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The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indicators in patients with ischemic stroke in the rehabilitation phase: a double-blind clinical trial study

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History
# Registration date Revision Id
2 2023-01-05, 1401/10/15 252193
1 2020-12-18, 1399/09/28 163496
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  • Protocol summary

    In this study, 80 patients with a stroke referred to the khorshid Clinic were randomly divided into intervention (Curcumin-piperine 500 mg) and placebo (maltodextrin) according to inclusion and exclusion criteria. , so that the researcher did not know the intervention type in addition to the participants themselves.To double-blind this study, all capsules were coded as A and B prior to study initiation, so that the researcher did not know the intervention type in addition to the participants themselves.
    In this study, 60 patients with a stroke referred to the Imam Moosa Sadr Clinic were randomly divided into intervention (Curcumin-piperine 500 mg) and placebo (maltodextrin) according to inclusion and exclusion criteria. , so the researcher did not know the intervention type in addition to the participants themselves. To double-blind this study, all capsules were coded as A and B prior to study initiation, so that the researcher did not know the intervention type addition to the participants themselves.
    در این مطالعه ۸۰ بیمار مبتلا به سکته مغزی مراجعه کننده به کلینیک خورشید با لحاظ معیارهای ورود و خروج انتخاب و به صورت تصادفی به دو گروه مداخله (کورکومین-پیپرین 500 میلی گرم) و دارونما(مالتودکسترین)تقسیم شدند. برای دوسوکور کردن این تحقیق، قبل از شروع مطالعه همه کپسول ها توسط فردی غیر از پژوهشگر به صورت A و B کدگذاری می شوند.در نتیجه علاوه بر شرکت کنندگان خود فرد پژوهش گر نیز از نوع مداخله اطلاع نداشت.
    در این مطالعه 60 بیمار مبتلا به سکته مغزی مراجعه کننده به کلینیک امام موسی صدر با لحاظ معیارهای ورود و خروج انتخاب و به صورت تصادفی به دو گروه مداخله (کورکومین-پیپرین 500 میلی گرم) و دارونما(مالتودکسترین) تقسیم شدند. برای دوسوکور کردن این تحقیق، قبل از شروع مطالعه همه کپسول ها توسط فردی غیر از پژوهشگر به صورت A و B کدگذاری می شوند.در نتیجه علاوه بر شرکت کنندگان خود فرد پژوهش گر نیز از نوع مداخله اطلاع نداشت.
    Intervention group a daily curcumin-piperine capsule(495 mg curcumin+ 5 mg piperine) and placebo group a daily maltodextrin capsule will receive after meal for 12 weeks.
    Intervention group a daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) and placebo group a daily maltodextrin capsule will receive after meal for 12 weeks.
    گروه مداخله: روزانه یک عدد کپسول کورکومین-پیپرین (495 میلی گرم کورکومین+ 5 میلیگرم پیپرین) و گروه پلاسبو یک عدد کپسول مالتودکسترین بعد از وعده غذایی به مدت 12 هفته دریافت خواهند کرد.
    گروه مداخله: روزانه یک عدد کپسول کورکومین-پیپرین (500 میلی گرم کورکومین+ 5 میلیگرم پیپرین) و گروه پلاسبو یک عدد کپسول مالتودکسترین بعد از وعده غذایی به مدت 12 هفته دریافت خواهند کرد.

  • Intervention groups

    #1
    Intervention group: A daily curcumin-piperine capsule(495 mg curcumin + 5 mg piperine) will receive after meal for 12 weeks.
    Intervention group: A daily curcumin-piperine capsule(500 mg curcumin + 5 mg piperine) will receive after meal for 12 weeks.
    گروه مداخله: گروه مداخله: روزانه یک عدد کپسول کورکومین-پیپرین (495 میلیگرم کورکومین+5 میلیگرم پیپرین)بعد از وعده غذایی به مدت 12 هفته دریافت خواهند کرد.
    گروه مداخله: گروه مداخله: روزانه یک عدد کپسول کورکومین-پیپرین (500 میلیگرم کورکومین+5 میلیگرم پیپرین)بعد از وعده غذایی به مدت 12 هفته دریافت خواهند کرد.
    #2
    Control group: A daily placebo capsule(500 mg maltodextrin) will receive after meal for 12 weeks
    Control group: A daily placebo capsule(505 mg maltodextrin) will receive after meal for 12 weeks
    گروه کنترل: گروه کنترل: روزانه 1عدد کپسول دارونما (500 میلیگرم مالتودکسترین) بعد از وعده غذایی به مدت 12 هفته دریافت خواهند کرد.
    گروه کنترل: گروه کنترل: روزانه 1عدد کپسول دارونما (505 میلیگرم مالتودکسترین) بعد از وعده غذایی به مدت 12 هفته دریافت خواهند کرد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Khorshid clinic
    Name of recruitment center - Persian: کلینیک خورشید
    Full name of responsible person - English: Nimah bahreini
    Full name of responsible person - Persian: نیماه بحرینی
    Street address - English: Isfahan-Governor's Street-Khorshid Hospital
    Street address - Persian: اصفهان-خیابان استانداری-بیمارستان خورشید
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8135798111
    Phone: +98 31 3626 9719
    Fax: +98 31 3626 9719
    Email: bahreini@hlth.mui.ac.ir
    Web page address: http://nutr.mui.ac.ir/
    Name of recruitment center - English: Imam Moosa Sadr Clinic
    Name of recruitment center - Persian: امام موسی صدر
    Full name of responsible person - English: Mohammad Bagherniya
    Full name of responsible person - Persian: محمد باقرنیا
    Street address - English: Imam Moosa Sadr Clinic, Shohada Squre, Isfahan, Iran
    Street address - Persian: اصفهان، میدان شهدا، کلینیک امام موسی صدر
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8135798111
    Phone: +98 31 3626 9719
    Fax: +98 31 3626 9719
    Email: Bagherniya@nutr.mui.ac.ir
    Web page address: http://nutr.mui.ac.ir/

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nimah Bahreini
    Full name of responsible person - Persian: نیماه بحرینی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hezar Jajrib
    Street address - Persian: هزار جریب
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3792 3169
    Mobile: +98 913 304 8537
    Fax: +98 31 3668 1378
    Email: bahreini@hlth.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Bagherniya
    Full name of responsible person - Persian: محمد باقرنیا
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hezar Jajrib
    Street address - Persian: هزار جریب
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3792 3154
    Mobile: +98 913 210 1627
    Fax: +98 31 3668 1378
    Email: Bagherniya@nutr.mui.ac.ir
    Web page address:

Protocol summary

Study aim
The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indicators in patients with ischemic stroke in the rehabilitation phase: a double-blind clinical trial study
Design
Randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
In this study, 60 patients with a stroke referred to the Imam Moosa Sadr Clinic were randomly divided into intervention (Curcumin-piperine 500 mg) and placebo (maltodextrin) according to inclusion and exclusion criteria. , so the researcher did not know the intervention type in addition to the participants themselves. To double-blind this study, all capsules were coded as A and B prior to study initiation, so that the researcher did not know the intervention type addition to the participants themselves.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The person has had a stroke only once, At least 3-6 months have passed since the stroke (sub acute and chronic phase), NIHSS =5-24, diagnosis of stroke by CT-scan and MRI, Age=20-65 years old, BMI=18/5-35, Tendency to participate in the study. Exclusion criteria: Taking anticoagulants such as aspirin, heparin, warfarin, etc. Taking antioxidant and multivitamin supplements and omega-3 supplements.Having malignant diseases and cancers
Intervention groups
Intervention group a daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) and placebo group a daily maltodextrin capsule will receive after meal for 12 weeks.
Main outcome variables
TG; TC; HDL; LDL; Weight; BMI; Waist circumference; Total antioxidant capacity; Fibrinogen; Hs-CRP; BP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N48
Registration date: 2020-12-18, 1399/09/28
Registration timing: prospective

Last update: 2023-01-11, 1401/10/21
Update count: 1
Registration date
2020-12-18, 1399/09/28
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-19, 1399/09/29
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of curcumin-piperine supplementation on inflammatory, oxidative stress and metabolic indicators in patients with ischemic stroke in the rehabilitation phase: a double-blind clinical trial study
Public title
Effect of curcumin-piperine in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The person has had a stroke only once At least 3-6 months have passed since the stroke (subacute and chronic phase) NIHSS =5-24 diagnosis of stroke by CT-scan and MRI Age=20-65 years old BMI=18/5-35 Tendency to participate in the study
Exclusion criteria:
Taking anticoagulants such as aspirin, heparin, warfarin, etc. Taking antioxidant and multivitamin supplements and omega-3 supplements Having malignant diseases and cancers
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Then, within each block, subjects will be randomly assigned to treatment or placebo. Random assignment will be done using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to conduct this research in a double-blind manner, before starting the study, the relevant capsules are coded in A and B by a person other than the researcher, so that the researcher does not know the type of capsules received by both participants and researchers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-18, 1399/08/28
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.593

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction

Primary outcomes

1

Description
HS-CRP
Timepoint
The beginning and the end of the study
Method of measurement
ELISA kit

2

Description
TAC
Timepoint
The beginning and the end of the study
Method of measurement
Laboratory method

3

Description
Fibrinogen plasma level
Timepoint
The beginning and the end of the study
Method of measurement
ELISA kit

4

Description
Lipid profile
Timepoint
The beginning and the end of the study
Method of measurement
Enzymatic method

5

Description
Systolic and diastolic blood pressure
Timepoint
The beginning and the end of the study
Method of measurement
Mercury Barometer

Secondary outcomes

1

Description
Weight
Timepoint
The beginning and the end of the study
Method of measurement
Digital scale

2

Description
Waist Circumference (WC)
Timepoint
The beginning and the end of the study
Method of measurement
Inelastic meters

3

Description
Body mass index (BMI)
Timepoint
The beginning and the end of the study
Method of measurement
Dividing the weight into kilograms by squared height by meter

Intervention groups

1

Description
Intervention group: A daily curcumin-piperine capsule(500 mg curcumin + 5 mg piperine) will receive after meal for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: A daily placebo capsule(505 mg maltodextrin) will receive after meal for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Moosa Sadr Clinic
Full name of responsible person
Mohammad Bagherniya
Street address
Imam Moosa Sadr Clinic, Shohada Squre, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3626 9719
Fax
+98 31 3626 9719
Email
Bagherniya@nutr.mui.ac.ir
Web page address
http://nutr.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://nutr.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
Kosar Boshagh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 6553 9905
Fax
Email
kboshagh71@gmail.com
Web page address
http://nutr.mui.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jajrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3154
Fax
+98 31 3668 1378
Email
Bagherniya@nutr.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kosar Boshagh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 6553 9905
Email
kboshagh71@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The collected deidentified for the primary outcome measure only will be shared
When the data will become available and for how long
12 months after publication
To whom data/document is available
Researchers and academic and research institutes
Under which criteria data/document could be used
To do similar designs
From where data/document is obtainable
Answer the person
What processes are involved for a request to access data/document
The data will be sent to the person after receiving the request and reviewing the request.
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