The effect of curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
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Protocol summary
This double-blind study was performed on patients with sepsis in the ICU of Alzahra Hospital in Isfahan. The intervention group received curcumin supplement for 2 weeks and the control group received malto dextrin supplement for 2 weeks. In this study, blindness is performed on researchers and patients who participated in the project.
This double-blind study was performed on patients with sepsis in the ICU of Alzahra Hospital in Isfahan. The intervention group received curcumin supplement for 1 week and the control group received malto dextrin supplement for 1 week. In this study, blindness is performed on researchers and patients who participated in the project.
This double-blind study was performed on patients with sepsis in the ICU of Alzahra Hospital in Isfahan. The intervention group received curcumin supplement for 2 weeks1 week and the control group received malto dextrin supplement for 2 weeks1 week. In this study, blindness is performed on researchers and patients who participated in the project.
این مطالعه به صورت دو سو کور بر روی بیماران دچار سپسیس در ICUبیمارستان الزهرا اصفهان انجام میشود که گروه مداخله به مدت 2 هفته مکمل کورکومین و گروه کنترل به مدت 2 هفته مکمل مالتو دکسترین دریافت می کنند. در این مطالعه کورسازی بر روی محققین و بیمارانی که در طرح شرکت کرده اند انجام می شود.
این مطالعه به صورت دو سو کور بر روی بیماران دچار سپسیس در ICUبیمارستان الزهرا اصفهان انجام میشود که گروه مداخله به مدت یک هفته مکمل کورکومین و گروه کنترل به مدت یک هفته مکمل مالتو دکسترین دریافت می کنند. در این مطالعه کورسازی بر روی محققین و بیمارانی که در طرح شرکت کرده اند انجام می شود.
این مطالعه به صورت دو سو کور بر روی بیماران دچار سپسیس در ICUبیمارستان الزهرا اصفهان انجام میشود که گروه مداخله به مدت 2یک هفته مکمل کورکومین و گروه کنترل به مدت 2یک هفته مکمل مالتو دکسترین دریافت می کنند. در این مطالعه کورسازی بر روی محققین و بیمارانی که در طرح شرکت کرده اند انجام می شود.
Group 1) Patients who receive 2 placebo capsules for 14 days, each capsule containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients)
Group 2) Patients receiving two 500 mg capsules of curcumin-piperine per day for 14 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
Group 1) Patients who receive 2 placebo capsules for 7 days, each capsule containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients)
Group 2) Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
Group 1) Patients who receive 2 placebo capsules for 147 days, each capsule containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients) Group 2) Patients receiving two 500 mg capsules of curcumin-piperine per day for 147 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
گروه 1) بیمارانی که به مدت 14 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (25 نفر)
گروه 2) بیمارانی که به مدت 14 روز دو کپسول 500 میلی گرمی در روز کورکومین-پیپرین دریافت می کنند (در مجموع روزی 1000 میلی گرم کورکومین و روزی 10 میلی گرم پیپرین در روز) (25 نفر)
گروه 1) بیمارانی که به مدت 7 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (25 نفر)
گروه 2) بیمارانی که به مدت 7 روز دو کپسول 500 میلی گرمی در روز کورکومین-پیپرین دریافت می کنند (در مجموع روزی 1000 میلی گرم کورکومین و روزی 10 میلی گرم پیپرین در روز) (25 نفر)
گروه 1) بیمارانی که به مدت 147 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (25 نفر) گروه 2) بیمارانی که به مدت 147 روز دو کپسول 500 میلی گرمی در روز کورکومین-پیپرین دریافت می کنند (در مجموع روزی 1000 میلی گرم کورکومین و روزی 10 میلی گرم پیپرین در روز) (25 نفر)
General information
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Due to the prevalence of COVID-19 and the allocation of intensive care units (ICUs) to these patients, the duration of the intervention changes from 14 days to 7 days.
Due to the prevalence of COVID-19 and the allocation of intensive care units (ICUs) to these patients, the duration of the intervention changes from 14 days to 7 days.
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با توجه به شیوع بیماری کرونا و اختصاص بخش های مراقبت های ویژه به بیماران کرونایی، مدت اجرای مداخله از 14 روز به 7 روز تغییر می یابد.
با توجه به شیوع بیماری کرونا و اختصاص بخش های مراقبت های ویژه به بیماران کرونایی، مدت اجرای مداخله از 14 روز به 7 روز تغییر می یابد.
The effect of curcumin piperine supplementation on inflammation, length of stay and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
The effect of curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
The effect of curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
Impossibility of intestinal feeding 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 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
Patients with BMI <18.5 kg / 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.
Pregnancy and lactation
Severe septic shock or sepsis
Dissatisfaction of the patient or her legal guardian(زن)
Impossibility of intestinal feeding 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 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
Patients with BMI <18.5 kg / 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.
Pregnancy and lactation
Severe septic shock or sepsis
Dissatisfaction of the patient or her legal guardian
Impossibility of intestinal feeding 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 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 Patients with BMI <18.5 kg / 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. Pregnancy and lactation Severe septic shock or sepsis Dissatisfaction of the patient or her legal guardian(زن)guardian
Randomization will be done through block randomization method (permuted blocked randomization). depending on the sample size , each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
This will be done using a random number table.
Randomization will be conducted using the block randomization method (permuted blocked randomization). depending on the sample size, each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
This will be done using a random number table.
Randomization will be done throughconducted using the block randomization method (permuted blocked randomization). depending on the sample size, each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient. This will be done using a random number table.
For double blinding of this study, at the beginning, cans contained zinc supplement and placebo were coded as A and B by person other than researcher to ensure researcher and participants were not informed about types of supplement received by participants
To blind both patients and investigators, in the beginning, cans containing curcumin supplement and placebo were coded as A and B by a person other than the researcher to ensure the researcher and participants were not informed about the types of supplement received by participants
For double blinding of this studyTo blind both patients and investigators, atin the beginning, cans contained zinccontaining curcumin supplement and placebo were coded as A and B by a person other than the researcher to ensure the researcher and participants were not informed about the types of supplement received by participants
جهت دوسوکور بودن این تحقیق در زمان شروع مطالعه مجموعه ی قوطی های حاوی مکمل زینک و دارونما توسط فردی غیر از محقق به صورت AوB کد گذاری شدند تا عدم اطلاع محقق و شرکت کنندگان از نوع مکمل دریافتی توسط هر گروه رعایت شود
جهت دوسوکور بودن این تحقیق در زمان شروع مطالعه مجموعه ی قوطی های حاوی مکمل کورکومین و دارونما توسط فردی غیر از محقق به صورت AوB کد گذاری شدند تا عدم اطلاع محقق و شرکت کنندگان از نوع مکمل دریافتی توسط هر گروه رعایت شود
جهت دوسوکور بودن این تحقیق در زمان شروع مطالعه مجموعه ی قوطی های حاوی مکمل زینککورکومین و دارونما توسط فردی غیر از محقق به صورت AوB کد گذاری شدند تا عدم اطلاع محقق و شرکت کنندگان از نوع مکمل دریافتی توسط هر گروه رعایت شود
Health conditions studied
#1
sepsis
Sepsis
sepsisSepsis
Intervention groups
#1
Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 14 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 147 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
گروه مداخله: بیمارانی که به مدت 14 روز دو کپسول 500 میلی گرمی در روز کورکومین-پیپرین دریافت می کنند (در مجموع روزی 1000 میلی گرم کورکومین و روزی 10 میلی گرم پیپرین در روز) (25 نفر)
گروه مداخله: بیمارانی که به مدت 7 روز دو کپسول 500 میلی گرمی در روز کورکومین-پیپرین دریافت می کنند (در مجموع روزی 1000 میلی گرم کورکومین و روزی 10 میلی گرم پیپرین در روز) (25 نفر)
گروه مداخله: بیمارانی که به مدت 147 روز دو کپسول 500 میلی گرمی در روز کورکومین-پیپرین دریافت می کنند (در مجموع روزی 1000 میلی گرم کورکومین و روزی 10 میلی گرم پیپرین در روز) (25 نفر)
#2
Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients)
Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients) for 7 days
Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients) for 7 days
گروه کنترل: بیمارانی که به مدت 14 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (25 نفر)
گروه کنترل: بیمارانی که به مدت 7 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (25 نفر)
گروه کنترل: بیمارانی که به مدت 147 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (25 نفر)
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahram Ali Kiai
Full name of responsible person - Persian: بهرام علی کیایی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: hezarjarib
Street address - Persian: هزار جریب
City - English: esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3620 1293
Mobile: +98 911 195 1374
Fax:
Email: alikiaiib@med.mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Babak Alikiaii
Full name of responsible person - Persian: بابک علی کیایی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hezarjarib
Street address - Persian: هزار جریب
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3620 1293
Mobile: +98 911 195 1374
Fax:
Email: alikiaiib@med.mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Bahram Ali KiaiBabak Alikiaii Full name of responsible person - Persian: بهرامبابک علی کیایی Position - English: Associate Professor Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 30 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: hezarjaribHezarjarib Street address - Persian: هزار جریب City - English: esfahanEsfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3620 1293 Mobile: +98 911 195 1374 Fax: Email: alikiaiib@med.mui.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: بهرام علی کیایی
Full name of responsible person - Persian: Bahram Ali Kiai
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: hezarjarib
Street address - Persian: هزارجریب
City - English: esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3620 1293
Mobile: +98 911 195 1374
Fax:
Email: alikiaiib@med.mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Babak Alikiaii
Full name of responsible person - Persian: بابک علی کیایی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hezarjarib
Street address - Persian: هزارجریب
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3620 1293
Mobile: +98 911 195 1374
Fax:
Email: alikiaiib@med.mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: بهرام علی کیاییBabak Alikiaii Full name of responsible person - Persian: Bahram Ali Kiaiبابک علی کیایی Position - English: Associate Professor Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 30 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: hezarjaribHezarjarib Street address - Persian: هزارجریب City - English: esfahanEsfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3620 1293 Mobile: +98 911 195 1374 Fax: Email: alikiaiib@med.mui.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Bahram Ali Kiai
Full name of responsible person - Persian: بهرام علی کیایی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: hezarjarib
Street address - Persian: هزار جریب
City - English: esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3620 1293
Mobile: +98 911 195 1374
Fax:
Email: alikiaiib@med.mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Babak Alikiaii
Full name of responsible person - Persian: بابک علی کیایی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 30
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Hezarjarib
Street address - Persian: هزار جریب
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3620 1293
Mobile: +98 911 195 1374
Fax:
Email: alikiaiib@med.mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Bahram Ali KiaiBabak Alikiaii Full name of responsible person - Persian: بهرامبابک علی کیایی Position - English: Associate Professor Position - Persian: دانشیار Latest degree: sub_specialist Area of specialty/work: 30 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: hezarjaribHezarjarib Street address - Persian: هزار جریب City - English: esfahanEsfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3620 1293 Mobile: +98 911 195 1374 Fax: Email: alikiaiib@med.mui.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effect of curcumin piperine supplementation in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
Design
This study is a randomized double-blind clinical trial on 50 patients. Randomization is performed by Excel software
Settings and conduct
This double-blind study was performed on patients with sepsis in the ICU of Alzahra Hospital in Isfahan. The intervention group received curcumin supplement for 1 week and the control group received malto dextrin supplement for 1 week. In this study, blindness is performed on researchers and patients who participated in the project.
Participants/Inclusion and exclusion criteria
Participants: 50 patients aged 20 to 60 years with sepsis admitted to the intensive care unit (ICU)
Inclusion criteria: age 20-60 years, gastrointestinal tract with normal function and diagnosis of sepsis
Non-entry conditions: Impossibility of intestinal feeding in the first 48 hours of admission,
Patients who are expected to die within 12 hours of admission to the intensive care unit. Patients with BMI <18.5 kg / m2 admitted to the intensive care unit.
Intervention groups
Group 1) Patients who receive 2 placebo capsules for 7 days, each capsule containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients)
Group 2) Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
Main outcome variables
Inflammation and infection in patients with sepsis in the ICU
General information
Reason for update
Due to the prevalence of COVID-19 and the allocation of intensive care units (ICUs) to these patients, the duration of the intervention changes from 14 days to 7 days.
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022681N4
Registration date:2021-01-02, 1399/10/13
Registration timing:prospective
Last update:2022-04-05, 1401/01/16
Update count:1
Registration date
2021-01-02, 1399/10/13
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 195 1374
Email address
alikiaiib@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 curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
Public title
Evaluation of the effect of curcumin piperine supplementation in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years
Gastrointestinal tract with normal function and intestinal nutrition criteria
Diagnosis of sepsis is based on blood culture and the approval of an ICU, anesthesiologist and infectious disease specialist
Exclusion criteria:
Impossibility of intestinal feeding 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 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
Patients with BMI <18.5 kg / 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.
Pregnancy and lactation
Severe septic shock or sepsis
Dissatisfaction of the patient or her legal guardian
Age
From 20 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be conducted using the block randomization method (permuted blocked randomization). depending on the sample size, each block includes 4 characters and will be used AABB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient.
This will be done using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind both patients and investigators, in the beginning, cans containing curcumin supplement and placebo were coded as A and B by a person other than the researcher to ensure the researcher and participants were not informed about the types of supplement received by participants
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
Esfahan University of Medical Sciences, Hezar Jerib street, Esfahan, Iran
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.MUI.MED.REC.1399.759
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 (via hs-CRP, Albumin, pre Albumin indices)
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 official 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 red blood cells
Timepoint
Before and after the intervention
Method of measurement
Device analysis using cell counter device (hematology analyzer)
2
Description
Serum concentration of lipid profiles including triglyceride, cholesterol, HDL, LDL
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
3
Description
Fasting Blood Sugar Concentration
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
4
Description
Superoxide dismutase (SOD)
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method through chemi luminicenece method
5
Description
Total Antioxidant Capacity (TAC)
Timepoint
Before and after the intervention
Method of measurement
Enzymatic method through chemi luminicenece method
6
Description
Serum total protein
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
7
Description
BUN
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
8
Description
Blood prolactin
Timepoint
Before and after the intervention
Method of measurement
ELISA method
9
Description
serum albumin
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
10
Description
Serum creatinine
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device
Intervention groups
1
Description
Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (25 patients)
Category
Treatment - Drugs
2
Description
Control group: Intervention group: Patients receiving 2 placebo capsules for each day containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (25 patients) for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
Bahram Ali Kiai
Street address
Al-Zahra Hospital of Isfahan, Soffe Boulevard, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
hezar jarib
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
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
Babak Alikiaii
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
alikiaiib@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
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
alikiaiib@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Alikiaii
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
alikiaiib@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
Not applicable
Title and more details about the data/document
All data can be shared at the request of individuals
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
alikiaiib@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.