Aim of this study the effect of melatonin on sphincter disorder(urinary symptoms) in multiple sclerosis. This study is clinical trials and three blind with placebo.60 patient with multiple sclerosis with collaboration with the Multiple Sclerosis Society Province select randomly. Inclusion criteria: multiple sclerosis with Mc.donald score; 18 to 50 years; 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 control multiple sclerosis (Interfron) for all patients. We prescribe 3 milligram Melatonin for 8 week in intervention group. We prescribe placebo for 8 week in control group. We use standard questionnaire urodynamic study of urinary disorders. We check patients before and after 8 week by nurologist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022620258N34
Registration date:2017-03-09, 1395/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-09, 1395/12/19
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
2017-06-09, 1396/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of Melatonin on sphincter disorder(urinary symptoms) in multiple sclerosis
Public title
the effect of Melatonin on sphincter disorder in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: multiple sclerosis with Mc.donald score; 18 to 50 years; 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
Both
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)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomize with 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.1394.45
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
urinary disorder
Timepoint
before and after 8 week
Method of measurement
standard questionnaire urodynamic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:We prescribe 3 milligram Melatonin and Interfron for 8 weeks for 30 patients.
Category
Treatment - Drugs
2
Description
Control group:We prescribe placebo and Interfron for 8 weeks for 30 patients.
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
Full name of responsible person
Dr Mohammad Rafiee
Street address
Dr Mohammad Rafiee, Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak University of Medical Sciences