Aim of this study is effect of Melatonin on fatigue in Multiple sclerosis in Valiasr hospital. This study is clinical trials and double blind with placebo.60 patient with multiple sclerosis in collaboration of Multiple sclerosis society province will be selected randomly. Inclusion criteria: multiple sclerosis with Mc.donald score; 18 to 50 years; expanded disability status scale (EDSS) 0 to 5.5.Exclusion criteria: pregnancy; use pulse Corticosteroids drug in 6 months ago; side effect of drug. We prescribe Interfron for controlling multiple sclerosis for all patients. We prescribe 3 milligram Melatonin for 12 weeks in intervention group and placebo for 12 weeks in control group. We use expanded disability status scale (EDSS). We check patients before treatment and 12 weeks after treatment by neurologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072520258N55
Registration date:2017-08-07, 1396/05/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-04-25, 1394/02/05
Expected recruitment end date
2017-08-27, 1396/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Melatonin on the disability of multiple sclerosis patients
Public title
The effect of Melatonin on the disability of multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: multiple sclerosis with Mc.donald score; 18 to 50 years; expanded disability status scale (EDSS) 0 to 5.5
Exclusion criteria: pregnancy; use pulse Corticosteroids drug in 6 months ago; side effect of drug; lack of routine monitoring of patients.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences