Evaluation of Therapeutic and safety of clemastine in symptoms and quality of life in secondry Relapsing MS patients. and Achieving a beneficial, cheap, and less side effect drug.
Design
Clinical trial with control group, double-blind, randomized.The research included a group of 60 people receiving clemastine and group of 60 people receiving placebo.
Settings and conduct
This study is done in the neurology center, baghiatollah clinic,theran,iran.study is double-blind, randomized. The two groups received the drug and placebo for 12 weeks every 12 hours and then responded to the questionnaires.
Participants/Inclusion and exclusion criteria
inclusion criteria:sign informed consent,The patient is not at the same time in another clinical study،The patient is between 18 and 50 years of age. The patient's sex is not important.Exclusion criteria:The pregnant patient can not be selected
Intervention groups
The intervention group contains the drug clemastine fumarate, and the control group is placebo
Main outcome variables
Antibody level changes؛quality of life score؛clinical signs before and after research
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N40
Registration date:2019-09-06, 1398/06/15
Registration timing:retrospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2019-05-19, 1398/02/29
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2019-05-19, 1398/02/29
Trial completion date
2019-05-19, 1398/02/29
Scientific title
Evaluation of Therapeutic and safety of clemastine fumarate in symptoms and quality of life in secondry Relapsing MS patients
Public title
Evaluation of Therapeutic and safety of clemastine fumarate in symptoms and quality of life in secondry Relapsing MS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
inclusion criteria : To sign the consent form knowingly. At the same time,not in another clinical study. The patient is between 18-50 years old. only have a secondery recurrent MS.
Exclusion criteria:
The patient is pregnant
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment to intervention and control group, randomize using, random number
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is done in double bind ways, in which both the researcher and the patient do not know if they received drug or placebo. but it is explained to the patient who is participating in the study and may receive a drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic azad University of medical science
Street address
yasaman alley,yakhchal Street,shariati Street
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
IR.IAU.PS.REC.1397.080
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
quality of life
Timepoint
baseline,three months after the start of intervention
Method of measurement
Questionnaire
2
Description
Symptoms
Timepoint
baseline, three months after the start of intervention
Method of measurement
Examination and diagnostic procedures
Secondary outcomes
1
Description
IgE antibody
Timepoint
baseline and three months after the start intervention
Method of measurement
elisa
2
Description
Brain and Spinal Cord Plaques
Timepoint
baseline and three months after the start of intervention
Method of measurement
MRI
3
Description
IgE antibody
Timepoint
baselines and three months after the start intervention
Method of measurement
elisa
4
Description
IgG antibody
Timepoint
baseline and three months after the start of intervention
Method of measurement
elisa
Intervention groups
1
Description
Intervention group:One milligram pill will take clemastine fumarate every 12 hours for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group:The placebo is taken every 12 hours for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of baghiyatallah hospital
Full name of responsible person
Dr.Yunes Panahi
Street address
Mollasadra street,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
Baghiyatallah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Street address
Mollasadra street,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3253
Email
Baghiyatallah@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Tayyebe zamani
Position
Pharma
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Yakhchal Street, Shariati Street, Gholhak
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
Zamanitayyebe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Yunes Panahi
Position
Ph.D of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Mollasadra street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3250
Email
yunespanahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Tayyebe zamani
Position
Pharm.D
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Mollasadra street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3250
Email
Zamanitayyebe@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the information that is not personal is shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
University researchers
Under which criteria data/document could be used
Other research is to help with this disease
From where data/document is obtainable
zamanitayyebe@gmail.com
What processes are involved for a request to access data/document