update: 2019-02-24, 1397/12/05
Update count: 0
Registration date
2019-02-24, 1397/12/05
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
2018-12-26, 1397/10/05
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin on coagulation factors, anti-inflammatory factor and Simplified Acute Physiology Score ॥ in patients with systemic inflammatory response syndrome
Public title
Effect of curcumin on systemic inflammatory response syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill patients with APACHE II score of 15-30 Positive SIRS Age over 18 and under 60 At least 10 days hospitalization in ICU Patients who received enteral nutrition formula
Exclusion criteria:
Parenteral feeding Enteral nutrition and gavage formula intolerance Patients expected to die within the next 24 hours HIV positive patients Pregnant and lactating women ileus Immune disorder Diabetes melitus Short bowel syndrome Pancreatitis
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using RAS software and random block method
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in this study will not be aware of the supplementation of curcumin due to low alertness
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
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-12-24, 1397/10/03
Ethics committee reference number
IR.TBZMED.REC.1397.762

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
Protein C
Timepoint
Day 1, 5 and 10 of intervention
Method of measurement
ELISA Kit

2

Description
Partial Thromboplastin time
Timepoint
Day 1, 5 and 10 of intervention
Method of measurement
ELISA kit

3

Description
Prediction of death
Timepoint
Day 1, 5 and 10 of intervention
Method of measurement
Simplified Acute Physiology Score questionnaire

4

Description
Transforming growth factor β1
Timepoint
Day 1, 5 and 10 of intervention
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Two 80-mg capsules of nano-curcumin (Sina Pharmaceutical Company) per day for 10 days
Category
Treatment - Drugs

2

Description
Control group: entera meal formula (karen company) or blenderized formula (contain rice flour and meat or poultry and tomato or carrot or cucumber and olive oil or corn oil and apple or orange and yoghurt or powdered milk)
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
Deputy of Research and Technology of Tabriz University of Medical Sciences
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
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, Ghol-Ghasht st,Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7581
Fax
Email
tarighata@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Tarighat Esfanjani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, Ghol-Ghasht st,Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7581
Fax
Email
tarighata@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Zarei
Position
Master Of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neishbaouri st, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 300 5895
Email
elhamzarei7226@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
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