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The effect of combined therapy with erythropoetin and methylprednisolone in severe relapse of Multiple Sclerosis patients

Protocol summary

Summary
The aim of the current study is to evaluate the effect of combined therapy of erythropeitin and methylprednisolone in comparison with methylprednisolone and placebo in clinical recovery of acute phase in MS patients. The population of the study is RR-Ms or SP-MS patients in relapse motor. The population of study involved 20 patients which were randomly classified into two groups of ten patients. The patients in group one were under erythropoietin and methylpredisolonle in five consecutive days and the patients in group two were under methylprednisolone and normal saline solution as a placebo. The patients of both groups were followed for EDSS and Ambulatory index after 4, 8 and 12 weeks and after three months, the patients were evaluated in MRI for T2, black hole and contrast enhancing lesions. Method: the current study was interventional, double blind, randomized and control with placebo. Inclusion criteria: definite diagnosis of MS , age between 18 and 45 years, motor force 3/5 or less at presentation Exclusion criteria: pregnancy, breastfeeding, history of diabetes mellitus, hypertension, hyperlipidemia, heavy cigarette smoking, ischemic heart disease, myocardial infarction, cerebrovascular accident The outcome of the study was to evaluate the comparison of EDSS and AI and MRI in two groups of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081914407N1
Registration date: 2013-08-30, 1392/06/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-30, 1392/06/08
Registrant information
Name
Fatemeh Najmi Varzaneh
Name of organization / entity
Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2203 4019
Email address
b-baradaran@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Multiple Sclerosis research center of Sina hospital
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined therapy with erythropoetin and methylprednisolone in severe relapse of Multiple Sclerosis patients
Public title
The effect of erythropoetin on Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: definite diagnosis of MS; age between 18 and 45 years old and motor force 3/5 or less at presentation. Exclusion criteria: pregnancy; brestfeeding; history of diabetes mellitus, hypertension, hyperlipidmia, heavy cigarette smoking, ischemic heart disease, myocardial infarction, cerebovasculaar accident; family history of ischemic heart disease and /or cerebrovascular accident before 45 years; presence of thrombocytosis; presence of polycytemia(hematocrite above 50% in males and above 45% in females); presence of CRF(chronic renal failure); history of any vasculitis or collagen vascular disease; use of contraceptive medication; use of iron substitution; past history of thromboembololic events and any kind of malignancy(treated or untreated).
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Tehran University of Medical Science
Street address
Tehran, Enqelab Sq, Pour sina Ave.
City
Tehran
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
92/d/130/470

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
EDSS
Timepoint
Before intervention, one, two three months after intervention
Method of measurement
Examination

2

Description
Ambulatory Index
Timepoint
Before intervention, one, two three months after intervention
Method of measurement
Examination

3

Description
MRI
Timepoint
Before intervention and three months after intervention
Method of measurement
Visual

Secondary outcomes

1

Description
Blood Pressure
Timepoint
Before intervention, five day and one and three months after intervention
Method of measurement
Sphygmomanometer

2

Description
RBC count
Timepoint
Before intervention, five day and three months after intervention
Method of measurement
Laboratory

Intervention groups

1

Description
In Intervention group, 20000 units IV Erythropoetin and 1000 mg methylprednisoloneIV has been prescribed for five consecutive days.
Category
Treatment - Drugs

2

Description
In control group, Normal saline solution (1000 mg, IV) and methylprednisolone 1000 mg IV has been prescribed for five consecutive days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical science research assistance
Full name of responsible person
Dr. Shahin Akhundzade
Street address
Tehran keshavarz boulvard.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical science research assistance
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Fateme Najmi Varzaneh
Position
Neurology Resident
Other areas of specialty/work
Street address
30 tir, Tehran
City
Tehran
Postal code
Phone
+98 21 6634 8522
Fax
Email
najmi.f87@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Mohammad Ali Sahraian
Position
Associated Professor
Other areas of specialty/work
Street address
30 tir, Tehran
City
Tehran
Postal code
Phone
+98 21 6634 8522
Fax
Email
sahraian1350@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Najmi Varzaneh
Position
Neurology resident
Other areas of specialty/work
Street address
Valiasr street
City
Tehran
Postal code
1966615544
Phone
+98 21 2203 4019
Fax
Email
b-baradaran@student.tums.ac.ir; Najmi.f87@gmail.com; najmi_f83@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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