The aim of our study is investigation the effects of Pentoxifylline on the recurrence and disease course in relapsing-remitting MS patients in Kerman.
Method and material:
In our double-blinded clinical trial study, using a nonrandomized method of sample selection,44 newly diagnosed MS patients who have had a relapsing-remitting pattern of disease were studied for 18 months. They were divided into 2 groups: group 1, 22 patients received a treatment which included Interferon and oral Pentoxifylline (800 mg daily for 2 months) and group 2 (control group), 22 received Interferon with a placebo. The monthly attack rates and clinical condition of the patients, using the Expanded Disability Status Scale (EDSS), were measured in 3 different times along the study (beginning of the treatment, 6 months after and at the end of the treatment).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301148430N7
Registration date:2014-02-25, 1392/12/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-25, 1392/12/06
Registrant information
Name
Farhad Iranmanesh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 2629
Email address
fpp_farhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Neuroscience Research Center, Kerman University of Medical Sciences
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of Pentoxifylline on reduction of relapse frequency in patients with relapsing-remitting multiple sclerosis (RRMS)
Public title
Effect of pentoxifylline on multiple sclerosis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
new case of MS compatible with MC donalds ؛relapsing -remitting pattern ؛ age between 20-40 Y/O
exclusion criteria:
other patterns of MS except RRMS؛ other immunomodulatory medications use except beta interferon؛pregnancy and lactation ؛concurrent autoimmune diseases and it's related drugs؛allergy to drug ؛liver disease؛renal disease ؛antihypertensive and ASA and anticoagolant drugs
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
RESEARCH AND TECHNOLOGY KERMAN UNIVERSITY OF MEDICAL SCIENCE
Street address
KERMAN,FOURWAY TAHMASABAD
City
KERMAN
Postal code
7619813159
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
k/91/92
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
recurrence
Timepoint
monthly
Method of measurement
clinical examination
2
Description
Expanded Disability Status Scale
Timepoint
before of the treatment, 6 months after and at the end of the treatment
Method of measurement
clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
intervention group :
tablet Pentoxifylline 800 mg daily for 2 months
Category
Treatment - Drugs
2
Description
control group: placebo with similar dose of intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shafa hospital
Full name of responsible person
akbar hamziee moghaddam MD
Street address
kerman,shafa street
City
kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neuroscience Research center
Full name of responsible person
hossien ali ebrahimi MD
Street address
shafah hospital
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neuroscience Research center
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
kerman university of medical science
Full name of responsible person
akbar hamzei moghaddam MD
Position
neuorologist
Other areas of specialty/work
Street address
shafa hospital
City
kerman
Postal code
7618751151
Phone
+98 34121157809
Fax
+98 21 15803
Email
shafahospital@kmu.ac.ir
Web page address
http://shafah.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
kerman university of medical science
Full name of responsible person
rostam seifaddini MD
Position
neurologist
Other areas of specialty/work
Street address
shafa hospital
City
kerman
Postal code
7618751151
Phone
+98 34121157809
Fax
+98 21 15803
Email
shafahospital@kmu.ac.ir
Web page address
http://shafah.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
kerman university of medical science
Full name of responsible person
asma najafzadeh MD
Position
assistant
Other areas of specialty/work
Street address
shafah hospital
City
lerman
Postal code
7618751151
Phone
+98 34121157809
Fax
+98 21 15803
Email
shafahospital@kmu.ac.ir
Web page address
http://shafah.kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)