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The effect of phytosomal curcumin supplementation on severity, frequency, duration of headache and inflammatory factors and oxidative stress in patients with migraine

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History
# Registration date Revision Id
3 2025-06-02, 1404/03/12 342826
2 2021-07-18, 1400/04/27 220794
1 2021-06-23, 1400/04/02 187741
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  • Protocol summary

    Clinical trial, randomized, double-blind, randomized control group of 60 patients. Randomization is done using a valid website and 4-block method.
    Clinical trial, randomized, double-blind, randomized control group of 70 patients. Randomization is done using a valid website and 4-block method.
    کارازمایی بالینی دارای گروه شاهد،دوسویه کور،تصادفی شده است و بر روی 60 نفر است.تصادفی سازی با استفاده از وبسایت معتبر و به روش بلوک بندی ۴ تایی انجام می شود.
    کارازمایی بالینی دارای گروه شاهد،دوسویه کور،تصادفی شده است و بر روی 70 نفر است.تصادفی سازی با استفاده از وبسایت معتبر و به روش بلوک بندی ۴ تایی انجام می شود.
    Before and after the intervention; the severity; duration, and frequency of headache, as well as serum nitric oxide (NO) and total antioxidant capacity (TAC), CRP will be evaluated.
    Before and after the intervention; the severity; duration, and frequency of headache, Sleep quality, as well as serum nitric oxide (NO) and total antioxidant capacity (TAC), TOS, SOD, MDA, CRP will be evaluated.
    قبل و بعد از مداخله، شدت، طول مدت و فرکانس سردرد، همچنین نیتریک اکساید سرم (NO) و ظرفیت تام آنتی اکسیدانی (TAC ) و ، CRP ارزیابی می شوند.
    قبل و بعد از مداخله، شدت، طول مدت و فرکانس سردرد، کیفیت خواب، همچنین نیتریک اکساید سرم (NO) و ظرفیت تام آنتی اکسیدانی (TAC ) و ، CRP، SOD , MDA , TOS ارزیابی می شوند.

  • General information

    60
    70
    Due to the prevalence of Covid 19 disease and the lack of patients with post-traumatic headache and lack of access to curcumin piperine, the title of the project has changed.
    To enhance the statistical power of the study, we propose increasing the sample size to 70 participants and distinguishing between primary and secondary outcomes.
    با توجه به شیوع بیماری کرونا و کمبود بیماران مبتلا به سردرد بعد از تروما و عدم دسترسی به کورکومین پیپرین عنوان طرح تغییر کرده است.
    برای افزایش قدرت آماری مطالعه، پیشنهاد می‌کنیم حجم نمونه به 70 شرکت‌کننده افزایش یابد و برخی متغیرهای اولیه و ثانویه تفکیک شوند

  • Health conditions studied

    #1
    Chronic post-traumatic headache
    Migraine headache
    Post-traumatic headache
    Migraine headache
    سردرد بعد از تروما
    سردرد میگرنی

  • Primary outcomes

    #1
    Nitric oxide
    Quality of life
    نیتریک اکساید
    کیفیت زندگی
    ELISA test
    Questionnaire
    روش الایزا
    پرسش نامه
    #2
    Total antioxidant capacity
    Sleep quality
    ظرفیت تام آنتی اکسیدانی
    کیفیت خواب
    ELISA test
    Sleep quality questionnaire
    روش الایزا
    پرسش نامه کیفیت خواب
    #3
    C-Reactive Protein – CRP
    empty
    پروتئین واکنش پذیر C
    empty
    At baseline and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    ELISA test
    empty
    روش الایزا
    empty

  • Secondary outcomes

    #1
    Quality of Life
    Malondialdehyde (MDA)
    کیفیت زندگی
    مالون دآلدهید
    Quality of life questionnaire
    Calorimetry
    پرسشنامه كيفيت زندگي
    کالریمتری
    #2
    empty
    Superoxide dismutase (SOD)
    empty
    سوپراکسید دیس موتاز
    empty
    At baseline and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Calorimetry
    empty
    کالریمتری
    #3
    empty
    Total oxidant status (TOS)
    empty
    ظرفیت تام اکسدانی
    empty
    At baseline and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Calorimetry
    empty
    کالریمتری
    #4
    empty
    Total Antioxidant Capacity (TAC)
    empty
    ظرفیت تام آنتی اکسیدانی
    empty
    At baseline and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Calorimetry
    empty
    کالریمتری
    #5
    empty
    C reactive protein (CRP)
    empty
    پروتیین واکنشگر C
    empty
    At baseline and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا
    #6
    empty
    Nitric Oxide (NO)
    empty
    نیتریک اکساید
    empty
    At baseline and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Elisa
    empty
    الایزا

Protocol summary

Study aim
Determination of the effect of Phytosomal curcumin supplementation on the severity, frequency, duration of headache and inflammatory factors and oxidative stress on patients with migraine
Design
Clinical trial, randomized, double-blind, randomized control group of 70 patients. Randomization is done using a valid website and 4-block method.
Settings and conduct
This clinical trial will be performed in the clinics of Khorshid Hospital and Al-Zahra Hospital. Phytosomal curcumin and placebo are administered in exactly the same packages to the patient. Patients and researchers will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: completing the consent form; diagnosis of migraine headache by a neurologist. Criteria for non-entry: consumption of anticoagulants such as warfarin, heparin, aspirin, and ...; pregnancy and lactation; follow a special diet in the last 3 months; use of herbal supplements in the last 3 months
Intervention groups
Intervention group: Phytosomal curcumin capsule, containing 250 mg curcumin once a day. Control group: 1 capsule containing 250 mg of maltodextrin.
Main outcome variables
Before and after the intervention; the severity; duration, and frequency of headache, Sleep quality, as well as serum nitric oxide (NO) and total antioxidant capacity (TAC), TOS, SOD, MDA, CRP will be evaluated.

General information

Reason for update
To enhance the statistical power of the study, we propose increasing the sample size to 70 participants and distinguishing between primary and secondary outcomes.
Acronym
IRCT registration information
IRCT registration number: IRCT20201129049534N2
Registration date: 2021-06-23, 1400/04/02
Registration timing: prospective

Last update: 2025-06-03, 1404/03/13
Update count: 2
Registration date
2021-06-23, 1400/04/02
Registrant information
Name
Mohammad bagherniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
bagherniya@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of phytosomal curcumin supplementation on severity, frequency, duration of headache and inflammatory factors and oxidative stress in patients with migraine
Public title
Effect of phytosomal curcumin supplementation on patients with migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who agree to participate in the study and complete the informed consent form. Diagnosis of migraine headache by a neurologist using the third edition of the International Headache Disorders Questionnaire. Age: 18 to 80 years old
Exclusion criteria:
Taking anticoagulants such as warfarin, heparin, aspirin, etc. Pregnancy and lactation Follow a special diet in the last 3 months Use of herbal supplements in the last 3 months
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples generate random numbers using a reputable website: https://www.sealedenvelope.com/simple-randomiser/v1/lists. They are randomly assigned to one of two phytosomal curcumin or placebo supplements.
Blinding (investigator's opinion)
Double blinded
Blinding description
For researchers to be blind, phytosomal curcumin and placebo capsules are purchased equally from Sami labs Ltd., India in shape, colour and size. These capsules are coded by someone other than the researchers (A and B) and the researcher distributes them without knowing the type of capsules. Patients and researchers will not be aware of the capsule-type until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences,Hezar-jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.110

Health conditions studied

1

Description of health condition studied
Migraine headache
ICD-10 code
G44.3
ICD-10 code description
Migraine headache

Primary outcomes

1

Description
Severity of migraine headache
Timepoint
At baseline and end of the study
Method of measurement
VAS scale

2

Description
Frequency of migraine headache
Timepoint
At baseline and end of the study
Method of measurement
Number of migraine headache attacks per month

3

Description
Duration of migraine headache
Timepoint
At baseline and end of the study
Method of measurement
The average duration of migraine headache attacks per hour per headache

4

Description
Quality of life
Timepoint
At baseline and end of the study
Method of measurement
Questionnaire

5

Description
Sleep quality
Timepoint
At baseline and end of the study
Method of measurement
Sleep quality questionnaire

Secondary outcomes

1

Description
Malondialdehyde (MDA)
Timepoint
At baseline and end of the study
Method of measurement
Calorimetry

2

Description
Superoxide dismutase (SOD)
Timepoint
At baseline and end of the study
Method of measurement
Calorimetry

3

Description
Total oxidant status (TOS)
Timepoint
At baseline and end of the study
Method of measurement
Calorimetry

4

Description
Total Antioxidant Capacity (TAC)
Timepoint
At baseline and end of the study
Method of measurement
Calorimetry

5

Description
C reactive protein (CRP)
Timepoint
At baseline and end of the study
Method of measurement
Elisa

6

Description
Nitric Oxide (NO)
Timepoint
At baseline and end of the study
Method of measurement
Elisa

Intervention groups

1

Description
The intervention group will receive a capsule containing Phytosomal curcumin in the amount of 250 mg of curcumin once a day after breakfast for 8 weeks.
Category
Treatment - Drugs

2

Description
The control group will receive capsule (1 capsule) containing a placebo. Each capsule contains 250 mg of maltodextrin for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Mehrnaz shojaei
Street address
Ostandari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir

2

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehrnaz Shojaei
Street address
Soffe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behruz Ataei
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.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
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3972 3138
Email
bagherniya@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-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
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
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.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
Yes - There is a plan to make this available
Title and more details about the data/document
Study information will be published after the individuals are unidentified and after the project is completed.
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further analysis
From where data/document is obtainable
Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir
What processes are involved for a request to access data/document
After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.
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