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The effect of Migraine Cut herbal nasal spray on headache severity and quality of life in patients with migraine

Protocol summary

Study aim
The effect of Migraine Cut herbal nasal spray on headache severity and quality of life in patients with migraine
Design
Clinical trial with control group with parallel groups, phase 2-3 on 80 patients
Settings and conduct
This study is performed in Al-Zahra Hospital in Isfahan. At the beginning of the intervention, the severity of headache and quality of life were measured by a questionnaire. Patients are treated with a migraine cut spray or placebo, and the measurements are repeated after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: newly diagnosed case of migraine, not using migraine medications, age 18 to 60 years, have a minimum literacy rate, satisfaction with participation in this study. Exclusion criteria: pregnancy and lactation, suffering from any chronic physical and mental illness, previous use of migraine prophylaxis, contraindications to anticonvulsant drugs, consumers of anticoagulants, epilepsy, chronic diseases of the gastrointestinal tract
Intervention groups
Intervention group: Patients in this group are routinely treated for migraine prophylaxis, including Depakine 250 mg 1 time per night, and also given a migraine cut nasal spray every 6 hours between 9 am and 9 pm, 2 puffs each time. It is also given in each nasal cavity. At the beginning of the interventions and after 3 months, the severity of headaches and their quality of life will be measured by a questionnaire. Control group: Patients in this group are routinely treated for migraine prophylaxis, including Depakine 250 mg 1 time per night, and they are also given a placebo nasal spray containing sodium chloride, according to the same instructions as the intervention group. At the beginning of the interventions and after 3 months, the severity of headaches and their quality of life will be measured by a questionnaire.
Main outcome variables
Headache severity and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210503051168N1
Registration date: 2021-06-09, 1400/03/19
Registration timing: prospective

Last update: 2021-06-09, 1400/03/19
Update count: 0
Registration date
2021-06-09, 1400/03/19
Registrant information
Name
Ali Fathi jozdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3451 3020
Email address
afg26oct@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Migraine Cut herbal nasal spray on headache severity and quality of life in patients with migraine
Public title
Migraine Cut herbal nasal spray and headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed case of migraine Not using migraine medications Age 18 to 60 years Have a minimum literacy rate Satisfaction with participation in this study
Exclusion criteria:
Pregnancy and lactation Suffering from any chronic physical and mental illness Previous use of migraine prophylaxis Contraindications to anticonvulsant drugs Consumers of anticoagulants Epilepsy Chronic diseases of the gastrointestinal tract
Age
From 18 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-28, 1400/03/07
Ethics committee reference number
IR.MUI.MED.REC.1400.161

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 headache
Timepoint
At the beginning of the intervention and after three months
Method of measurement
Visual Analogue Scale questionnaire

2

Description
Quality of Life
Timepoint
At the beginning of the intervention and after three months
Method of measurement
Migraine Disability Assessment scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group are routinely treated for migraine prophylaxis, including Depakine 250 mg 1 time per night, and also given a migraine cut nasal spray every 6 hours between 9 am and 9 pm, 2 puffs each time. It is also given in each nasal cavity. At the beginning of the interventions and after 3 months, the severity of headaches and their quality of life will be measured by a questionnaire.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group are routinely treated for migraine prophylaxis, including Depakine 250 mg 1 time per night, and they are also given a placebo nasal spray containing sodium chloride, according to the same instructions as the intervention group. At the beginning of the interventions and after 3 months, the severity of headaches and their quality of life will be measured by a questionnaire.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Heliya Hemasian
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
h.hemasian@med.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
No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
haghjoo.sh@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
Heliya Hemasian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
h.hemasian@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Heliya Hemasian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
h.hemasian@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Heliya Hemasian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
h.hemasian@med.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
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.
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