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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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History
# Registration date Revision Id
3 2025-05-18, 1404/02/28 342742
2 2022-03-19, 1400/12/28 221698
1 2021-01-02, 1399/10/13 165652
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  • Protocol summary

    This study is a randomized double-blind clinical trial on 50 patients. Randomization is performed by Excel software
    This study is a randomized double-blind clinical trial on 66 patients. Randomization is performed by Excel software
    این کارآزمایی به صورت دوسویه کور و تصادفی شده توسط نرم افزار اکسل بر روی 50 بیمار انجام می شود
    این کارآزمایی به صورت دوسویه کور و تصادفی شده توسط نرم افزار اکسل بر روی 66 بیمار انجام می شود
    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.
    Participants: 66 patients aged 20 to 75 years with sepsis admitted to the intensive care unit (ICU) Inclusion criteria: age 20-75 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.
    شرکت کنندگان: 50 بیمار 20 تا 60 ساله مبتلا به سپسیس بستری در بخش مراقبت های ویژه (ICU) شرایط ورود: سن 20-60 سال، دستگاه گوارش با عملکرد نرمال و تشخیص سپسیس شرایط عدم ورود: عدم امکان تغذیه روده ای در 48 ساعت اول پذیرش، بیمارانی که پیش بینی می شود ظرف 12 ساعت از پذیرش در بخش مراقبت های ویژه فوت کنند. بیمارانی با نمایه توده بدنی BMI<18.5kg/m2 که در بخش مراقبت های ویژه پذیرش می شوند.
    شرکت کنندگان: 66 بیمار 20 تا 75 ساله مبتلا به سپسیس بستری در بخش مراقبت های ویژه (ICU) شرایط ورود: سن 20-75 سال، دستگاه گوارش با عملکرد نرمال و تشخیص سپسیس شرایط عدم ورود: عدم امکان تغذیه روده ای در 48 ساعت اول پذیرش، بیمارانی که پیش بینی می شود ظرف 12 ساعت از پذیرش در بخش مراقبت های ویژه فوت کنند. بیمارانی با نمایه توده بدنی BMI<18.5kg/m2 که در بخش مراقبت های ویژه پذیرش می شوند.
    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 7 days, each capsule containing 500 mg of maltodextrin per day (total 1000 mg of maltodextrin) (33 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) (33 patients)
    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 7 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (33 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) (33 نفر)

  • General information

    1
    1
    50
    66
    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.
    "To enhance the statistical power of the study, we propose increasing the sample size to 66 participants and revising the age-related (20-75 years) inclusion criteria."
    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.
    برای افزایش قدرت آماری مطالعه، پیشنهاد می‌کنیم حجم نمونه به ۶۶ شرکت‌کننده افزایش یابد و معیارهای ورود به مطالعه بر اساس سن (۲۰ تا ۷۵ سال) اصلاح شود.
    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
    Age 20-75 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
    سن 20-60 سال
    دستگاه گوارش با عملکرد نرمال و دارای معیارهای تغذیه روده ای
    تشخیص سپسیس بر اساس کشت خون و تایید یک پزشک فوق تخصص ICU و بیهوشی و متخصص عفونی
    سن 20-75 سال
    دستگاه گوارش با عملکرد نرمال و دارای معیارهای تغذیه روده ای
    تشخیص سپسیس بر اساس کشت خون و تایید یک پزشک فوق تخصص ICU و بیهوشی و متخصص عفونی
    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 uncontrolled 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
    عدم امکان تغذیه روده ای در 48 ساعت اول پذیرش
    هر نوع سابقه بیماری قلبی زمینه ای
    بیمارانی که کمتر از 48 ساعت در بخش مراقبت های ویژه بستری باشند
    بیمارانی که پیش بینی می شود ظرف 12 ساعت از پذیرش در بخش مراقبت های ویژه فوت کنند.
    بیمارانی که در روز اول اندیکاسیون تغذیه روده ای را ندارند و براساس تشخیص بخش مراقبت های ویژه تایید و پیش بینی می شود که در آینده نیز قادر به دریافت تغذیه روده ای نمی باشند. (تهوع، استفراغ مقاوم، ایلئوس، انسداد روده، اسهال کنترل نشده (> 500 میلی لیتر در روز)، فیستول با خروجی بالا (> 500 میلی لیتر در روز)، عدم دسترسی به روده، احیاء ناقص و بی ثباتی همودینامیک
    بیمارانی با نمایه توده بدنی BMI<18.5kg/m2 که در بخش مراقبت های ویژه پذیرش می شوند.
    بیمارانی که تحت حمایت تغذیه ای به روش تغذیه وریدی کامل قرار می گیرند
    بیمارانی که سابقه بیماری زمینه ای از قبیل دیابت، اختلالات مادرزادی و ایمنی، نارسایی کلیوی و کبدی و پانکراتیت دارند.
    مصرف داروهای ضد انعقاد خون مانند هپارین، وارفارین، آسپیرین و غیره
    بارداری و شیردهی
    شوک سپتیک یا سپسیس شدید
    عدم رضایت بیمار یا ولی قانونی وی
    عدم امکان تغذیه روده ای در 48 ساعت اول پذیرش
    هر نوع سابقه بیماری قلبی زمینه ای
    بیمارانی که کمتر از 48 ساعت در بخش مراقبت های ویژه بستری باشند
    بیمارانی که پیش بینی می شود ظرف 12 ساعت از پذیرش در بخش مراقبت های ویژه فوت کنند.
    بیمارانی که در روز اول اندیکاسیون تغذیه روده ای را ندارند و براساس تشخیص بخش مراقبت های ویژه تایید و پیش بینی می شود که در آینده نیز قادر به دریافت تغذیه روده ای نمی باشند. (تهوع، استفراغ مقاوم، ایلئوس، انسداد روده، اسهال کنترل نشده (> 500 میلی لیتر در روز)، فیستول با خروجی بالا (> 500 میلی لیتر در روز)، عدم دسترسی به روده، احیاء ناقص و بی ثباتی همودینامیک
    بیمارانی با نمایه توده بدنی BMI<18.5kg/m2 که در بخش مراقبت های ویژه پذیرش می شوند.
    بیمارانی که تحت حمایت تغذیه ای به روش تغذیه وریدی کامل قرار می گیرند
    بیمارانی که سابقه بیماری زمینه ای از قبیل دیابت کنترل نشده، اختلالات مادرزادی و ایمنی، نارسایی کلیوی و کبدی و پانکراتیت دارند.
    مصرف داروهای ضد انعقاد خون مانند هپارین، وارفارین، آسپیرین و غیره
    بارداری و شیردهی
    شوک سپتیک یا سپسیس شدید
    عدم رضایت بیمار یا ولی قانونی وی

  • Secondary outcomes

    #1
    Superoxide dismutase (SOD)
    Serum total protein
    سوپراکسید دیسموتاز (SOD)
    توتال پروتئین سرم
    Enzymatic method through chemi luminicenece method
    Biochemical test by enzymatic method by Hitachi 902 device
    روش آنزیماتیک از طریق متد chemi luminicenece
    آزمایش بیوشیمیایی با روش آنزیماتیک توسط دستگاه هیتاچی 902
    #2
    Total Antioxidant Capacity (TAC)
    BUN
    ظرفیت آنتی اکسیدانی تام (TAC)
    BUN
    قبل و بعد از مداخله
    ابتدا وانتهای مداخله
    Enzymatic method through chemi luminicenece method
    Biochemical test by enzymatic method by Hitachi 902 device
    روش آنزیماتیک از طریق متد chemi luminicenece
    آزمایش بیوشیمیایی با روش آنزیماتیک توسط دستگاه هیتاچی 902
    #3
    Serum total protein
    Blood prolactin
    توتال پروتئین سرم
    پرولاکتین خون
    ابتدا و انتهای مداخله
    ابتدا وانتهای مداخله
    Biochemical test by enzymatic method by Hitachi 902 device
    ELISA method
    آزمایش بیوشیمیایی با روش آنزیماتیک توسط دستگاه هیتاچی 902
    روش الایزا
    #4
    BUN
    serum albumin
    BUN
    آلبومین سرم
    #5
    Blood prolactin
    Serum creatinine
    پرولاکتین خون
    کراتینین سرم
    ابتدا وانتهای مداخله
    ابتدا و انتهای مداخله
    ELISA method
    Biochemical test by enzymatic method by Hitachi 902 device
    روش الایزا
    آزمایش بیوشیمیایی با روش آنزیماتیک توسط دستگاه هیتاچی 902
    #6
    serum albumin
    empty
    آلبومین سرم
    empty
    Before and after the intervention
    empty
    ابتدا وانتهای مداخله
    empty
    Biochemical test by enzymatic method by Hitachi 902 device
    empty
    آزمایش بیوشیمیایی با روش آنزیماتیک توسط دستگاه هیتاچی 902
    empty
    #7
    Serum creatinine
    empty
    کراتینین سرم
    empty
    Before and after the intervention
    empty
    ابتدا و انتهای مداخله
    empty
    Biochemical test by enzymatic method by Hitachi 902 device
    empty
    آزمایش بیوشیمیایی با روش آنزیماتیک توسط دستگاه هیتاچی 902
    empty

  • Intervention groups

    #1
    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 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (33 patients)
    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 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) (33 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) 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) (33 patients) for 7 days
    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 7 روز 2 کپسول دارونما هر کپسول حاوی 500 میلی گرم مالتودکسترین در روز دریافت می کنند (در مجموع 1000 میلی گرم مالتودکسترین) (33 نفر)

  • Recruitment centers

    #1
    Name of recruitment center - English: Al-Zahra Hospital of Isfahan
    Name of recruitment center - Persian: بیمارستان الزهرای اصفهان
    Full name of responsible person - English: Bahram Ali Kiai
    Full name of responsible person - Persian: بهرام علی کیایی
    Street address - English: Al-Zahra Hospital of Isfahan, Soffe Boulevard, Isfahan
    Street address - Persian: اصفهان - بلوار صفه - بیمارستان
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Fax:
    Email: alzahra@mui.ac.ir
    Web page address:
    Name of recruitment center - English: Al-Zahra Hospital of Isfahan
    Name of recruitment center - Persian: بیمارستان الزهرا اصفهان
    Full name of responsible person - English: Babak Alikiaii
    Full name of responsible person - Persian: بابک علی کیایی
    Street address - English: Al-Zahra Hospital of Isfahan, Soffe Boulevard, Isfahan
    Street address - Persian: اصفهان - بلوار صفه - بیمارستان
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174675731
    Phone: +98 31 3620 2020
    Fax:
    Email: alzahra@mui.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Shaghayegh Haghjoo Javanmard
    Full name of responsible person - Persian: دکتر شقایق حق جوی جوانمرد
    Street address - English: hezar jarib
    Street address - Persian: هزار جریب
    City - English: اصفهان
    City - Persian: esfahan
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3668 0048
    Fax:
    Email: sh_haghjoo@med.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Shaghayegh Haghjoo Javanmard
    Full name of responsible person - Persian: دکتر شقایق حق جوی جوانمرد
    Street address - English: Hezar Jarib
    Street address - Persian: هزار جریب
    City - English: Esfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3668 0048
    Fax:
    Email: sh_haghjoo@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 66 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: 66 patients aged 20 to 75 years with sepsis admitted to the intensive care unit (ICU) Inclusion criteria: age 20-75 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) (33 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) (33 patients)
Main outcome variables
Inflammation and infection in patients with sepsis in the ICU

General information

Reason for update
"To enhance the statistical power of the study, we propose increasing the sample size to 66 participants and revising the age-related (20-75 years) inclusion criteria."
Acronym
IRCT registration information
IRCT registration number: IRCT20150613022681N4
Registration date: 2021-01-02, 1399/10/13
Registration timing: prospective

Last update: 2025-06-02, 1404/03/12
Update count: 2
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 20-75 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 uncontrolled 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
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 66
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
Isfahan University of Medical Sciences, Hezar Jerib street, Esfahan, Iran
City
Isfahan
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
Serum total protein
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device

5

Description
BUN
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device

6

Description
Blood prolactin
Timepoint
Before and after the intervention
Method of measurement
ELISA method

7

Description
serum albumin
Timepoint
Before and after the intervention
Method of measurement
Biochemical test by enzymatic method by Hitachi 902 device

8

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) (33 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) (33 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
Babak Alikiaii
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
Esfahan
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.
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