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General information
Single blinded
Double blinded
singldoubl
1
1
Prevention
Treatment
prevntreat
empty
Regarding the method of blinding the study, after consulting again with the statistical consultant of the project to improve the scientific level of the study, it was decided that the type of randomization method in this two-way trial is blind so that the researcher and patients decide which drug is among the two drugs introduced in The schemes used are uninformed but the clinical caregiver divides and distributes the drugs in similar packages..
Regarding the method of blinding the study, after consulting again with the statistical consultant of the project to improve the scientific level of the study, it was decided that the type of randomization method in this two-way trial is blind so that the researcher and patients decide which drug is among the two drugs introduced in The schemes used are uninformed but the clinical caregiver divides and distributes the drugs in similar packages..
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در مورد نحوه کورسازی مطالعه پس از مشورت مجدد با مشاور آماری پروژه جهت ارتقاء سطح علمی مطالعه تصمیم بر این شد که نوع روش تصادفی سازی در این کارآزمایی دوسویه کور باشد به طوری که محقق و بیماران از اینکه کدام دارو از میان دو داروی معرفی شده در طرح استفاده می شود بی اطلاع هستند بلکه مراقب بالینی داروها را در بسته های مشابه تقسیم بندی و توزیع می کند.
در مورد نحوه کورسازی مطالعه پس از مشورت مجدد با مشاور آماری پروژه جهت ارتقاء سطح علمی مطالعه تصمیم بر این شد که نوع روش تصادفی سازی در این کارآزمایی دوسویه کور باشد به طوری که محقق و بیماران از اینکه کدام دارو از میان دو داروی معرفی شده در طرح استفاده می شود بی اطلاع هستند بلکه مراقب بالینی داروها را در بسته های مشابه تقسیم بندی و توزیع می کند.
One-way blind blinding: Participants' informed consent is taken from the study before starting the study. Participants are divided into two groups according to the random number table method and do not know the type of drug used. Drugs are distributed in similar forms among patients
Randomization by random number table method: After filling the informed consent of the study participants, patients will be divided into two groups by random number table method and will receive and consume one of the two drugs studied in the plan.
One-way blind blindingRandomization by random number table method: Participants'After filling the informed consent is taken fromof the study before starting the study. Participants areparticipants, patients will be divided into two groups according to theby random number table method and do not knowwill receive and consume one of the type of drug used. Drugs are distributedtwo drugs studied in similar forms among patientsthe plan.
کورسازی تک سویه کور : از شرکت کنندگان قبل ازشروع مطالعه رضایتنامه آگاهانه شرکت در مطالعه گرفته می شوند. شرکت کنندگان به روش جدول اعداد تصادفی به دو گروه تقسیم می شوند و از نوع داروی مصرفی اطلاعی ندارند. داروها در اشکال مشابه بین بیماران توزیع می شود
تصادفی سازی به روش جدول اعداد تصادفی: بیماران پس از پر کردن رضایت نامه آگاهانه شرکت در مطالعه، به روش جدول اعدا تصادفی به دو گروه تقسیم بندی می گردند و یکی از دو داروی مورد مطالعه در طرح را دریافت و مصرف خواهند کرد.
کورسازی تک سویه کور تصادفی سازی به روش جدول اعداد تصادفی: بیماران پس از شرکت کنندگان قبل ازشروع مطالعه رضایتنامهپر کردن رضایت نامه آگاهانه شرکت در مطالعه گرفته می شوند. شرکت کنندگان، به روش جدول اعداداعدا تصادفی به دو گروه تقسیم بندی می شوندگردند و یکی از نوعدو داروی مصرفی اطلاعی ندارند. داروهامورد مطالعه در اشکال مشابه بین بیماران توزیع می شودطرح را دریافت و مصرف خواهند کرد.
Patients diagnosed with migraine who meet the inclusion criteria and do not meet the exclusion criteria are divided into two groups based on a random table of numbers. Then patients' written and informed consent to participate in the study is obtained. Take two vitamin C or magnesium oxide supplements that are packed in unspecified packages and are advised to take them daily for two months and to visit them monthly to complete the relevant questionnaire.
Double blind blindness: The clinical researcher and the patients participating in the project are not aware of the type of drug used and only the clinical caregiver, knowing the type of drug, distributes it in similar envelopes. It should be noted that the drugs are similar in dose, color and shape. Also, the envelopes are nameless and recognizable only to the clinical caregiver.
Patients diagnosed with migraine who meetDouble blind blindness: The clinical researcher and the inclusion criteria and do not meet the exclusion criteria are divided into two groups based on a random table of numbers. Then patients' written and informed consent to participate participating in the study is obtainedproject are not aware of the type of drug used and only the clinical caregiver, knowing the type of drug, distributes it in similar envelopes. Take two vitamin C or magnesium oxide supplementsIt should be noted that the drugs are packedsimilar in unspecified packagesdose, color and shape. Also, the envelopes are advisednameless and recognizable only to take them daily for two months and to visit them monthly to complete the relevant questionnaireclinical caregiver.
بیماران با تشخیص میگرن که کرایتریای ورود به مطالعه را داشته و معیارهای خروج را نداشته باشند براساس جدول تصادفی اعداد به دو گروه تقسیم می شوند سپس از بیماران رضایت نامه کتبی و آگاهانه شرکت در مطالعه اخذ می شود آن گاه بیماران براساس تقسیم بندی تصادفی یکی از دو داروی مکمل ویتامین سی یا منیزیوم اکساید را که در پاکت های نامشخص بسته بندی شده دریافت نموده و توصیه به مصرف روزانه آن ها در مدت دو ماه و مراجعه ماهانه جهت تکمیل پرسش نامه های مربوطه می شوند
کورسازی دوسویه کور: محقق بالینی و بیماران شرکت کننده در طرح از نوع داروی مصرفی مطلع نیستند و تنها مراقب بالینی با اطلاع از نوع دارو نسبت به توزیع آن در پاکت های مشابه اقدام می نماید. گفتنی است که دارو ها با دوز ، رنگ و شکل مشابه هستند. همچنین پاکت ها فاقد نام و قابل تشخیص صرفا برای مراقب بالینی می باشند.
کورسازی دوسویه کور: محقق بالینی و بیماران شرکت کننده در طرح از نوع داروی مصرفی مطلع نیستند و تنها مراقب بالینی با تشخیص میگرن که کرایتریای وروداطلاع از نوع دارو نسبت به مطالعه را داشته و معیارهای خروج را نداشته باشند براساس جدول تصادفی اعداد به دو گروه تقسیم می شوند سپس از بیماران رضایت نامه کتبی و آگاهانه شرکت در مطالعه اخذ می شودتوزیع آن گاه بیماران براساس تقسیم بندی تصادفی یکی از دو داروی مکمل ویتامین سی یا منیزیوم اکساید را که در پاکت های نامشخص بسته بندی شده دریافت نمودهمشابه اقدام می نماید. گفتنی است که دارو ها با دوز ، رنگ و توصیه به مصرف روزانه آنشکل مشابه هستند. همچنین پاکت ها در مدت دو ماهفاقد نام و مراجعه ماهانه جهت تکمیل پرسش نامه های مربوطهقابل تشخیص صرفا برای مراقب بالینی می شوندباشند.
Protocol summary
Study aim
prevention
Design
Clinical trial without control group, with parallel groups, single-blind, randomized, 82 patients
Settings and conduct
Location: Hazrat Rasoul Clinic, Shahrekord University of Medical Sciences, Method: 82 patients who met the inclusion criteria and did not meet the exclusion criteria were admitted to the study with consent and were randomly divided into two groups. One group received 250 mg of vitamin C daily for 2 months and the other group received magnesium oxide. The MSQ and Beck Depression Inventory are filled out by patients at the beginning and end of two months. Patients in both groups do not know which medication they are taking.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Their age is between 18 and 60 years.
2. According to ICHD-3 International Community Headache criteria, the diagnosis of migraine should be made by a neurologist at least one year in advance.
3. Diagnosis of moderate to severe migraine
Exclusion criteria
1. Fever or evidence of infection
2. Simultaneous infection with other headaches
3. A history of major depression
4. Daily use of painkillers
5. Pregnancy or pregnancy intention
6. Having chronic diseases
Intervention groups
Group one: 250 mg magnesium oxide tablets once daily orally for 8 weeks
Group 2: Vitamin C supplement tablets of 250 mg once daily orally for 8 weeks
Main outcome variables
The effect of migraine headaches on daily activities based on the MSQ questionnaire
Depression score based on Beck Depression Inventory
General information
Reason for update
Regarding the method of blinding the study, after consulting again with the statistical consultant of the project to improve the scientific level of the study, it was decided that the type of randomization method in this two-way trial is blind so that the researcher and patients decide which drug is among the two drugs introduced in The schemes used are uninformed but the clinical caregiver divides and distributes the drugs in similar packages..
Acronym
IRCT registration information
IRCT registration number:IRCT20201221049787N1
Registration date:2021-01-16, 1399/10/27
Registration timing:prospective
Last update:2021-01-20, 1399/11/01
Update count:1
Registration date
2021-01-16, 1399/10/27
Registrant information
Name
Samira Sourani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3336 4072
Email address
samira.sooraniii95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Magnesium Oxide and Vitamin C Supplementation in Prevention of Migraine Headaches
Public title
Magnesium Oxide and Vitamin C in Migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
According to ICHD-3 standards, the diagnosis of migraine should be made by a neurologist and they should be diagnosed with migraine at least one year before the visit
Diagnosis of moderate to severe migraine (which is the number of headache attacks 2-15 times a month or attacks with less intensity and duration that cause the person to be unable to perform daily tasks
Exclusion criteria:
Fever or evidence of infection
Simultaneous onset of other headaches such as tension headaches, sinusitis, or substance abuse headaches
People with active peptic ulcer and severe gastrointestinal disorders, especially chronic diarrhea
History of kidney failure
History of diabetes
history of major depression
History of asthma and heart disease (conduction block and heart failure)
Daily use of painkillers
Pregnancy or pregnancy intent
Having chronic diseases
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by random number table method: After filling the informed consent of the study participants, patients will be divided into two groups by random number table method and will receive and consume one of the two drugs studied in the plan.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind blindness: The clinical researcher and the patients participating in the project are not aware of the type of drug used and only the clinical caregiver, knowing the type of drug, distributes it in similar envelopes. It should be noted that the drugs are similar in dose, color and shape. Also, the envelopes are nameless and recognizable only to the clinical caregiver.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
No. 1, First Ave., sourani St., Manzarieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815694438
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SKUMS.REC.1398.117
Health conditions studied
1
Description of health condition studied
Common Migraines
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
2
Description of health condition studied
Classic Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura
Primary outcomes
1
Description
The effect of migraine headaches on daily activities
Timepoint
At the beginning of the study and after eight weeks of medication
Method of measurement
MSQ questionnaire
2
Description
Depression score in Beck questionnaire
Timepoint
At the beginning of the study and after eight weeks of medication
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnesium oxide tablets 250 mg once daily orally for 8 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Vitamin C 250 mg tablets once daily orally for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Clinic affiliated to Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Majid Jafari
Street address
Moulavi
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3226 4833
Email
jafarimd90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Majid Shirvani
Street address
Kashani Blvd., the headquarters of the university
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 9508
Email
src@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Samira Sourani
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 1, First Ave., Sourani St., Manzarieh
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815694438
Phone
+98 38 3336 4072
Email
samira.sooraniii95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Majid Jafari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Hajar Hospital., Parastar St
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Email
jafarimd90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Samira Soorani
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 1., First Ave., Sourani St., Manzarieh
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815694438
Phone
+98 38 3336 4072
Email
samira.sooraniii95@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
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