The effect of black grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine
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Protocol summary
Inclusion criteria: patients who are willing to participate in the study, diagnosed with migraine by a neurologist and according to the criteria of the International Classification of Headache Disorders-3 (ICHD-3), age 18 to 60 years, having at least one migraine attack per month, body mass index between 18.5 to 30.
Non-inclusion criteria: suffering from tension-type headaches, suffering from chronic kidney diseases, cancer, and other neurological disorders, change in the type of medicine used and its dosage during the last month, pregnancy, and lactation, taking supplements containing antioxidants and black grape seed extract in the past 3 months, following a special diet
Inclusion criteria: willingness to participate in the study, diagnosed with migraine by a neurologist and according to the criteria of the International Classification of Headache Disorders-3 (ICHD-3), age 18 to 60 years, having at least one migraine attack per month, body mass index between 18.5 to 30.
Non-inclusion criteria: suffering from tension-type headaches, chronic kidney diseases, cancer, and other neurological disorders, change in type and dosage of medications in the past month, taking supplements containing antioxidants and black grape seed extract in the past 3 months, following a special diet, pregnancy, and lactation.
Inclusion criteria: patients who are willingwillingness to participate in the study, diagnosed with migraine by a neurologist and according to the criteria of the International Classification of Headache Disorders-3 (ICHD-3), age 18 to 60 years, having at least one migraine attack per month, body mass index between 18.5 to 30. Non-inclusion criteria: suffering from tension-type headaches, suffering from chronic kidney diseases, cancer, and other neurological disorders, change in the type and dosage of medicine used and its dosage duringmedications in the lastpast month, pregnancy, and lactation, taking supplements containing antioxidants and black grape seed extract in the past 3 months, following a special diet, pregnancy, and lactation.
شرایط ورود: بیمارانی که تمایل به شرکت در مطالعه داشته باشند، تشخیص ابتلا به میگرن توسط متخصص مغز و اعصاب و بر اساس معیار های طبقه بندی بین المللی اختلالات سردرد (ICHD-3:International Classification of Headache Disorders-3)، سن 18 تا 60 سال، داشتن حداقل یک حمله میگرنی در ماه، نمایه توده بدنی بین 18.5 تا 30.
معیار های عدم ورود: ابتلا به سردرد های تنشی، ابتلا به بیماری های مزمن کلیوی، سرطان و سایر اختلالات عصبی، تغییر نوع داروی مصرفی و دوز آن طی یک ماه گذشته، بارداری و شیردهی، مصرف مکمل های حاوی آنتی اکسیدان و عصاره هسته انگور سیاه در 3 ماه گذشته، پیروی از رژیم غذایی خاص
معیار های ورود: تمایل به شرکت در مطالعه، تشخیص ابتلا به میگرن توسط متخصص مغز و اعصاب و بر اساس معیار های طبقه بندی بین المللی اختلالات سردرد (ICHD-3:International Classification of Headache Disorders-3)، سن 18 تا 60 سال، داشتن حداقل یک حمله میگرنی در ماه، نمایه توده بدنی بین 18.5 تا 30.
معیار های عدم ورود: ابتلا به سردرد های تنشی، بیماری های مزمن کلیوی، سرطان و سایر اختلالات عصبی، تغییر در نوع و دوز دارو های مصرفی در ماه گذشته، مصرف مکمل های حاوی آنتی اکسیدان و عصاره هسته انگور سیاه در 3 ماه گذشته، پیروی از رژیم غذایی خاص، بارداری و شیردهی.
شرایطمعیار های ورود: بیمارانی که تمایل به شرکت در مطالعه داشته باشند، تشخیص ابتلا به میگرن توسط متخصص مغز و اعصاب و بر اساس معیار های طبقه بندی بین المللی اختلالات سردرد (ICHD-3:International Classification of Headache Disorders-3)، سن 18 تا 60 سال، داشتن حداقل یک حمله میگرنی در ماه، نمایه توده بدنی بین 18.5 تا 30. معیار های عدم ورود: ابتلا به سردرد های تنشی، ابتلا به بیماری های مزمن کلیوی، سرطان و سایر اختلالات عصبی، تغییر در نوع داروی مصرفی و دوز آن طی یکدارو های مصرفی در ماه گذشته، بارداری و شیردهی، مصرف مکمل های حاوی آنتی اکسیدان و عصاره هسته انگور سیاه در 3 ماه گذشته، پیروی از رژیم غذایی خاص، بارداری و شیردهی.
Intervention group: Daily two capsules containing black grape seed extract (Daru Pajhuh-e-Jaber company) for eight weeks. Control group: Two placebo capsules per day (Daru Pajhuh-e-Jaber company) for eight weeks.
Intervention group: Daily two capsules containing black grape seed extract for eight weeks. Control group: Two placebo capsules per day for eight weeks.
Intervention group: Daily two capsules containing black grape seed extract (Daru Pajhuh-e-Jaber company) for eight weeks. Control group: Two placebo capsules per day (Daru Pajhuh-e-Jaber company) for eight weeks.
گروه مداخله: روزانه دو عدد کپسول حاوی عصاره هسته انگور سیاه (شرکت دارو پژوه جابر) به مدت هشت هفته. گروه کنترل: روزانه دو عدد کپسول دارونما (شرکت دارو پژوه جابر) به مدت هشت هفته
گروه مداخله: روزانه دو عدد کپسول حاوی عصاره هسته انگور سیاه به مدت هشت هفته. گروه کنترل: روزانه دو عدد کپسول دارونما به مدت هشت هفته
گروه مداخله: روزانه دو عدد کپسول حاوی عصاره هسته انگور سیاه (شرکت دارو پژوه جابر) به مدت هشت هفته. گروه کنترل: روزانه دو عدد کپسول دارونما (شرکت دارو پژوه جابر) به مدت هشت هفته
Migraine symptoms, patients' quality of life, calcitonin gene-related peptide, vascular cell adhesion molecule-1, oxidative stress status
Migraine symptoms, migraine disability, calcitonin gene-related peptide, vascular cell adhesion molecule-1, total antioxidant capacity, and malondialdehyde
علائم میگرن، کیفیت زندگی بیماران، پپتید مرتبط با ژن کلسی تونین، مولکول چسبنده سلول عروق-1، وضعیت استرس اکسیداتیو
علائم میگرن، ناتوانی ناشی از میگرن، پپتید مرتبط با ژن کلسی تونین، مولکول چسبنده سلول عروق-1، ظرفیت تام آنتی اکسیدانی و مالون دی آلدهید
علائم میگرن، کیفیت زندگی بیمارانناتوانی ناشی از میگرن، پپتید مرتبط با ژن کلسی تونین، مولکول چسبنده سلول عروق-1، وضعیت استرس اکسیداتیوظرفیت تام آنتی اکسیدانی و مالون دی آلدهید
General information
An update was made in the inclusion and non-inclusion criteria. Because they were very restrictive
Correction of main outcome variables in the protocol abstract.
An update was madeCorrection of main outcome variables in the inclusion and non-inclusion criteriaprotocol abstract. Because they were very restrictive
به روز رسانی در معیار های ورود به مطالعه و عدم ورود به مطالعه انجام شد. زیرا بسیار محدود کننده بودند.
تصحیح متغیر های پیامد اصلی در چکیده پروتکل.
به روز رسانیتصحیح متغیر های پیامد اصلی در معیار های ورود به مطالعه و عدم ورود به مطالعه انجام شدچکیده پروتکل. زیرا بسیار محدود کننده بودند.
Primary outcomes
#1
Migraine-induced disability
Migraine disability
Migraine-induced disability
Protocol summary
Study aim
The effect of black grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine
Design
A randomized controlled clinical trial with parallel groups, double-blind, on 50 patients. Stratified randomization based on migraine type and body mass index
Settings and conduct
Migraine patients will be selected from the patients referred to the neurology clinic of Khorshid Hospital in Isfahan City. Then the patients will be divided into two intervention (black grape seed extract) and control (placebo) groups. The duration of the intervention will be eight weeks. Anthropometric measures and biochemical factors will be assessed at the baseline and end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study, diagnosed with migraine by a neurologist and according to the criteria of the International Classification of Headache Disorders-3 (ICHD-3), age 18 to 60 years, having at least one migraine attack per month, body mass index between 18.5 to 30.
Non-inclusion criteria: suffering from tension-type headaches, chronic kidney diseases, cancer, and other neurological disorders, change in type and dosage of medications in the past month, taking supplements containing antioxidants and black grape seed extract in the past 3 months, following a special diet, pregnancy, and lactation.
Intervention groups
Intervention group: Daily two capsules containing black grape seed extract for eight weeks. Control group: Two placebo capsules per day for eight weeks.
Main outcome variables
Migraine symptoms, migraine disability, calcitonin gene-related peptide, vascular cell adhesion molecule-1, total antioxidant capacity, and malondialdehyde
General information
Reason for update
Correction of main outcome variables in the protocol abstract.
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N56
Registration date:2023-03-26, 1402/01/06
Registration timing:prospective
Last update:2024-01-02, 1402/10/12
Update count:2
Registration date
2023-03-26, 1402/01/06
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
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of black grape seed extract supplementation on inflammatory biomarkers, oxidative stress, clinical symptoms, and quality of life in patients with migraine
Public title
The effect of black grape seed extract supplement in patients with migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are willing to participate in the study
Migraine diagnosis by a neurologist based on the International Classification of Headache Disorders-3 (ICHD-3)
Age 18 to 60 years
Having at least one migraine attack per month
Body mass index between 18.5 to 30
Exclusion criteria:
Suffering from chronic kidney diseases, cancer, and other neurological disorders
Suffering from tension-type headaches
Change in the type of medicine used and its dosage during the last month
Pregnancy and lactation
Taking supplements containing antioxidants and black grape seed extract in the last 3 months
Following a special diet
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done based on the stratified randomization method. To distribute patients into intervention and control groups, first, persons are classified into four states according to the type of migraine (with aura/without aura) and body mass index (18.5 to 24.9 and 25 to 30). Then, persons with the same conditions will be randomly assigned to two intervention and control groups. For this purpose, the first person who referred will be in the intervention group and the other person with the same conditions will be in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial study (participant, outcome assessor). The black grape seed extract supplement and its placebo (identical in terms of color, shape, and taste) will be packaged in similar boxes, and the participants and the outcome assessor will not be informed of the contents of the packages 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 of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.405
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Severity of migraine attacks
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Migraine disability
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Blood test (ELISA)
5
Description
Malondialdehyde (MDA) serum level
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Blood test (colorimetric method)
6
Description
Serum level of total antioxidant capacity (TAC)
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Blood test (colorimetric method)
7
Description
Migraine frequency
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Question / Number of attacks per month
8
Description
Duration of migraine headache
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Question/ average duration of migraine attacks per headache (hours)
Secondary outcomes
1
Description
Quality of life in migraine patients
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Migraine-Specific Quality of Life (MSQ)
2
Description
Depression
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Depression Anxiety and Stress Scale-21 questionnaire (DASS-21)
3
Description
Anxiety
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Depression Anxiety and Stress Scale-21 questionnaire (DASS-21)
4
Description
Stress
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Depression Anxiety and Stress Scale-21 questionnaire (DASS-21)
5
Description
Blood pressure
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
Mercury barometer
6
Description
Anthropometric indices
Timepoint
Before the start of the intervention and 60 days after the start of the intervention
Method of measurement
A digital scale and standard stadiometer
Intervention groups
1
Description
Intervention group: Two capsules of black grape seed extract daily (containing 100 mg of black grape seed extract, Daru Pajhuh-e-Jaber company) for eight weeks
Category
Treatment - Drugs
2
Description
Control group: Two placebo capsules daily (containing calcium phosphate, Avicel, and gelatin, Daru Pajhuh-e-Jaber company) for eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology clinic of Khorshid hospital
Full name of responsible person
Dr. Gholamreza Askari
Street address
khorshid medical educational research complex, Ostandari Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145833117
Phone
+98 31 3222 2127
Email
Askari@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Web page address
https://research.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
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Web page address
https://research.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.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