Evaluation of the effect of administration of melatonin on the frequency and severity of headache in menstrual migraine patients compared with administration of non-steroidal anti-inflammatory drugs
Design
A double-blind, randomized, controlled trial
Settings and conduct
The study was conducted at Imam Khomeini Hospital's neurology clinic on patients with menstrual migraine. The patients were divided into two groups and assigned to one group of naproxen and the other group received melatonin and at the beginning and one month later and three months after the severity And frequency headache were studied. The patients and the person who completed the questionnaire and analyzed the blind.
Participants/Inclusion and exclusion criteria
Women with menstrual migraine who are not pregnant and who are not suffering from other primary headaches and chronic headaches
Intervention groups
Administration of melatonin and its efficacy compared with administration of naproxen and evaluation of the effects of administration of melatonin
Main outcome variables
Effect of Melatonin as Prophylaxis and Study of Complications of Melatonin Administration and Effectiveness in Sleep Disorders in Patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121110011424N4
Registration date:2019-05-08, 1398/02/18
Registration timing:registered_while_recruiting
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Abbas Tafakhori
Name of organization / entity
Iranian Center of Neurological Research
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 0491
Email address
a_tafakhori@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-28, 1397/06/06
Expected recruitment end date
2019-08-28, 1398/06/06
Actual recruitment start date
2018-08-28, 1397/06/06
Actual recruitment end date
2019-08-28, 1398/06/06
Trial completion date
2019-10-23, 1398/08/01
Scientific title
evaluation of melatonin efficacy on frequency and intensity of catamenial migraine headache comparing to naproxen
Public title
Melatonin in catamenial migraine headache compare with naproxen
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women in fertility age with pure catamenial migraine
women in fertility age with migraine headache associated with catamenial headache
Exclusion criteria:
patient with other primary headache
patient with chronic migraine
patient with DM- HTN- peptic ulcer
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
30
Patients with catamenial migraine referred to Neurology Clinic of Imam Khomeini Hospital in 2017
Actual sample size reached:
60
More than 1 sample in each individual
Actual sample size in each individual:
30
Patients with catamenial migraine referred to Neurology Clinic of Imam Khomeini Hospital in 2017
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who had entry criteria were then randomly assigned to two groups by randomly assigned random access to the study type and the consent form for a group of melatonin and for the other naproxen. Patients and prescribing physicians They were unaware and the instructions for how to take the medication were also given to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person filling the questionnaire and analyzing the information and patients were unaware of the form of drug packaging and drug form, but the method of using the drug and other information needed by the person who delivered the drug to patients was explained to them.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ehics committeemee of Tehran University of Medical Science
Street address
Imam khomeini Hospital complex , Bagher khan street
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-02-20, 1396/12/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.4567
Health conditions studied
1
Description of health condition studied
Women with Catamenial migraine headache
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in frequency and severity of headache
Timepoint
baseline,1 month after intervention,3 months after intervention
Method of measurement
migraine diary questionnaire
2
Description
sleep change
Timepoint
baseline,1 month after intervention,3 months after intervention
Method of measurement
Berlin sleep questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: women with catamenial migraine treated with Naproxen
Category
Treatment - Drugs
2
Description
Intervention group: women with catamenial migraine treated with Melatonin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital complex
Full name of responsible person
Abbas tafakhori
Street address
Imam khomeini hospital complex-Bagherkhan street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2424
Fax
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc2.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali sahraiyan
Street address
Tehran university of medical since ,qods street, keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1411713137
Email
info@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
abbas tafakhori
Position
Associated professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
imam khomeinin hospital complex , bagherkhan street , tehran
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2424
Email
abbas.tafakhori@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
abbas tafakhori
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
imam khomeini hospital complex , bagherkhan street , tehran