The Effect of Curcumin on Symptoms and Severity of Headache and pro Inflammatory Markers ,Symptoms of Depression ,Anxiety and Stress in Women with Migraine
The effect of curcumin on symptoms and severity of headache and pro inflammatory markers ,symptoms of depression ,anxiety and stress in women with migraine
Design
In this study 44 eligible migraine patients are selected. The participants were randomly assigned to tow groups of intervention and control. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
The present study is a double-blind randomized clinical trial study. Participant and researcher will not be aware of the type of intervention they have been assigned. The subjects in this study will be assigned into tow groups and 22 will be in each groups.patients in the intervention and control groups receive 1000 mg of curcumin or placebo for 8 weeks per day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.Age between 20-50 years old 2. Migraine by the neurologist 3. To participate in the study 4. No symptoms of depression and anxiety and severe stress 5. No anti-oxidant supplementation (vitamin E, vitamin C, selenium, zinc, beta-carotene) and vitamins 6. No tension headaches. 7. No anti-migraine medication. 8. No severe chronic diseases, such as cancer, hepatitis, pancreatitis, diabetes, thyroid disorders, kidney and liver disease
Exclusion criteria: 1. Not willing to participate in the study. 2. Use of antioxidant, vitamin and anti-migraine drugs. 3. Cataracts for chronic diseases and tension headaches. 4. Induce allergic symptoms due to curcumin supplementation. Pregnancy and lactation or any major change in lifestyle or diet
Intervention groups
The intervention group received 2 supplemental curcumin (curcumin 500 mg capsule from Karen Company) for 8 weeks and control subjects received 2 placebo capsules (500 mg corn starch) for 8 weeks.
Main outcome variables
Interleukin-6 - Calcitonin gene-related peptide
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N34
Registration date:2018-08-18, 1397/05/27
Registration timing:retrospective
Last update:2018-08-18, 1397/05/27
Update count:0
Registration date
2018-08-18, 1397/05/27
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
2017-12-30, 1396/10/09
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Curcumin on Symptoms and Severity of Headache and pro Inflammatory Markers ,Symptoms of Depression ,Anxiety and Stress in Women with Migraine
Public title
Effect of Curcumin on Migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 20-50 years
Diagnose of migraine by neurologist
willing to participate on study
Lack of severe depression and anxiety and stress
Not taking Vitamin and Antioxidant supplements (Vitamin E and C ، Selenium ، Zinc and Beta carotene)
Not having tension headaches
Not taking Anti migraine drugs
The absence of severe chronic disease such as Cancer ، Hepatitis ، pancreatitis ، diabetes ، Thyroid disorders ، Kidney and Liver disease
Having no inflammatory diseases or history of heart disease and stroke and taking anti-inflammatory drugs
Exclusion criteria:
Unwilling to participate in the study
Use of antioxidant supplements, vitamins and anti-migraine drugs
Chronic diseases and tension headaches
Indication of allergic symptoms due to curcumin supplementation
Pregnancy and lactation, or any major change in lifestyle or diet
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method was used, randomization unit was used individually and we used statistical software. We assigned each participant to study a code and entered the code into SPSS software. The software selected a random number.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the error from the patient's and researcher's awareness of the type of treatment received and its possible effect on the outcome of the study, we will conduct a double-blind study. Due to the fact that placebo and supplementation of curcumin are completely in the capsule, the participants and the researcher are not aware of the type of supplement they received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اصفهان
Street address
Isfahan University of medical science, Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8135798111
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.mui.rec.1396.2.086
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
G43
Primary outcomes
1
Description
Severity of migraine, migraine frequency and duration of headache
Timepoint
The beginning and the end of the study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Levels of IL-6, CGRP and TAC
Timepoint
The beginning and the end of the study
Method of measurement
Laboratory method
Intervention groups
1
Description
Intervention group: Two oral supplementation curcumin 500 mg are given for 8 weeks.
Category
Other
2
Description
Control group: Two placebo (corn starch) 500 mg for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Khorshid Hospital
Full name of responsible person
Gholamreza Askari
Street address
Isfahan-Governor's Street-Khorshid Hospital
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3626 9719
Fax
+98 31 3626 9719
Email
Askari@mui.ac.ir
Web page address
http://nutr.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir mansor Alavi
Street address
Isfahan-1000 Jerebar-Faculty of Nutrition
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 2776
Fax
+98 31 3792 2776
Email
am.alavi@nutr.mui.ac.ir
Web page address
http://nutr.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
Sheyda Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
اصفهان-چهارباغ 14/5000 Isfahan-Chaharbagh
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3626 9719
Fax
+98 31 3626 9719
Email
sheyda_rezaei@yahoo.com
Web page address
http://nutr.mui.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Amani
Position
Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan-1000 Jerebar-Faculty of Nutrition
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3171
Fax
+98 31 3792 3171
Email
rezaamani@hotmail.com
Web page address
http://nutr.mui.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sheyda rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan-Chaharbagh
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3626 9719
Fax
+98 31 3626 9719
Email
sheyda_rezaei@yahoo.com
Web page address
http://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
A lot of information will be available to people.
When the data will become available and for how long
After printing the article
To whom data/document is available
researchers
Under which criteria data/document could be used
To do similar designs
From where data/document is obtainable
Answer the person
What processes are involved for a request to access data/document