Protocol summary
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Study aim
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Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU)
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Design
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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 = 30) and placebo (n = 30). .
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Entry requirements:
Willingness to participate in the study,
Age 20-80 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.
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Intervention groups
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1) Patients who receive 3 capsules of 500 mg per day of curcumin-piperine for 7 days (30 people) (intervention)
Group 2) Patients receiving 3 placebo capsules for 14 days, each capsule containing 500 mg of maltodextrin per day (control) (30 patients)
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Main outcome variables
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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
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Reason for update
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Due to the changes made, the need to make corrections was as follows:
1. The age of the participants is from 20 to 80 years
2. The number of samples reached 60 people
3. The intervention period was reduced to 7 days.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20121216011763N52
Registration date:
2021-05-13, 1400/02/23
Registration timing:
prospective
Last update:
2021-05-23, 1400/03/02
Update count:
1
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Registration date
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2021-05-13, 1400/02/23
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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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2021-05-15, 1400/02/25
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Expected recruitment end date
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2021-05-22, 1400/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluation of the effect of curcumin in coronary hospitalized patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participate in the study
Age 20-80years
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 80 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
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Age
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From 20 years old to 80 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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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 1 weeks (7 days). For this purpose, 60 patients admitted to the ICU who have already been diagnosed with COVID19 by PCR will be randomly divided into two groups (30 in the intervention group and 30 in the control group) using a random number table.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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 a week without knowing that they were in the supplement or placebo group.
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Placebo
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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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2021-05-08, 1400/02/18
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.057
Health conditions studied
1
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Description of health condition studied
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coronavirus (covid-19) disease
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ICD-10 code
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u07.02
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ICD-10 code description
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COVID-19 Disease
Primary outcomes
1
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Description
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Body temperature
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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By using clinical thermometer
2
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Description
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hs-CRP
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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En Enzymatic method
3
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Description
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Duration of hospitalization
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Timepoint
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At the time of discharge from the hospital
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Method of measurement
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By Using the patient's medical record
4
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Description
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severity and number of coughs
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Visual analogue scales (VAS) for cough
5
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Description
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ALT
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Enzymatic photometric method
6
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Description
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AST
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Enzymatic photometric method
7
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Description
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LDH
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Enzymatic photometric method
8
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Description
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BUN
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
9
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Description
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creatinine
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
10
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Description
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CBC
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Device analysis using cell counter device (hematology analyzer)
11
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Description
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Albumin
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
12
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Description
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Blood sugar
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Biochemical test by enzymatic method by Hitachi 902 device
13
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Description
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ESR
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Timepoint
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Before intervention and 2 weeks after intervention
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Method of measurement
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Enzymatic method
14
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Description
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NUTRIC score
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Timepoint
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Before and after the intervention
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Method of measurement
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By scoring a questionnaire including APACHE II and SOFA
Intervention groups
1
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Description
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Intervention group: Patients receiving 3 capsules of 500 mg per day of curcumin-piperine (manufactured by Sami Lab India) for 7 days (a total of 1500 mg of curcumin per day and 15 mg of piperine per day) (30 N). These supplements are given to patients at 9 am, 3 pm and 9 pm, 6 hours apart.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients who receive 3 placebo capsules for 7 days, each capsule containing 500 mg of maltodextrin per day (total 1500 mg of maltodextrin) (30 people) These supplements at 9 am, 3 pm and 9 pm, 6 hours apart It is given to patients.
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Category
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Placebo
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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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The collected deidentified for the primary outcome measure only will be shared.
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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askari@mui.ac.ir
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What processes are involved for a request to access data/document
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The data will send as soon as possible, after receiving the request.
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Comments
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