Protocol summary
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Study aim
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1- Determining and comparing the effect of curcumin supplementation on oxidative indices in patients with systemic inflammatory response syndrome (SIRS).
2- Determining and comparing the effect of curcumin supplementation on inflammatory indicators in patients with SIRS.
3- Determining and comparing the effect of curcumin supplementation on the SOFA index in patients with SIRS
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Design
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In this study 40 patients aged 18-50 years with systemic inflammatory response syndrome (SIRS positive) are selected in ICU Participants are randomly assigned to RAS software by random block method in one of two groups of curcumin or a control group.
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Settings and conduct
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After selecting the samples from Imam Reza Tabriz Hospital, the patients are placed in one of two curcumin and control groups. On the first, fifth and tenth day of the study,the SOFA questionnaire, nutritional status will be completed for the patients.Also, 5 cc of blood will be taken from the patients
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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The intervention group (two 80 mg capsules) will receive 160 mg / day curcumin
The control group will receive the usual formulation without supplementation.
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Main outcome variables
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1- Assessment of oxidative indices
2- Assessment of inflammatory factors
3. Assessment of SOFA index
4. Assessment of nutrition status
5. Assessment of biochemical factors
General information
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Reason for update
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Publishing some of the study results and updating the modified factors related to the disease
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Acronym
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coiss
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IRCT registration information
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IRCT registration number:
IRCT20110123005670N7
Registration date:
2017-12-15, 1396/09/24
Registration timing:
prospective
Last update:
2023-08-21, 1402/05/30
Update count:
1
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Registration date
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2017-12-15, 1396/09/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-22, 1396/10/01
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Expected recruitment end date
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2018-07-23, 1397/05/01
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Actual recruitment start date
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2018-11-19, 1397/08/28
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Actual recruitment end date
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2019-08-27, 1398/06/05
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Trial completion date
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2019-08-27, 1398/06/05
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Scientific title
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The Effect of curcumin on oxidative indices, inflammatory factors and Sequential Organ Failure Assessment Score in patients with systemic inflammatory response syndrome
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Public title
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The Effect of curcumin on patients with systemic inflammatory response syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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With Using of RAS software in two groups of 20 people
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-11-13, 1396/08/22
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Ethics committee reference number
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IR.TBZMED.REC.1396.762
Health conditions studied
1
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Description of health condition studied
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Sepsis/At risk of sepsis
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ICD-10 code
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R65.1
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ICD-10 code description
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Systemic inflammatory response syndrome (SIRS) of non-infectious origin
Primary outcomes
1
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Description
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Inflammation
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Timepoint
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First, fifth, and tenth day
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Method of measurement
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Interleukin 6 and tumor necrosis factor-alpha, Forkhead box P3, NLR family pyrin domain containing 3, interferon-gamma, and nuclear factor kappa B, high mobility group box 1, Interleukin 8 ,Interleukin 17 and Interleukin 22, Interleukin 10, presepsin, TLR4, ICAM- 1, VCAM-1and PCT
2
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Description
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Oxidative stress
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Timepoint
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First, fifth, and tenth day
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Method of measurement
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Total antioxidant capacity and malondialdehyde, Nrf2,SOD, GPX, BAX, BCL2
3
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Description
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Sequential Organ Failure Assessment (SOFA)
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Timepoint
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First, fifth, and tenth day
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Nutrition status
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Timepoint
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روز1، 5و روز 10
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Method of measurement
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Received calorie measuring
2
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Description
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Biochemical factors
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Timepoint
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روز1، 5و روز 10
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Method of measurement
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Biochemistry kit
Intervention groups
1
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Description
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Intervention group: Two curcumin capsules(Sina Pharmaceutical Company) of 80 mg per day for ten days
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Category
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Treatment - Drugs
2
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Description
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Control group: Common formulas
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Vice-Dean for Research and Technology Tabriz University Of Medical Science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2023-08-21, 1402/05/30
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2020-04-28, 1399/02/09
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Abstract of published paper
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Introduction
Sepsis is a severe reaction and excessive immune response to infection, which can lead to tissue damage, organ dysfunction, and death. This study aimed to investigate the protective effect of curcumin on inflammatory factors and clinical outcomes in patients with sepsis.
Methods
This randomized clinical trial was conducted on 40 patients with sepsis aged 18–55 years, who received 160 mg of nano curcumin supplement (two capsules 80 mg) or placebo (two capsules of placebo) via a nasogastric tube for 10 days. Sequential organ failure assessment (SOFA) was evaluated on days 1 and 10. Serum levels of inflammatory factors of procalcitonin (PCT), Interleukin- 6 (IL-6), tumor necrosis factor-alpha, (TNF-α),and high-sensitive C-reactive protein (hs-CRP) were measured before the beginning of the intervention and on days 5 and 10. Length of hospital stay, mortality rate, and mechanical ventilation duration was compared between groups.
Results
Serum levels of PCT (p = 0.002), IL-6 (p = 0.012), and TNF-α (p = 0.026) in the nano curcumin group on day 10 were significantly lower than in the placebo group. The duration of mechanical ventilation in the nano curcumin group was remarkably (p = 0.038) lower than in the placebo group. Also, the SOFA score significantly (p = 0.005) decreased in the intervention group compared to the placebo group. No significant difference was observed in the mean serum levels of hs-CRP, duration of the intensive care unit stay, and mortality rates between the study groups.
Conclusions
Our study indicated that nano curcumin could decrease the levels of inflammatory factors, duration of mechanical ventilation, and organ failure in critically ill patients.