Objectives:The aim of this research is a comparison between Sodium Valproate and Fluoxetine in patient with migraine and chronic fatigue syndrome.
Design:This is a clinical trial and 64 patients with migraine and chronic fatigue syndrome has been studied.They divided into two group with 32 participates randomly.The blinding was not done.The study was in phase 2.
Setting and conduct:Each group separately take the treatment with Sodium Valproate 400mg daily and Fluoxetine 20mg daily.After 8 weeks of treatment,the groups compare with each other by headache intensity score and headache frequency.
Participants including major eligibility criteria: All the patients with migraine whom were examined by neurologist and have chronic fatigue syndrome too.The diagnose of migraine and chronic fatigue syndrome was on the base of ICHD and NICE criteria.
Intervention:A 8 week treatment with Sodium Valproate 400mg daily and Fluoxetine 20mg daily was done.
main outcome measures:The headache intensity score and headache frequency was measured before and after 8 week of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062828680N1
Registration date:2016-07-19, 1395/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-19, 1395/04/29
Registrant information
Name
Mahdis Khazaeli
Name of organization / entity
Esfahan
Country
Iran (Islamic Republic of)
Phone
+98 913 232 9418
Email address
a.rasti@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study between Sodium Valproate and Fluoxetine in patient with migraine and chronic fatigue syndrome
Public title
Comparison between Sodium Valproate and Fluoxetine in patient with migraine and chronic fatigue syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: migraine;chronic fatigue syndrome
Exclusion criteria:The incidence of drug side effects;Individual may not adhere;Individual may not complete follow up
Age
From 20 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Isfahan University of Medical Science
Street address
Isfahan University of Medical Sciences, Isfahan, Hezar Jarib Ave.
City
Isfahan
Postal code
Approval date
2014-01-22, 1392/11/02
Ethics committee reference number
393292
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
intensity score of headache
Timepoint
8 weeks
Method of measurement
VAS score
2
Description
frequency of headache
Timepoint
8 weeks
Method of measurement
headaches attacks per week
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group with Fluoxetine tab 20 mg daily
Category
Treatment - Drugs
2
Description
Intervention group with Sodium Valproat Tan 200 mg BID