The effect of phytosomal curcumin supplementation on inflammation, length of stay and 28-day mortality in multiple trauma patients admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
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Protocol summary
Group 1) Patients receiving placebo, 14 mg capsules of maltodextrin per day for 14 days (n = 25)
Group 2) Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 14 days (25 patients)
Group 1) Patients receiving placebo, 250 mg capsules of maltodextrin per day for 7 days (n = 25)
Group 2) Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 7 days (25 patients)
Group 1) Patients receiving placebo, 14250 mg capsules of maltodextrin per day for 147 days (n = 25) Group 2) Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 147 days (25 patients)
گروه 1) بیمارانی که به مدت 14 روز دارونما، 2 کپسول 250 میلی گرمی مالتودکسترین در روز دریافت می کنند (25 نفر)
گروه 2) بیمارانی که به مدت 14 روز دو کپسول 250 میلی گرم کورکومین-فیتوزومال (در مجموع روزانه 500 میلیگرم) دریافت می کنند (25 نفر)
گروه 1) بیمارانی که به مدت 7 روز دارونما، 2 کپسول 250 میلی گرمی مالتودکسترین در روز دریافت می کنند (25 نفر)
گروه 2) بیمارانی که به مدت 7 روز دو کپسول 250 میلی گرم کورکومین-فیتوزومال (در مجموع روزانه 500 میلیگرم) دریافت می کنند (25 نفر)
گروه 1) بیمارانی که به مدت 147 روز دارونما، 2 کپسول 250 میلی گرمی مالتودکسترین در روز دریافت می کنند (25 نفر) گروه 2) بیمارانی که به مدت 147 روز دو کپسول 250 میلی گرم کورکومین-فیتوزومال (در مجموع روزانه 500 میلیگرم) دریافت می کنند (25 نفر)
Intervention groups
#1
Intervention group: Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 14 days (25 patients)
Intervention group: Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 7 days (25 patients)
Intervention group: Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 147 days (25 patients)
گروه مداخله: بیمارانی که به مدت 14 روز دو کپسول 250 میلی گرم کورکومین-فیتوزومال (در مجموع روزانه 500 میلیگرم) دریافت می کنند (25 نفر)
گروه مداخله: بیمارانی که به مدت 7 روز دو کپسول 250 میلی گرم کورکومین-فیتوزومال (در مجموع روزانه 500 میلیگرم) دریافت می کنند (25 نفر)
گروه مداخله: بیمارانی که به مدت 147 روز دو کپسول 250 میلی گرم کورکومین-فیتوزومال (در مجموع روزانه 500 میلیگرم) دریافت می کنند (25 نفر)
#2
Control group: Patients receiving placebo for 14 days, 2 250 mg maltodextrin capsules per day (25 patients)
Control group: Patients receiving placebo for 7 days, 2 250 mg maltodextrin capsules per day (25 patients)
Control group: Patients receiving placebo for 147 days, 2 250 mg maltodextrin capsules per day (25 patients)
گروه کنترل: بیمارانی که به مدت 14 روز دارونما، 2 کپسول 250 میلی گرمی مالتودکسترین در روز دریافت می کنند (25 نفر)
گروه کنترل: بیمارانی که به مدت 7 روز دارونما، 2 کپسول 250 میلی گرمی مالتودکسترین در روز دریافت می کنند (25 نفر)
گروه کنترل: بیمارانی که به مدت 147 روز دارونما، 2 کپسول 250 میلی گرمی مالتودکسترین در روز دریافت می کنند (25 نفر)
Protocol summary
Study aim
Evaluation of the effect of phytosomal curcumin supplementation in multiple trauma patients admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
Design
This double-blind, randomized trial is performed by Excel software on 50 patients.
Settings and conduct
in this double-blind randomized clinical trial study, 50 patients aged 20 to 60 years with multiple trauma admitted to the intensive care unit (ICU) of Al-Zahra Hospital are randomly divided into two groups after having inclusion criteria:
Participants/Inclusion and exclusion criteria
Participants: 50 patients aged 20 to 60 years with multiple trauma admitted to the intensive care unit (ICU)
Inclusion criteria:
, gastrointestinal tract with normal function and intestinal nutrition criteria, diagnosis of sepsis based on blood culture and approval of an ICU and anesthesiologist and infectious disease specialist
Exclusion criteria: Impossibility of intestinal nutrition in the first 48 hours of admission, any history of underlying heart disease, patients who are hospitalized in the intensive care unit for less than 48 hours. Patients who are expected to die within 12 hours of admission to the intensive care unit. Patients with BMI <18.5kg / m2 admitted to the intensive care unit. Patients who receive nutritional support with complete intravenous feeding.
Intervention groups
Group 1) Patients receiving placebo, 250 mg capsules of maltodextrin per day for 7 days (n = 25)
Group 2) Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 7 days (25 patients)
Main outcome variables
Inflammation, length of stay and mortality 28 days in patients with multiple trauma admitted to ICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090306001747N1
Registration date:2021-01-12, 1399/10/23
Registration timing:prospective
Last update:2022-03-03, 1400/12/12
Update count:2
Registration date
2021-01-12, 1399/10/23
Registrant information
Name
Saeed Abbasi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
s_abbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of phytosomal curcumin supplementation on inflammation, length of stay and 28-day mortality in multiple trauma patients admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
Public title
Evaluation of the effect of phytosomal curcumin supplementation in multiple trauma
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years
Gastrointestinal tract with normal function and intestinal nutrition criteria
Diagnosis of moderate or severe trauma based on GCS index (4-14)
Trauma diagnosis based on Injury Severity Score (ISS) between minor to severe
Exclusion criteria:
Impossibility of intestinal feeding in the first 48 hours of admission
Any history of heart disease
Patients who are expected to die within 12 hours of admission to the intensive care unit.
Patients who do not have an indication for intestinal nutrition on the first day and are confirmed and predicted based on the diagnosis of the intensive care unit and will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml / day), high-output fistula (> 500 ml / day), intestinal inaccessibility, incomplete resuscitation and hemodynamic instability
Patients with BMI <18.5kg / m2 admitted to the intensive care unit.
Patients who receive nutritional support through complete intravenous feeding
Patients with a history of underlying disease such as diabetes, congenital and immune disorders, renal and hepatic insufficiency, and pancreatitis.
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
The unwillingness of the patient or his legal guardian to participate in the project
Patients who are hospitalized in the intensive care unit for less than 48 hours
Pregnancy and lactation Severe septic shock or sepsis
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the randomized blocking method and spss software will be used, so that according to the sample size, the size of the blocks is 4 and AABB combinations will be used. In the following, all possible modes of the combination of 4 will be listed and for each one, a code will be considered and individuals will be assigned based on them.This will be done using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to this research to be double-blind, at the beginning of the study, a set of cans containing curcumin and placebo supplements that are similar in shape and appearance were coded as A and B by someone other than the researcher, then a person who has no information about supplements and placebo The group that does not know whether it is a supplement or a placebo is poured into cans A and the other group into cans B so that the researchers and participants do not know the type of supplement received by each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
hezarjarib
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.MUI.MED.REC.1399.758
Health conditions studied
1
Description of health condition studied
sepsis
ICD-10 code
A41
ICD-10 code description
Other sepsis
Primary outcomes
1
Description
Inflammation
Timepoint
Before and after the intervention
Method of measurement
Measurement of inflammatory markers by serum
2
Description
mortality 28 days
Timepoint
Before and after the intervention
Method of measurement
Use existing statistics
3
Description
Duration of hospitalization
Timepoint
Before and after the intervention
Method of measurement
Use of questionnaire
Secondary outcomes
1
Description
Change in the number of blood cells
Timepoint
Before and after the intervention
Method of measurement
Blood cell count test
2
Description
Changes in lipid profiles
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
3
Description
Blood sugar changes
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
4
Description
Serum total protein
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
5
Description
BUN
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
6
Description
liver enzymes
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
7
Description
Blood prolactin
Timepoint
Before and after the intervention
Method of measurement
ELISA method
8
Description
serum albumin
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
9
Description
Serum creatinine
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
10
Description
NUTRIC score
Timepoint
Before and after the intervention
Method of measurement
By scoring a questionnaire including APACHE II and SOFA
11
Description
Superoxide dismutase (SOD)
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method through chemi luminicenece method
12
Description
Total Antioxidant Capacity (TAC)
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method through chemi luminicenece method
Intervention groups
1
Description
Intervention group: Patients receiving two 250 mg curcumin-phytosomal capsules (total 500 mg daily) for 7 days (25 patients)
Category
Treatment - Drugs
2
Description
Control group: Patients receiving placebo for 7 days, 2 250 mg maltodextrin capsules per day (25 patients)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Saeed Abbasi
Street address
Sefa Boulevard
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
alikiaiib@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
hezarjarib
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
saeed abbasi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
hezarjarib
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 1293
Email
s_abbasi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
saeed abbasi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
hezarjarib
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 1293
Email
s_abbasi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
saeed abbasi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Practitioner
Street address
hezarjarib
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 1293
Email
s_abbasi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
By sending an email to the following address that belongs to the executor of the project
s_abbasi@med.mui.ac.ir
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.