comparing the efficacy of IV methyprednisolone plus oral prednisolone therapy with IV methyprednisolone therapy alone in the treatment of acute demyelinating optic neuritis
study purpose:comparing the efficacy of IV methyprednisolone plus oral prednisolone therapy with IV methyprednisolone therapy alone in the treatment of acute demyelinating optic neuritis
study design:randomized,double blind,control with placebo,single central,stage 2 of trial,
inclusion criteria:patient 15 to 50 years old reffered with opti neuritis" that their visual acuity decreased above 50%.
exclusion criteria:side effect such as gastrointestinal bleeding...during usage of methyprednisolone puls and oral prednisolone" patients with diabets
sample number:60
intervention: oral prednisolone usage inintervention group and placobo in control group.
intervention time:10 days.
study effect:recovery of visual acuity and color vision
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102724734N1
Registration date:2016-04-18, 1395/01/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-18, 1395/01/30
Registrant information
Name
Adel Nejati khoshkbejari
Name of organization / entity
Ahvaz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 4564
Email address
nejati.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-11-20, 1394/08/29
Expected recruitment end date
2016-02-17, 1394/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the efficacy of IV methyprednisolone plus oral prednisolone therapy with IV methyprednisolone therapy alone in the treatment of acute demyelinating optic neuritis
Public title
prednisolone effect in optic neutitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patient 15 to 50 years old reffered with optic neuritis" that their visual acuity decreased above 50%
Exclusion criteria:side effect such as gastrointestinal bleeding ,...during usage of methyprednisolone puls and oral prednisolone" patients with diabet
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
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
randomized desin:blocking
Secondary Ids
1
Registry name
no registry anywhere
Secondary trial Id
-
Registration date
empty
2
Registry name
در جایی ثبت نشده است
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur university of Medical Sciences
Street address
Central organization,Ahvaz Jundishapur university of Medical Sciences ,golestan bolvar,Ahvaz,khoozestan
City
ahvaz
Postal code
Approval date
2015-05-30, 1394/03/09
Ethics committee reference number
ir.ajums.rec.1394.179
Health conditions studied
1
Description of health condition studied
optic neuritis
ICD-10 code
g35-g37
ICD-10 code description
demyelinating diseases of the central nervous system
Primary outcomes
1
Description
visual acuity
Timepoint
before.first day after end of intervention, 1month.3months afte intervention
Method of measurement
snellen chart
Secondary outcomes
1
Description
color vision
Timepoint
before,first day after end of intervention ,1month,3months after intervention
Method of measurement
farnsworth d15
Intervention groups
1
Description
intervention group:Tab prednisolone 50 mg po for 10 days,Made by:Abureihan pharmacy
Category
Treatment - Drugs
2
Description
control group:Tab placebo po daily for 10 days,Made by: Jondishapur Ahvaz University of Pharmacy Sciences
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Seyed Ehsan Mohammadyani nejad-assistant professor of neurology