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IRCT20121216011763N52 IRCT 2021-05-13 Esfahan University of Medical Sciences Evaluation of the effect of curcumin in coronary hospitalized patients 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 2021-05-15 anticipated 50 Complete https://irct.ir/trial/56149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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, 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 a week without knowing that they were in the supplement or placebo group. 3 coronavirus (covid-19) disease. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The collected deidentified for the primary outcome measure only will be shared. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: askari@mui.ac.ir How to obtain: The data will send as soon as possible, after receiving the request. Comments:
public Gholamreza Askari
Hezarjarib Ave
ISFAHAN Iran (Islamic Republic of) 81746-73461 +98 31 3668 1378 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Askari
Hezarjarib Ave
ISFAHAN Iran (Islamic Republic of) 8174673461 +98 31 1792 2110 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 20 years 80 years Both 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 u07.02 COVID-19 Disease Treatment - Drugs Placebo 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. 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. Body temperature. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: By using clinical thermometer. Hs-CRP. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: En Enzymatic method. Duration of hospitalization. Timepoint: At the time of discharge from the hospital. Method of measurement: By Using the patient's medical record. Severity and number of coughs. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Visual analogue scales (VAS) for cough. ALT. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic photometric method. AST. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic photometric method. LDH. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic photometric method. BUN. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device. Creatinine. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device. CBC. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Device analysis using cell counter device (hematology analyzer). Albumin. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device. Blood sugar. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device. ESR. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Enzymatic method. NUTRIC score. Timepoint: Before and after the intervention. Method of measurement: By scoring a questionnaire including APACHE II and SOFA. Esfahan University of Medical Sciences Approved 2021-05-08 Ethics committe of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)