Aim of this study is effects of Melatonin on radiological changes of multiple sclerosis patient. This study is clinical trials and double blind with placebo.60 patient with multiple sclerosis with collaboration of the 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;lack of routine monitoring of patients; attack during the study; antioxidant use in the last 3 months. We prescribe drug for controling multiple sclerosis (Interfron) for all patients. We prescribe 3 milligram Melatonin for 12 weeks in intervention group and placebo for 12 weeks in control group. We check patients with MRI from the point of view T1,T2, GAD Plaques in start of study and 3 months after treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017072520258N56
Registration date:2017-07-26, 1396/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-26, 1396/05/04
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
2015-04-26, 1394/02/06
Expected recruitment end date
2017-08-28, 1396/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Melatonin on radiological changes of multiple sclerosis patient
Public title
Effects of Melatonin on radiological changes of multiple sclerosis patient
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;lack of routine monitoring of patients; attack during the study; Antioxidant use in the last 3 months
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