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The effect of soy isoflavones supplementation on symptoms of headache and CGRP in women with migraine

Protocol summary

Study aim
The effect of soy isoflavones supplementation on symptoms of headache and CGRP in women with migraine
Design
A randomized controlled clinical trial with parallel groups, double-blind, randomized
Settings and conduct
The target population includes those with migraines referred to the khorshid Clinic and Imam Musa Sadr Clinic,diagnosed according to the criteria of the International Headache Society (HIS) by a neurologist . Split and study for 8 weeks. Before and after the intervention, severity of headache, frequency of headache and duration of headache, serum CGRP level , depression, stress, anxiety and quality of life of migraine patients will be measured.
Participants/Inclusion and exclusion criteria
women,18 years to before menopause,Low risk for both breast and endometrial cancer and no problem in gynecologist breast examination,diagnosis of migraine by a neurologist,Willingness to participate in the study
Intervention groups
Intervention group: One soybean meal per day for eight weeks Control group: One placebo daily with food for eight weeks
Main outcome variables
Symptoms of migraine (severity, frequency, duration of migraine), CGRP level, depression, stress, anxiety, quality of life in migraine patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N44
Registration date: 2020-02-27, 1398/12/08
Registration timing: registered_while_recruiting

Last update: 2020-02-27, 1398/12/08
Update count: 0
Registration date
2020-02-27, 1398/12/08
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
2020-02-20, 1398/12/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of soy isoflavones supplementation on symptoms of headache and CGRP in women with migraine
Public title
The effect of soy isoflavones in migraine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women from the age of 18 to menopause Diagnosis of migraine by a neurologist Willing to work with the project
Exclusion criteria:
With breast cancer and endometrial cancer Problem or risk of breast or endometrial cancer in a breast examination by a gynecologist Having a family history of endometrial and breast cancer OCP medication use
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
The total number of samples randomly will be divided into two groups by random blocks and each group will consist of 44 persons. The blocking method will be used for randomization. To do this, a random allocation sequence will be created through the reputable website https://www.sealedenvelope.com/simple-randomiser/v1/lists.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the supplement and the placebo are similar in appearance and are labeled by a research team member who is not involved in the intervention and evaluation, thus the researcher directly involved in the evaluation and intervention is not aware of the nature of the prescribed supplement and patients are also unaware of the type of supplement they receive.
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
Hezar Jarib
City
esfahan
Province
Isfehan
Postal code
8135798111
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.532

Health conditions studied

1

Description of health condition studied
migraine
ICD-10 code
G43
ICD-10 code description
Migraine

Primary outcomes

1

Description
Migraine symptoms (severity, frequency, duration of migraine)
Timepoint
At baseline and after eight weeks
Method of measurement
Questionnaire

2

Description
Serum levels of calcitonin-associated peptide (CGRP)
Timepoint
At baseline and after eight weeks
Method of measurement
Laboratory analysis (blood test)

Secondary outcomes

1

Description
Depression, stress, anxiety
Timepoint
At baseline and after eight weeks
Method of measurement
DASS-21questionnaire

2

Description
Quality of Life in Migraine Patients
Timepoint
Quality of Life in Migraine Patients
Method of measurement
Migraine –Specific Quality of Life(MSQ)questionnaire

Intervention groups

1

Description
Intervention group: Eat one soybean daily with food for eight weeks
Category
Treatment - Drugs

2

Description
Control group: One placebo (50 mg of starch) daily with food for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorshid clinic
Full name of responsible person
Gholamreza Askari
Street address
Ostandari St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

2

Recruitment center
Name of recruitment center
Imam Musa Sadr Clinic
Full name of responsible person
Gholamreza Askari
Street address
Foroughi St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Gholamreza Askari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
askari@mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
maede babapour golafshani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8317745181
Phone
+98 31 4525 1696
Email
babapour.matiii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maede babapour golafshani
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 31 1792 2110
Email
babapour.matiii@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Major part of information will be available for population.
When the data will become available and for how long
12 months after publication
To whom data/document is available
Available for people working in academic institutions
Under which criteria data/document could be used
To conduct similar studies
From where data/document is obtainable
Dr. Gholamreza Askari askari@mui.ac.ir
What processes are involved for a request to access data/document
The data will send as soon as possible, after receiving the request.
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