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The Effect of curcumin on oxidative indices, inflammatory factors and Sequential Organ Failure Assessment Score in patients with systemic inflammatory response syndrome

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History
# Registration date Revision Id
2 2023-08-13, 1402/05/22 276022
1 2017-12-15, 1396/09/24 29766
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  • Protocol summary

    1- Determination and comparison of curcumin supplement effects on oxidative indices (MDA, TAC) in supplement curcumin receiving group and control group in Patients with SIRS. 2-Determination and comparison of curcumin supplement effects on inflammatory indices (TNF-α, IL-6) in supplement curcumin receiving group and control group in Patients with SIRS. 3- Determination and comparison of curcumin supplement effects on SOFA index in supplement curcumin receiving group and control group in patients with SIRS.
    1- Determining and comparing the effect of curcumin supplementation on oxidative indices in patients with systemic inflammatory response syndrome (SIRS). 2- Determining and comparing the effect of curcumin supplementation on inflammatory indicators in patients with SIRS. 3- Determining and comparing the effect of curcumin supplementation on the SOFA index in patients with SIRS
    - تعیین و مقایسه‌ی اثر مکمل کورکومین بر شاخص‌های اکسیداتیو(MDA ,TAC)، در گروه دریافت کننده‌ی مکمل کورکومین با گروه کنترل در بیماران مبتلا به سندروم پاسخ التهاب سیستمیک (SIRS) . - تعیین و مقایسه‌ی اثر مکمل کورکومین بر شاخص‌های التهابی (TNF-α, IL-6)، در گروه دریافت کننده‌ی مکمل کورکومین با گروه کنترل در بیماران مبتلا به SIRS. - تعیین و مقایسه‌ی اثرمکمل کورکومین بر شاخص SOFA در گروه دریافت کننده‌ی مکمل کورکومین و گروه کنترل در بیماران مبتلا به SIRS.
    - تعیین و مقایسه‌ی اثر مکمل کورکومین بر شاخص‌های اکسیداتیو، در بیماران مبتلا به سندروم پاسخ التهاب سیستمیک (SIRS) . - تعیین و مقایسه‌ی اثر مکمل کورکومین بر شاخص‌های التهابی ، در بیماران مبتلا به SIRS. - تعیین و مقایسه‌ی اثرمکمل کورکومین بر شاخص SOFA در بیماران مبتلا به SIRS
    In this study 40 patients aged 18-50 years with systemic inflammatory response syndrome (SIRS positive) are select in ICU.In the ICU Patients who eligible for inclusion criteria were diagnosed (based on the APACHEII score on the first day for homogenization of patients), the samples collect from these patients. Participants are randomly assigned to RAS software by random block method in one of two groups of curcumin or control group. Each participant is being assigned a code.
    In this study 40 patients aged 18-50 years with systemic inflammatory response syndrome (SIRS positive) are selected in ICU Participants are randomly assigned to RAS software by random block method in one of two groups of curcumin or a control group.
    در این مطالعه 40 بیمار 18 تا 50 ساله مبتلا به سندروم پاسخ التهابی سیستمیک (SIRS مثبت) در بخش ICUانتخاب می شوند. بعد از ورود به بخش ICU پس از انکه بیماران واجد شرایط معیارهای ورود به مطالعه تشخیص داده شدند (بر اساس رتبه بندی APACHEII در روز اول جهت همگن سازی بیماران). نمونه‌ها از بین بیماران گرفته خواهد شد. شرکت کنندگان به بصورت تصادفی توسط نرم افزار RAS به روش بلوک‌های تصادفی در یکی از دو گروه کورکومین و یا گروه شاهد قرار می‌گیرند. به هر یک از شرکت کنندگان یک کد اختصاص داده می شود.
    در این مطالعه 40 بیمار 18 تا 50 ساله مبتلا به سندروم پاسخ التهابی سیستمیک (SIRS مثبت) در بخش ICUانتخاب می شوند. شرکت کنندگان به بصورت تصادفی توسط نرم افزار RAS به روش بلوک‌های تصادفی در یکی از دو گروه کورکومین و یا گروه شاهد قرار می‌گیرند.
    After selecting samples from Imam Reza Hospital in Tabriz, pateints were randomly assigned to one of the two supplement curcumin and control groups. The Intervention group (two 80 mg capsules) will receive 160 mg / day curcumin at least 1 hour interval with the received fluids, and the control group will receive the usual formulation without supplementation. On the first day and on the 10th day of the study, the SOFA questionnaire will complete the nutritional status of the patients. To determine the nutritional status of patients, the new formulas will be used to indirectly measure height and weight (using Ulna Length) and the middle of the arm and the body index (BMI) will be calculated after determining the height and weight.Also, the amount of energy intake and macro nutrients will be calculated by measuring the received form of each patient during the study period. The patient's formula will be designed after measurement and calculations (based on height, weight, physiological status and type of disease, surgery) and on how to prepare, quantity and time of use will be monitored.The combinesin of patients Formula will be different according to their nutritional requirements and will be considered as a confounding factor in the evaluation and statistical analysis. The APACHEII questionnaire will also be completed at the beginning of the study for each patient. Also, on the first day and on the tenth day, the study will be as much as 5 cc Blood samples were taken from patients to determine and compare the effects of curcumin supplementation between the two groups receiving the complement of curcumin and the control group on the levels of inflammatory factors, oxidative indices and SOFA and will be evaluated and verified according to the instructions.
    After selecting the samples from Imam Reza Tabriz Hospital, the patients are placed in one of two curcumin and control groups. On the first, fifth and tenth day of the study,the SOFA questionnaire, nutritional status will be completed for the patients.Also, 5 cc of blood will be taken from the patients
    بعد از انتخاب نمونه ها از بیمارستان امام رضا(ع) تبریز بیماران در یکی از دو گروه مکمل کورکومین و شاهد قرار می‌گیرند. گروه مداخله (دو کپسول 80 میلی گرم) 160 میلی گرم در روز کورکومین حداقل با 1 ساعت فاصله به همراه مایعات دریافتی و گروه شاهد فورمولای معمول را بدون مکمل دریافت خواهند کرد. در روز نخست و در روز دهم مطالعه، پرسشنامه SOFA، وضعیت تغذیه‌ای برای بیماران تکمیل خواهد شد. برای تعیین وضعیت تغذیه‌ای بیماران از فرمول‌های موجود برای اندازه‌گیری غیرمستقیم قد و وزن (با استفاده از اندازه‌گیری طول بازو (Ulna Length) و دور وسط بازو استفاده خواهد شد و پس از تعیین قد و وزن شاخص نمایه‌ی بدنی (BMI) محاسبه خواهد شد. همچنین میزان دریافتی انرژی، و درشت مغذی‌ها با اندازه‌گیری مقدار دریافتی فورمولای هر بیمار در مدت زمان مطالعه محاسبه خواهد شد. فورمولای بیمار پس از اندازه‌گیری و محاسبات مورد نیاز (براساس قد، وزن، وضعیت فیزیولوژیک و نوع بیماری، جراحی)، طراحی خواهد شد و بر نحوه‌ی تهیه، مقدار و زمان استفاده نظارت خواهد شد. ترکیب فورمولای بیماران براساس احتیاجات تغذیه‌ای آنها متفاوت خواهد بود و به عنوان عامل مخدوشگر در ارزیابی‌ها و تجزیه تحلیل آماری در نظر گرفته خواهد شد.پرسشنامه APACHEII نیز در ابتدای مطالعه برای هر بیمار تکمیل خواهد شد. همچنین در روز نخست و در روز دهم مطالعه به میزان cc5 خون از بیماران جهت تعیین و مقایسه اثرات مکمل کورکومین در میان دو گروه دریافت کننده مکمل کورکومین و گروه شاهد برسطوح فاکتورهای التهابی ، شاخص‌های اکسیداتیو وSOFA گرفته خواهد شد و طبق دستور العمل ارزیابی و بررسی می شود.
    بعد از انتخاب نمونه ها از بیمارستان امام رضا(ع) تبریز بیماران در یکی از دو گروه مکمل کورکومین و شاهد قرار می‌گیرند. در روز نخست ، پنجم و در روز دهم مطالعه، پرسشنامه SOFA، وضعیت تغذیه‌ای برای بیماران تکمیل خواهد شد. همچنین میزان cc5 خون از بیماران جهت تعیین و مقایسه اثرات مکمل کورکومین در میان دو گروه دریافت کننده مکمل کورکومین و گروه شاهد برسطوح فاکتورهای التهابی ، شاخص‌های اکسیداتیو وSOFA گرفته خواهد شد
    معیارهای ورودبه مطالعه : بیماران بدحال بستری در ICU با نمره 15APACHE II تا 30؛ SIRS مثبت؛ داشتن سن بالای 18 سال و زیر60 سال؛ بستری شدن حداقل به مدت 10 روز در ICU؛ افراد دریافت کننده فورمولای تغذیه‌ی انترال؛ معیارهای عدم ورود به مطالعه: تغذیه‌ی وریدی؛ عدم تحمل تغذیه انترال و محلول گاواژ؛ بیمارانی که انتظار مرگ آنها در 24 آینده می رود؛ بیماران با HIV مثبت؛ خانم‌های باردار و شیرده؛ انسداد روده؛ دیابت ملیتوس؛ سندروم روده کوتاه؛ پانکراتیت؛ اختلال ایمنی
    معیارهای ورودبه مطالعه : بیماران بدحال بستری در ICU با نمره 15APACHE II تا 30؛ SIRS مثبت؛ داشتن سن بالای 18 سال و زیر60 سال؛ بستری شدن حداقل به مدت 10 روز در ICU؛ افراد دریافت کننده فورمولای تغذیه‌ی انترال؛ معیارهای عدم ورود به مطالعه: تغذیه‌ی وریدی؛ عدم تحمل تغذیه انترال و محلول گاواژ؛ بیمارانی که انتظار مرگ آنها در 24 آینده می رود؛ خانم‌های باردار و شیرده؛ انسداد روده؛ دیابت ملیتوس؛ سندروم روده کوتاه؛ پانکراتیت؛ اختلال ایمنی
    The intervention group (two 80 mg capsules) will receive 160 mg / day curcumin at least 1 hour interval with the received fluids, and the control group will receive the usual formulation without supplementation. The control group will receive the usual formulation without supplementation. Which include carbohydrates and calories in patients with serum containing dextrose (1.3 and 3.2 and D5W)
    The intervention group (two 80 mg capsules) will receive 160 mg / day curcumin The control group will receive the usual formulation without supplementation.
    گروه مداخله (دو کپسول 80 میلی گرم) 160 میلی گرم در روز کورکومین حداقل با 1 ساعت فاصله به همراه مایعات دریافتی و گروه شاهد فورمولای معمول را بدون مکمل دریافت خواهند کرد. گروه کنترل فورمولای معمول را بدون مکمل دریافت خواهند کرد. که شامل کربوهیدرات و کالری دریافتی بیمارانی که سرم‌های حاوی دکستروز (3/1و 3/2 و D5W) خواهد بود
    گروه مداخله (دو کپسول 80 میلی گرم) 160 میلی گرم در روز کورکومین گروه کنترل فورمولای معمول را بدون مکمل دریافت خواهند کرد.
    1- Assessment of oxidative indices (MDA, TAC) 2- Assessment of inflammatory factors (TNF-α, IL-6) 3. Assessment of SOFA index 4. Assessment of nutrition status
    1- Assessment of oxidative indices 2- Assessment of inflammatory factors 3. Assessment of SOFA index 4. Assessment of nutrition status 5. Assessment of biochemical factors
    بررسی شاخص‌های اکسیداتیو (MDA ,TAC)؛ بررسی شاخص‌های التهابی (TNF-α ,IL-6)؛ بررسی شاخص SOFA؛ بررسی وضعیت تغذیه ی؛
    بررسی شاخص‌های اکسیداتیو ؛ بررسی شاخص‌های التهابی؛ بررسی شاخص SOFA؛ بررسی وضعیت تغذیه ی؛ بررسی فاکتور های بیوشیمیای

  • General information

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    40
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    2018-11-19, 1397/08/28
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    2019-08-27, 1398/06/05
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    2019-08-27, 1398/06/05
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    Publishing some of the study results and updating the modified factors related to the disease
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    چاپ شدن تعدادی از نتایج مطالعه و به روز رسانی فاکتور های اصلاح شده مرنبط با بیماری
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  • Primary outcomes

    #1
    First day and tenth day
    First, fifth, and tenth day
    روز اول و روز 10
    روز اول ، پنجم و روز 10
    Interleukin 6 and tumor necrosis factor alpha
    Interleukin 6 and tumor necrosis factor-alpha, Forkhead box P3, NLR family pyrin domain containing 3, interferon-gamma, and nuclear factor kappa B, high mobility group box 1, Interleukin 8 ,Interleukin 17 and Interleukin 22, Interleukin 10, presepsin, TLR4, ICAM- 1, VCAM-1and PCT
    اینترلوکین6 و فاکتور نکروز تومور آلفا
    اینترلوکین6 و فاکتور نکروز تومور آلفا، اینترلوکین 17،اینتر لوکین8 ، اینتر لوکین 22، اینتر لوکین 10 ، اینتر فرون گاما،پروتئین FOXP3، اکتور هسته‌ای تقویت‌کنندهٔ زنجیرهٔ سبک کاپا، کرایوپایرین، پرسپسین, گیرنده‌های ناقوسی‌شکل شماره ۴, ملکول چسبندگی داخل‌سلولی ۱, مولکول چسبان عروقی-1، پروکلسیتونین
    #2
    First day and tenth day
    First, fifth, and tenth day
    روز 1 و روز 10
    روز اول ، پنجم و روز 10
    Total antioxidant capacity and malondialdehyde
    Total antioxidant capacity and malondialdehyde, Nrf2,SOD, GPX, BAX, BCL2
    ظرفیت انتی اکسیدانی کل و مالون دی آلدهید
    ظرفیت انتی اکسیدانی کل و مالون دی آلدهید،فاکتور شبه هسته‌ای 2و سوپر اکسید دیس موتاز، گلوتاتیون پراسکیداز،پروتئین ایکس مرتبط با لنفوم ۲ لنفوسیت‌های بیو، لنفومای ۲ لنفوسیت‌های بی
    #3
    First day and tenth day
    First, fifth, and tenth day
    روز 1 و روز 10
    روز اول ، پنجم و روز 10

  • Secondary outcomes

    #1
    First day and tenth day
    روز1، 5و روز 10
    روز1 و روز 10
    روز1، 5و روز 10
    #2
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    Biochemical factors
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    فاکتور های بیوشیمیای
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    روز1، 5و روز 10
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    روز1، 5و روز 10
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    Biochemistry kit
    empty
    کیت بیوشیمیای

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Ata Mahmodpour
    Full name of responsible person - Persian: دکتر عطا محمودپور
    Street address - English: Golgasht Street
    Street address - Persian: خیابان گلگشت
    City - English: tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166/15731
    Phone: +98 41 3334 7056
    Fax:
    Email: amahmoodpoor@yahoo.com
    Web page address:
    Name of recruitment center - English: Imam Reza Hospital
    Name of recruitment center - Persian: بیمارستان امام رضا (ع)
    Full name of responsible person - English: Dr. Ata Mahmodpour
    Full name of responsible person - Persian: دکتر عطا محمودپور
    Street address - English: Golgasht Street
    Street address - Persian: خیابان گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166/15731
    Phone: +98 41 3334 7056
    Fax:
    Email: Amahmoodpoor@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abolghasem Jouyban
    Full name of responsible person - Persian: دکتر ابوالقاسم جویبان
    Street address - English: Golgasht street, Tabriz University Of Medical Science, Tabriz
    Street address - Persian: تبریز- خیابان گلگشت- دانشگاه علوم پزشکی تبریز
    City - English: tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3334 0634
    Fax:
    Email: tarighata@tbzmed.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abolghasem Jouyban
    Full name of responsible person - Persian: دکتر ابوالقاسم جویبان
    Street address - English: Golgasht street, Tabriz University Of Medical Science, Tabriz
    Street address - Persian: تبریز- خیابان گلگشت- دانشگاه علوم پزشکی تبریز
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3334 0634
    Fax:
    Email: Tarighata@tbzmed.ac.ir
    Web page address:

  • Sharing plan

    undecided
    no
    undecided
    na
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    Some data has not been printed yet
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    هنوز برخی از داده ها چاپ نشده است

  • Trial results

    No
    Yes
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    2023-08-21, 1402/05/30
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    2020-04-28, 1399/02/09
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    https://www.sciencedirect.com/science/article/abs/pii/S1876382019309886
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    Introduction Sepsis is a severe reaction and excessive immune response to infection, which can lead to tissue damage, organ dysfunction, and death. This study aimed to investigate the protective effect of curcumin on inflammatory factors and clinical outcomes in patients with sepsis. Methods This randomized clinical trial was conducted on 40 patients with sepsis aged 18–55 years, who received 160 mg of nano curcumin supplement (two capsules 80 mg) or placebo (two capsules of placebo) via a nasogastric tube for 10 days. Sequential organ failure assessment (SOFA) was evaluated on days 1 and 10. Serum levels of inflammatory factors of procalcitonin (PCT), Interleukin- 6 (IL-6), tumor necrosis factor-alpha, (TNF-α),and high-sensitive C-reactive protein (hs-CRP) were measured before the beginning of the intervention and on days 5 and 10. Length of hospital stay, mortality rate, and mechanical ventilation duration was compared between groups. Results Serum levels of PCT (p = 0.002), IL-6 (p = 0.012), and TNF-α (p = 0.026) in the nano curcumin group on day 10 were significantly lower than in the placebo group. The duration of mechanical ventilation in the nano curcumin group was remarkably (p = 0.038) lower than in the placebo group. Also, the SOFA score significantly (p = 0.005) decreased in the intervention group compared to the placebo group. No significant difference was observed in the mean serum levels of hs-CRP, duration of the intensive care unit stay, and mortality rates between the study groups. Conclusions Our study indicated that nano curcumin could decrease the levels of inflammatory factors, duration of mechanical ventilation, and organ failure in critically ill patients.
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Protocol summary

Study aim
1- Determining and comparing the effect of curcumin supplementation on oxidative indices in patients with systemic inflammatory response syndrome (SIRS). 2- Determining and comparing the effect of curcumin supplementation on inflammatory indicators in patients with SIRS. 3- Determining and comparing the effect of curcumin supplementation on the SOFA index in patients with SIRS
Design
In this study 40 patients aged 18-50 years with systemic inflammatory response syndrome (SIRS positive) are selected in ICU Participants are randomly assigned to RAS software by random block method in one of two groups of curcumin or a control group.
Settings and conduct
After selecting the samples from Imam Reza Tabriz Hospital, the patients are placed in one of two curcumin and control groups. On the first, fifth and tenth day of the study,the SOFA questionnaire, nutritional status will be completed for the patients.Also, 5 cc of blood will be taken from the patients
Participants/Inclusion and exclusion criteria
Inclusions criteria for the study: Critically ill ICU patients with APACHE II score of 15-30; Positive SIRS; Aged over 18 and under the age of 60 years; Hospitalization at least 10 days in ICU; Recipients of enteral nutrition formula; Exclusions criteria: Parenteral feeding; Intolerance to enteral feeding and gavage solution; Patient is waiting for death in the 24 future hourse; HIV positive patient; Pregnant and lactating women; Ileus; Mellitus diabetes; Short bowel syndrome; Pancreatitis; Immune disorders
Intervention groups
The intervention group (two 80 mg capsules) will receive 160 mg / day curcumin The control group will receive the usual formulation without supplementation.
Main outcome variables
1- Assessment of oxidative indices 2- Assessment of inflammatory factors 3. Assessment of SOFA index 4. Assessment of nutrition status 5. Assessment of biochemical factors

General information

Reason for update
Publishing some of the study results and updating the modified factors related to the disease
Acronym
coiss
IRCT registration information
IRCT registration number: IRCT20110123005670N7
Registration date: 2017-12-15, 1396/09/24
Registration timing: prospective

Last update: 2023-08-21, 1402/05/30
Update count: 1
Registration date
2017-12-15, 1396/09/24
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-11-19, 1397/08/28
Actual recruitment end date
2019-08-27, 1398/06/05
Trial completion date
2019-08-27, 1398/06/05
Scientific title
The Effect of curcumin on oxidative indices, inflammatory factors and Sequential Organ Failure Assessment Score in patients with systemic inflammatory response syndrome
Public title
The Effect of curcumin on patients with systemic inflammatory response syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill ICU patients with APACHE II score of 15-30; Positive SIRS; Aged over 18 and under the age of 60 years; Hospitalization at least 10 days in ICU; Recipients of enteral nutrition formula
Exclusion criteria:
Parenteral feeding; Intolerance to enteral feeding and gavage solution; Patient is waiting for death in the 24 future hourse; HIV positive patient; pregnant and lactating women; Ileus; Mellitus diabetes; Short bowel syndrome; Pancreatitis; Immune disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
With Using of RAS software in two groups of 20 people
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golghast Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.TBZMED.REC.1396.762

Health conditions studied

1

Description of health condition studied
Sepsis/At risk of sepsis
ICD-10 code
R65.1
ICD-10 code description
Systemic inflammatory response syndrome (SIRS) of non-infectious origin

Primary outcomes

1

Description
Inflammation
Timepoint
First, fifth, and tenth day
Method of measurement
Interleukin 6 and tumor necrosis factor-alpha, Forkhead box P3, NLR family pyrin domain containing 3, interferon-gamma, and nuclear factor kappa B, high mobility group box 1, Interleukin 8 ,Interleukin 17 and Interleukin 22, Interleukin 10, presepsin, TLR4, ICAM- 1, VCAM-1and PCT

2

Description
Oxidative stress
Timepoint
First, fifth, and tenth day
Method of measurement
Total antioxidant capacity and malondialdehyde, Nrf2,SOD, GPX, BAX, BCL2

3

Description
Sequential Organ Failure Assessment (SOFA)
Timepoint
First, fifth, and tenth day
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Nutrition status
Timepoint
روز1، 5و روز 10
Method of measurement
Received calorie measuring

2

Description
Biochemical factors
Timepoint
روز1، 5و روز 10
Method of measurement
Biochemistry kit

Intervention groups

1

Description
Intervention group: Two curcumin capsules(Sina Pharmaceutical Company) of 80 mg per day for ten days
Category
Treatment - Drugs

2

Description
Control group: Common formulas
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Ata Mahmodpour
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3334 7056
Email
Amahmoodpoor@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Golgasht street, Tabriz University Of Medical Science, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
Tarighata@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Dean for Research and Technology Tabriz University Of Medical Science
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ali Tarighat-Esfanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
TABRIZ
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tarighat esfanjani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
tarighata@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arash Karimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attarneyshabouri street, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 914 300 5895
Email
karimi.ara1990@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable

Trial results

Please tick if results have been published
Yes
Summary result posting date
2023-08-21, 1402/05/30
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2020-04-28, 1399/02/09
Abstract of published paper
Introduction Sepsis is a severe reaction and excessive immune response to infection, which can lead to tissue damage, organ dysfunction, and death. This study aimed to investigate the protective effect of curcumin on inflammatory factors and clinical outcomes in patients with sepsis. Methods This randomized clinical trial was conducted on 40 patients with sepsis aged 18–55 years, who received 160 mg of nano curcumin supplement (two capsules 80 mg) or placebo (two capsules of placebo) via a nasogastric tube for 10 days. Sequential organ failure assessment (SOFA) was evaluated on days 1 and 10. Serum levels of inflammatory factors of procalcitonin (PCT), Interleukin- 6 (IL-6), tumor necrosis factor-alpha, (TNF-α),and high-sensitive C-reactive protein (hs-CRP) were measured before the beginning of the intervention and on days 5 and 10. Length of hospital stay, mortality rate, and mechanical ventilation duration was compared between groups. Results Serum levels of PCT (p = 0.002), IL-6 (p = 0.012), and TNF-α (p = 0.026) in the nano curcumin group on day 10 were significantly lower than in the placebo group. The duration of mechanical ventilation in the nano curcumin group was remarkably (p = 0.038) lower than in the placebo group. Also, the SOFA score significantly (p = 0.005) decreased in the intervention group compared to the placebo group. No significant difference was observed in the mean serum levels of hs-CRP, duration of the intensive care unit stay, and mortality rates between the study groups. Conclusions Our study indicated that nano curcumin could decrease the levels of inflammatory factors, duration of mechanical ventilation, and organ failure in critically ill patients.
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