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 with collaboration of the Multiple Sclerosis Society Province will be selected randomly. Inclusion criteria are including multiple sclerosis with Mc.Donald score; 18 to 50 years; Expanded Disability Status Scale (EDSS) 0 to 5.5; multiple sclerosis with IFN-B. Exclusion criteria: pregnancy; patients with acute attack in 3 months ago; lack of routine monitoring of patients. We prescribe drug for controling multiple sclerosis (Interfron) for all patients. We prescribe 3 milligram Melatonin for 8 weeks in intervention group and placebo for 8 weeks in control group. We use standard fatigue questionnaire (FSS) for fatigue. We check patients before treatment and 8 weeks after treatment by neurologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030120258N35
Registration date:2017-04-27, 1396/02/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-27, 1396/02/07
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 and research, Arak University of Medical Sciences
Expected recruitment start date
2015-06-09, 1394/03/19
Expected recruitment end date
2016-06-08, 1395/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Melatonin on Fatigue in Multiple sclerosis patients
Public title
The effect of Melatonin on Fatigue in 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; multiple sclerosis with IFN-B.
Exclusion criteria: pregnancy; patients with acute attack in 3 months ago; 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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.ARAKMU.REC.1394.51
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Fatigue
Timepoint
before treatment and 8 weeks after treatment
Method of measurement
standard fatigue questionnaire (FSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We prescribe 3 milligram Melatonin every night for 8 weeks.
Category
Treatment - Drugs
2
Description
In control group: We prescribe placebo for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Society Province in Arak
Full name of responsible person
Dr Fardin Faraji
Street address
Shahid Rajaee ,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences