History
# Registration date Revision Id
3 2026-05-18, 1405/02/28 378545
2 2025-04-21, 1404/02/01 355576
1 2023-04-23, 1402/02/03 262414
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  • Protocol summary

    Primary outcomes: Mortality in ICU and 60-days mortality. Secondary outcomes: duration of hospitalization and mechanical ventilation, GCS, APACHE, SOFA, mNUTRIC, CBC, BS, Na, K, Ca, P, Mg, ALT, AST, BUN, Cr, CRP, Blood coagulation tests including PT, PTT, INR.
    Primary outcomes: Mortality in ICU and 30-day and 60-days mortality. Secondary outcomes: duration of hospitalization, stay at ICU, and mechanical ventilation, GCS, APACHE, SOFA, mNUTRIC, CBC, BS, Na, K, ALT, AST, BUN, Cr, CRP, CPK.
    پیامدهای اولیه:مورتالیتی در حین بستری در ICU و مورتالیتی 60 روزه. پیامدهای ثانویه: مدت زمان بستری در بیمارستان و مدت تهویه مکانیکی، مقیاس کمای گلاسکو، اسکورهای APACHE و SOFA و mNUTRIC، آزمایشات شامل شمارش کامل سلولهای خونی، قند خون، سدیم، پتاسیم، کلسیم، فسفر، منیزیم، انزیمهای کبدی، کراتینین و نیتروژن اوره خون، پروتئین واکنشی C، تستهای انعقادی خون شامل PTوPTTو INR.
    پیامدهای اولیه:مورتالیتی در حین بستری در ICU و مورتالیتی 30 و 60 روزه. پیامدهای ثانویه: مدت زمان بستری در بیمارستان و ICU و مدت تهویه مکانیکی، مقیاس کمای گلاسکو، اسکورهای APACHE و SOFA و mNUTRIC، آزمایشات شامل شمارش کامل سلولهای خونی، قند خون، سدیم، پتاسیم، انزیمهای کبدی، کراتینین و نیتروژن اوره خون، پروتئین واکنشی C و کراتین فسفوکیناز.
  • General information

    empty
    To add new outcomes and remove one of the previously recorded laboratory outcome
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    اضافه شدن چند پیامد جدید و حذف یک مورد از پیامدهای ازمایشگاهی قبلی
    Block randomization was done using the block sizes of 3, 6 and 9 with randomization websites (www.sealedenvelope.com). After randomization, the type of treatment is written in A/B/C codes in separate papers and placed in an opaque envelope or the paper will wrap so that no one can see inside the paper (random concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the patient is place in one of the interventions or placebo groups.
    Block randomization was conducted using the block sizes of 3, 6, and 9 with the help of randomization websites (www.sealedenvelope.com). Once A/B/C codes were generated, a list including 327 numbers corresponding to the A/B/C codes will be prepared by a third party and given to the researcher. Someone outside of the research team will pack and label the drugs (from 1 to 327). After obtaining informed consent from eligible participants, one pack of drugs is taken and used accordingly. After completing the data gathering process, each number and its corresponding A/B/C codes will be entered into the software for analysis. Upon completion of the analysis, the A/B/C codes will be decoded.
    تصادفی سازی بلوکی با بلوکهای 3،6 و 9تایی با استفاده از سایتهای اختصاصی راندومیزیشن (www.sealedenvelope.com) صورت خواهد گرفت. کدهای تخصیص داده شده به سه گروه بصورت A و B و Cروی برگه های مجزا به ترتیب نوشته خواهد شد. هر برگه در یک پاکت کدر قرار میگیرد یا برگه ها به گونه ای تا زده و چسب زده میشود که درون ان قابل رویت نباشد (random concealment). پس از اخذ رضایت اگاهانه، با ورود هر بیمار واجدشرایط به ترتیب یک برگه برداشته میشود و طبق کد نوشته شده درون ان، افراد در سه دسته مورد مطالعه جای می گیرند.
    تصادفی سازی بلوکی با بلوکهای 3،6 و 9تایی با استفاده از سایتهای اختصاصی راندومیزیشن (www.sealedenvelope.com) صورت خواهد گرفت و کدهای A و B و C تولید خواهند شد. لیستی متشکل از 327 کد مچ شده با A/B/C توسط فرد ثالثی تهیه و به پژوهشگر تحویل داده میشود. بسته بندی داروها توسط فردی خارج از پژوهش انجام شده و بسته داروها بصورت عددی (1-327) نامگذاری میشود. پس از اخذ رضایت اگاهانه، با ورود هر بیمار واجدشرایط به ترتیب بسته ها برداشته و مصرف میشود. پس از اتمام جمع اوری داده ها، هر عدد با کد A/B/C مچ شده وارد نرم افزار میشود و انالیز انجام خواهدشد. پس از انالیز کدها بازگشایی میشود.
  • Primary outcomes

    #1
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    30-days mortality
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    مرگ و میر 30 روزه
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    Mortality during the 30 days after entering to the study
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    مرگ و میر طی 30 روز از زمان ورود به مطالعه
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    The information will be obtained by phone call.
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    از طریق تماس تلفنی مورتالیتی 30 روزه بررسی خواهد شد.
  • Secondary outcomes

    #1
    Duration of hospitalization will be recorded at the end of the intervention period.
    Duration of hospitalization will be recorded at the end of the study period.
    مدت زمان بستری در انتهای مدت مداخله ثبت میشود.
    مدت زمان بستری در انتهای مدت مطالعه ثبت میشود.
    #2
    Concentration of Calcium (Ca) in the blood
    Liver enzymes including aspartate transaminase (AST) and alanine transaminase (ALT)
    غلظت کلسیم در خون
    آنزیمهای کبدی شامل آسپارتات ترانس آمیناز و آلانین ترانس آمیناز
    #3
    Concentration of Phosphorus (P) in the blood
    Blood urea nitrogen (BUN)
    غلظت فسفر در خون
    نیتروژن اوره خون
    #4
    Concentration of Magnesium (Mg) in the blood
    Creatinine
    غلظت منیزیم در خون
    کراتینین
    #5
    Liver enzymes including aspartate transaminase (AST) and alanine transaminase (ALT)
    C-Reactive Protein (CRP)
    آنزیمهای کبدی شامل آسپارتات ترانس آمیناز و آلانین ترانس آمیناز
    پروتئین واکنشی C
    #6
    Blood urea nitrogen (BUN)
    Length of stay in ICU
    نیتروژن اوره خون
    مدت زمان بستری در ICU
    Before and after the intervention period (7 days)
    Length of stay in ICU will be recorded at the end of the study period.
    قبل و بعد از مدت مداخله (7 روز)
    مدت زمان بستری در ICU در انتهای مطالعه ثبت میشود.
    Blood test
    Observation (record in checklist)
    آزمایش خون
    مشاهده و ثبت در چک لیست
    #7
    Creatinine
    Creatine phosphokinase (CPK)
    کراتینین
    کراتین فسفوکیناز
    #8
    Blood coagulation tests including Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR)
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    تستهای انعقادی خون شامل زمان پروترومبین، زمان نسبی ترومبوپلاستین، نسبت نرمال شده بین المللی
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    Before and after the intervention period (7 days)
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    قبل و بعد از مدت مداخله (7 روز)
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    Blood test
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    آزمایش خون
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    #9
    C-Reactive Protein (CRP)
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    پروتئین واکنشی C
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    Before and after the intervention period (7 days)
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    قبل و بعد از مدت مداخله (7 روز)
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    Blood test
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    آزمایش خون
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  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Bahonar Hospital
    Name of recruitment center - Persian: بیمارستان شهید باهنر
    Full name of responsible person - English: Amirhossein Sahebkar
    Full name of responsible person - Persian: امیرحسین صاحبکار
    Street address - English: School of Pharmacy, University Campus, Azadi square
    Street address - Persian: میدان آزادی، پردیس دانشگاه، دانشکده داروسازی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948954
    Phone: +98 51 3180 1000
    Fax:
    Email: sahebkara@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Shahid Bahonar Hospital
    Name of recruitment center - Persian: بیمارستان شهید باهنر
    Full name of responsible person - English: Narges Ashraf Ganjooei
    Full name of responsible person - Persian: نرگس اشرف گنجوئی
    Street address - English: Shahid Bahonar Hospital, Qaraney Street
    Street address - Persian: خیابان قرنی، بیمارستان شهید باهنر
    City - English: Kerman
    City - Persian: کرمان
    Province: Kerman
    Country: Iran (Islamic Republic of)
    Postal code: 7613747181
    Phone: +98 913 197 0988
    Fax:
    Email: nganjooei@gmail.com
    Web page address:

Protocol summary

Study aim
Investigating the effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma hospitalized in the intensive care unit
Design
Triple-blind parallel randomized clinical trial with control group, phase 2, on 327 patients. We will use the website (www.sealedenvelope.com) for randomization.
Settings and conduct
Traumatic ICU admitted patients in Bahonar hospital in Kerman, with mentioned inclusion criteria, will be enrolled to this study after informed consent. They will be divided into 2 groups of intervention and 1 control group. The duration of intervention will be 7 days and it will be administered by dissolving the powder inside capsule in gavage solution.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Minimum age of 12 years old, ICU admission due to trauma, Sign informed consent by the patients or his first degree relatives, Oral or enteral nutrition (nasogastric or orogastric tube). Exclusion Criteria: Pregnancy or breast feeding, Severe and active bleeding, Re-hospitalization or referral ICU patients from other ICUs, History of obstructive liver disease and biliary disorders, Allergy to Turmeric or products containing Turmeric.
Intervention groups
ّFirst intervention group: Curcumin tablet twice daily (each tablet contain 500 mg Curcumin plus 5mg Piperine) for 7 days made by Sami-Sabinsa Group Limited. Second intervention group: Curcumin tablet once a day (contain 500 mg Curcumin plus 5mg Piperine) plus placebo once a day (for 7 days) made by Sami-Sabinsa Group Limited. Control group: placebo twice daily for 7 days made by Sami-Sabinsa Group Limited.
Main outcome variables
Primary outcomes: Mortality in ICU and 30-day and 60-days mortality. Secondary outcomes: duration of hospitalization, stay at ICU, and mechanical ventilation, GCS, APACHE, SOFA, mNUTRIC, CBC, BS, Na, K, ALT, AST, BUN, Cr, CRP, CPK.

General information

Reason for update
To add new outcomes and remove one of the previously recorded laboratory outcome
Acronym
IRCT registration information
IRCT registration number: IRCT20130829014521N21
Registration date: 2023-04-23, 1402/02/03
Registration timing: registered_while_recruiting

Last update: 2025-09-18, 1404/06/27
Update count: 2
Registration date
2023-04-23, 1402/02/03
Registrant information
Name
Amirhossein Sahebkar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9260
Email address
sahebkara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma hospitalized in the intensive care unit
Public title
The effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age of 12 years old ICU admission due to trauma Sign informed consent by the patients or his first degree relatives Oral or enteral nutrition (nasogastric or orogastric tube)
Exclusion criteria:
Pregnancy or breast feeding Severe and active bleeding Re-hospitalization or referral ICU patients from other ICUs History of obstructive liver disease and biliary disorders Allergy to Turmeric or products containing Turmeric
Age
From 12 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 327
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was conducted using the block sizes of 3, 6, and 9 with the help of randomization websites (www.sealedenvelope.com). Once A/B/C codes were generated, a list including 327 numbers corresponding to the A/B/C codes will be prepared by a third party and given to the researcher. Someone outside of the research team will pack and label the drugs (from 1 to 327). After obtaining informed consent from eligible participants, one pack of drugs is taken and used accordingly. After completing the data gathering process, each number and its corresponding A/B/C codes will be entered into the software for analysis. Upon completion of the analysis, the A/B/C codes will be decoded.
Blinding (investigator's opinion)
Triple blinded
Blinding description
As mentioned before, after randomization, the patients place in three groups of A/B/C and received the products similar in shape and color (blinding of participants). The physician/nurse who will give the products to participants, received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B/C) on datasheets (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Sciences
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.MUMS.REC.1401.403

Health conditions studied

1

Description of health condition studied
Trauma
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Mortality in ICU
Timepoint
During hospitalization in the ICU
Method of measurement
Observation and record in checklist

2

Description
60-days mortality
Timepoint
Mortality during the 60 days after entering to the study
Method of measurement
The information will be obtained by phone call.

3

Description
30-days mortality
Timepoint
Mortality during the 30 days after entering to the study
Method of measurement
The information will be obtained by phone call.

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
Duration of hospitalization will be recorded at the end of the study period.
Method of measurement
Observation (record in checklist)

2

Description
Duration of mechanical ventilation
Timepoint
Duration of mechanical ventilation will be recorded at the end of the intervention period.
Method of measurement
Observation (record in checklist)

3

Description
GCS (Glascow coma scale)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Summing the scores of eye opening, verbal response and motor response.

4

Description
APACHE II(Acute Physiology and Chronic Health Evaluation)
Timepoint
Before and after the intervention (7 days)
Method of measurement
According to scoring system (APACHE is a severity-of-disease classification system that estimates mortality based on a number of laboratory values and patient signs taking both acute and chronic disease into account. This score will be calculated based on the guidelines and recorded in the checklist).

5

Description
SOFA (Sequential Organ Failure Assessment)
Timepoint
Before and after the intervention (7 days)
Method of measurement
According to scoring system (SOFA score is a scoring system that assesses the performance of several organ systems in the body).

6

Description
Modified nutrition risk in critically ill (mNUTRIC) score
Timepoint
Before and after the intervention (7 days)
Method of measurement
According to scoring system (mNUTRIC is used to assess the nutrition risk in critically ill patients. This score estimates the risk according to some variables such as age, the number of comorbidities, hospitalization days, etc. This score will be calculated based on the guidelines and recorded in the checklist).

7

Description
Complete blood count (CBC)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

8

Description
Blood sugar (BS)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

9

Description
Concentration of sodium (Na) in the blood
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

10

Description
Concentration of Potassium (K) in the blood
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

11

Description
Liver enzymes including aspartate transaminase (AST) and alanine transaminase (ALT)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

12

Description
Blood urea nitrogen (BUN)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

13

Description
Creatinine
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

14

Description
C-Reactive Protein (CRP)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

15

Description
Length of stay in ICU
Timepoint
Length of stay in ICU will be recorded at the end of the study period.
Method of measurement
Observation (record in checklist)

16

Description
Creatine phosphokinase (CPK)
Timepoint
Before and after the intervention period (7 days)
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group 1: Curcumin tablet twice daily (each tablet contain 500 mg Curcumin plus 5mg Piperine made by Sami-Sabinsa Group Limited) for 7 days.
Category
Treatment - Drugs

2

Description
Intervention group 2: Curcumin tablet once a day (contain 500 mg Curcumin plus 5mg Piperine made by Sami-Sabinsa Group Limited) plus placebo tablet (made by Sami-Sabinsa Group Limited) once a day for 7 days
Category
Treatment - Drugs

3

Description
Control group: Placebo (microcrystalline cellulose) twice daily (similar to Curcumin tablet in shape, size and color) made by Sami-Sabinsa Group Limited for 7 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Narges Ashraf Ganjooei
Street address
Shahid Bahonar Hospital, Qaraney Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 913 197 0988
Email
nganjooei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amihossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
0098513180110
Email
sahebkara@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
sahebkara@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhossein Sahebkar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, University Campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
sahebkara@mums.ac.ir

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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