Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial studyCommunity Verified icon
Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU)
Design
This study is a clinical trial with a randomized, parallel double-blind control group, in which 50 patients with coronavirus will be divided into two groups receiving curcumin-piperine supplement (n = 25) and placebo (n = 25). .
Settings and conduct
In this study, people with coronavirus in Al-Zahra Hospital will be included in the study. Random allocation will be done using a random number table. Entry of individuals and assignment of each person to one of the two groups will be done by the relevant specialist. Curcumin-piperine supplement and placebo will be packaged in similar boxes and the researcher and patients will not be informed of the contents of the packages until the end of the study.
Participants/Inclusion and exclusion criteria
Entry requirements:
Willingness to participate in the study,
Age 20-65 years,
Diagnosis of Covid-19 based on PCR findings
No entry conditions:
Sensitivity to plant products such as turmeric and pepper
Patients with a history of underlying disease
Taking anticoagulants,
People who are in severe stages of pregnancy and lactation, septic shock or sepsis.
Intervention groups
1) Patients who receive 3 capsules of 500 mg per day of curcumin-piperine for 14 days (25 people) (intervention)
Group 2) Patients receiving 3 placebo capsules for 14 days, each capsule containing 500 mg of maltodextrin per day (control) (25 patients)
Main outcome variables
Body temperature, ESR and CRP, length of hospital stay, extent and severity of patients' cough, (ALT, AST, LDH), (BUN, Creatinine), (CBC), NUTRIC score, APACHE II and SOFA score, mean blood sugar, ALBUMIN
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N52
Registration date:2021-05-13, 1400/02/23
Registration timing:prospective
Last update:2021-05-13, 1400/02/23
Update count:1
Registration date
2021-05-13, 1400/02/23
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-15, 1400/02/25
Expected recruitment end date
2021-05-29, 1400/03/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial studyCommunity Verified icon
Public title
Evaluation of the effect of curcumin in coronary hospitalized patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age 20-65 years
Diagnosis of Covid-19 based on clinical findings and PCR findings
Gastrointestinal tract with normal function and intestinal nutrition criteria
Exclusion criteria:
Age less than 20 and more than 65 years
Sensitivity to plant products such as turmeric and pepper
Impossibility of intestinal feeding in the first 48 hours of admission
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 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 that they will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml per day), high-output fistula (> 500 ml per 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 congenital and immune disorders, renal and hepatic insufficiency and pancreatitis.Community Verified icon
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
Pregnancy and lactation
Severe septic shock or sepsis
Dissatisfaction of the patient or her legal guardian
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the participants based on the inclusion criteria and obtaining the consent of the patients or their companions, the participants will be randomly divided into two groups, intervention and placebo and will be studied for 2 weeks (14 days). For this purpose, 50 patients admitted to the ICU who have already been diagnosed with COVID19 by PCR will be randomly divided into two groups (25 in the intervention group and 25 in the control group) using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to carry out this research in a double-blind manner, before starting the study, the total of the relevant capsules
Both intervention and control groups, which are similar in shape, color, and appearance, are coded A and B by someone other than the researcher to ensure that the researcher does not know the type of capsules received by both groups. Participants who were randomly divided into groups A and B received the pills for two weeks without knowing that they were in the supplement or placebo group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-08, 1400/02/18
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.057
Health conditions studied
1
Description of health condition studied
coronavirus (covid-19) disease
ICD-10 code
u07.02
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
Body temperature
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
By using clinical thermometer
2
Description
hs-CRP
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
En Enzymatic method
3
Description
Duration of hospitalization
Timepoint
At the time of discharge from the hospital
Method of measurement
By Using the patient's medical record
4
Description
severity and number of coughs
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Visual analogue scales (VAS) for cough
5
Description
ALT
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic photometric method
6
Description
AST
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic photometric method
7
Description
LDH
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic photometric method
8
Description
BUN
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
9
Description
creatinine
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
10
Description
CBC
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Device analysis using cell counter device (hematology analyzer)
11
Description
Albumin
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
12
Description
Blood sugar
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
13
Description
ESR
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
Enzymatic method
14
Description
NUTRIC score
Timepoint
Before and after the intervention
Method of measurement
By scoring a questionnaire including APACHE II and SOFA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving 3 capsules of 500 mg per day of curcumin-piperine (manufactured by Sami Lab India) for 14 days (a total of 1500 mg of curcumin per day and 15 mg of piperine per day) (25 N). These supplements are given to patients at 9 am, 3 pm and 9 pm, 6 hours apart.
Category
Treatment - Drugs
2
Description
Control group: Patients who receive 3 placebo capsules for 14 days, each capsule containing 500 mg of maltodextrin per day (total 1500 mg of maltodextrin) (25 people) These supplements at 9 am, 3 pm and 9 pm, 6 hours apart It is given to patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Ghulam Reza Askari
Street address
Sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezar Jarib
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@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
Gholamreza Askari
Position
دانشیار
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 1378
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
ISFAHAN
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared.
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
askari@mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.