The effect of cinnamon consumption on symptoms, severity of headache, inflammatory markers and anthropomethric indices among patients with migraine headache
The effect of cinnamon consumption on symptoms, severity of headache, inflammatory markers and anthropomethric indices among patients with migraine headache
Design
In this study 44 eligible migraine patients will be selected. The participants will randomly be distributed based on the permuted block randomization method into two intervention and control group. Random assignment in each block will be done by the table of random numbers. Group allocation will be concealed by assigning a unique code to each participant.
Settings and conduct
This is a double-blind randomized clinical trial study. The study will be conducted at KHorshid and Imam Moosa Sadr clinics in Isfahan. Participant and researcher will not be aware of the type of intervention group they will be assigned. The subjects in this study will be assigned into two groups and 22 subjects will be in each groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People aged 20-50 years old; Diagnose of migraine by a neurologist; willing to participate in the study.
Non-inclusion criteria: Pregnancy and breastfeeding; Menopause; consumption of antioxidants and cinnamon supplements; history of cinnamon sensitivity and allergy; having tension headaches; chronic diseases such as chronic kidney diseases, gastrointestinal diseases and Alzheimer's
Intervention groups
Intervention group: Three capsules each containing 600 mg of cinnamon powder will be taken after each main meal for 8 weeks. Control group: Three placebo capsules each containing 600 mg of corn starch will be taken after each main meal for 8 weeks.
Main outcome variables
Severity of migraine attacks; Frequency of migraine attacks; Duration of migraine attacks; Migraine Disability Assessment Questioner (MIDAS); Inflammatory factors:IL6 and CGRP; Weight; Waist circumference; waist to hip ratio (WHR); body mass index (BMI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N36
Registration date:2019-01-25, 1397/11/05
Registration timing:retrospective
Last update:2019-01-25, 1397/11/05
Update count:0
Registration date
2019-01-25, 1397/11/05
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
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-09-08, 1397/06/17
Actual recruitment end date
2018-11-14, 1397/08/23
Trial completion date
2019-01-13, 1397/10/23
Scientific title
The effect of cinnamon consumption on symptoms, severity of headache, inflammatory markers and anthropomethric indices among patients with migraine headache
Public title
Cinnamon, Inflammatory markers and anthropometric indices in patients with Migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 20-50 years old
Diagnose of migraine by a neurologist
willing to participate in the study
Exclusion criteria:
Pregnancy and breastfeeding
Menopause
consumption of antioxidants and cinnamon supplements
history of cinnamon sensitivity and allergy
having tension headaches
having chronic diseases such as chronic kidney diseases, gastrointestinal diseases and Alzheimer's
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects. Subjects will be assigned to blocks, based on gender. 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
This is a double-blind clinical trial (participant, researcher) study. The cinnamon capsules and placebo will be produced by Faculty of Pharmacy, Isfahan University of Medical Sciences. Cinnamon capsules and placebo will be in the package with the same shape and color and the patients and researcher will not aware of the content of the pack until the end of the trial.
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
Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-09-02, 1397/06/11
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.185
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura
2
Description of health condition studied
Migraine
ICD-10 code
G43.1
ICD-10 code description
Migraine with aura
Primary outcomes
1
Description
Severity of migraine attacks
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
VAS scale
2
Description
Frequency of migraine attacks
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
Questionnaire
3
Description
Duration of migraine attacks
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
Questionnaire
4
Description
Migraine Disability Assessment Questioner (MIDAS)
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Interleukin 6 (IL6)
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)
2
Description
Calcitonin Gene-Related Peptide (CGRP)
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)
3
Description
weight
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
Mechanical scales
4
Description
Waist Circumference
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
non-stretching tape measure
5
Description
Waist / hip ratio - WHR
Timepoint
Before the start of the study and 8 weeks after the intervention
Method of measurement
non-stretching tape measure
6
Description
Body Mass Index
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Dividing the weight into kilograms by squared height by meter
Intervention groups
1
Description
The Intervention group will receive three capsules each containing 600 mg of cinnamon powder after each 3 main meals per day for 8 weeks. Cinnamon capsule will be manufactured by Faculty of Pharmacy, Isfahan University of Medical Sciences.
Category
Treatment - Other
2
Description
The control group will receive three placebo capsules (600 mg of corn starch) after each 3 main meals for 8 weeks.The placebo will be manufactured by Faculty of Pharmacy, Isfahan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid clinic
Full name of responsible person
Dr. Gholamreza Askari
Street address
Ostandari Ave.
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
Dr. Gholamreza Askari
Street address
Foroghi Ave.
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 haghjou
Street address
Hezarjarib Ave., Isfahan University of Medical Sciences
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?
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
Azadeh Zareie
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
a_z.zarei@yahoo.com
Person responsible for scientific 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 updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azadeh zareie
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Hezarjarib Ave., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2110
Email
a_z.zarei@yahoo.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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Major part of informations will be available for population.
When the data will become available and for how long
starting 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 via email: 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.