1- The effect of enteral curcumin on ICU admission days in septic patints
2- The effect of curcumin on SOFA score in ICU admitted septic patients
3- The effect of curcumin on ESR-CRP-TNF alpha- IL6 serum level in ICU admitted septic patients
4- The effect of curcumin on 10 days mortality rate in ICU admitted septic patients.
Design
Two arm parallel group blinded randomised clinical trial of 60 patients.
Settings and conduct
Dr. Shariaati Hospital , Tehran University of Medical Sciences, Tehran, iran
Participants/Inclusion and exclusion criteria
inclusion criteria: ICU admitted septic patient , APACHE score : 15-30, age : 18-75 years, ICU stay : at least 5 days , Entral feeding
Exclusion criteria:
entral feeding intolerance, estimation of death within 24 hours, pregnancy and breast feeding, vasopressor infusion
Intervention groups
Curcumin has been shown to have anti inflamatory effecs and can be used as a helpful complimentary medicine specially for criticlal patients admitted in ICU for sepsis and in this study the capsules used in intervention group .
Maltodextrin is a white, starchy powder that manufacturers add into many foods to improve their flavor, thickness, or shelf life. Maltodextrin is a common ingredient in packaged foods tht will fill the placebo capsules in the control group.
The effect of curcumin supplementation on inflammatory factors and prognosis in septic ICU patients
Public title
The effect of curcumin on septic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
عدم تحمل تغذیه انترال
پیش بینی مرگ طی 24 ساعت
بارداری و شیردهی
فشار سیستولیک کمتر از 90 mmHg مقاوم به درمان
Exclusion criteria:
entral feeding intolerance
estimation of death in next 24 hours
pregnancy and breast feeding
systolic blood pressure less than 90 mm-Hg resistant to therapy
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization lists are computer-based by a statistician and the participants and project managers will be completely unaware (blind) about the intervention and control groups.
Placebo capsules are identical capsules containing the same amount of maltodextrin.
Both curcumin and placebo (Maltodexterin) capsules are produced by Arjuna Natural Extract, India. The concealments of supplements will be done by a third person, and the participants and investigators are not aware of the groups’ assignments until the end of analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
Capsules are inside a sealed pocket with a specific code. Both the investigator and the nurse are unaware of the realation between the code and the type of capsule (curcumin or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Tehran University of Medical Sciences
Street address
No 506. Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1415983111
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.117
Health conditions studied
1
Description of health condition studied
sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis with septicemia
Primary outcomes
1
Description
length of stay in ICU
Timepoint
daily
Method of measurement
patient documents
Secondary outcomes
1
Description
TNF-alpha
Timepoint
0, 5 days after intervention
Method of measurement
ELISA
2
Description
IL-6
Timepoint
0, 5 days after intervention
Method of measurement
ELISA
3
Description
ESR
Timepoint
0, 5 days after intervention
Method of measurement
ELISA
4
Description
crp
Timepoint
0, 5 days after intervention
Method of measurement
ELISA
5
Description
CBC
Timepoint
0, 5 days after intervention
Method of measurement
-
Intervention groups
1
Description
Intervention group: curcumin
Category
Treatment - Devices
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Arash Heroabadi
Street address
Kargar Shomali
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 912 323 6508
Email
aheroabadi@sina.tums.ac.ur
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Street address
Shariati Hospital, Kargar Shomali Avenue
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 912 323 6508
Email
aheroabadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shariati Hospital, Kargar Shomali Avenue
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
84901
Email
aheroabadi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Safie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shariati Hospital, Kargar Shomali Avenue
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
84901
Email
dr.ghasemian5271@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arash Heroabadi
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shariati Hospital, Kargar Shomali Avenue
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
84901
Email
aheroabadi@sina.tums.ac.ir
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
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting after publication
To whom data/document is available
Our data will only be available for people working in academic institutions.
Under which criteria data/document could be used
Our data of the study will only be accessible for conducting Meta-analysis.
From where data/document is obtainable
To access the required data, the researchers can contact Dr. Arash Heroabadi: Email address:arash.heroabadi@gmail.com
What processes are involved for a request to access data/document
The applicants should provide a description of the propose of their Meta-analysis. That request will be assessed, and if we agree to the request, the data will be emailed.