Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000353099
Ethics application status
Approved
Date submitted
6/03/2010
Date registered
4/05/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
low dose Aspirin for improving fatigue of multiple sclerosis patients
Scientific title
assessment of effects of low dose aspirin in treatment of fatigue in patients with multiple sclerosis
Secondary ID [1] 1479 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple sclerosis 243616 0
Condition category
Condition code
Neurological 257064 257064 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
tablet aspirin orally 80 mg/day once a day for 8 weeks
Intervention code [1] 256112 0
Treatment: Drugs
Comparator / control treatment
oral tablet microcellulose 80 mg one a day for 8 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 257956 0
fatigue impact scale
Timepoint [1] 257956 0
8 weeks following randomisation
Primary outcome [2] 257957 0
depression(Beck 2 score)
Timepoint [2] 257957 0
8 weeks following randomisation
Secondary outcome [1] 263484 0
nil
Timepoint [1] 263484 0
nil

Eligibility
Key inclusion criteria
-known cases of relapsing-remitting ,secondary progressive,primary progressive Multiple sclerosis
-ability to walk at least 100 meters without help
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-co-existence of cardiac, respiratory, metabolic disease
-exacerbation of disease in the recent month
-consuming drugs affecting neurological system in 2 weeks before start point
-major depression

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 1968 0
Iran, Islamic Republic Of
State/province [1] 1968 0
tehran

Funding & Sponsors
Funding source category [1] 256608 0
Commercial sector/Industry
Name [1] 256608 0
cinnagen company
Country [1] 256608 0
Iran, Islamic Republic Of
Funding source category [2] 256627 0
University
Name [2] 256627 0
shahed
Country [2] 256627 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
nabavi ,seyed masoud
Address
Mostafa Khomeini Hospital
Vesal St., Italia St.
Tehran
Iran
Postal/ZIP 141665185
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 255915 0
None
Name [1] 255915 0
Address [1] 255915 0
Country [1] 255915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258638 0
ethics committee of shahed university
Ethics committee address [1] 258638 0
Shahed University
Opposite Holy Shrine of Imam Khomeini
Kalij Fars Expressway
Tehran
Iran
Postal/ZIP 3319118651
Ethics committee country [1] 258638 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 258638 0
Approval date [1] 258638 0
Ethics approval number [1] 258638 0

Summary
Brief summary
Multiple sclerosis (MS) is one of disabling diseases in young’s . Fatigue is one of the most common complications of multiple sclerosis, reported in 70 to 100 percent of patients. Pathophysiology of this symptom has not fully understood in this disease, yet.
Aspirin (1300mg/daily) was used for relieving this complication for the first time by Wingerchuk,D.M(2005) and reported to had statistically meaningful comparing placebo. But high dose aspirin has multiple gastrointestinal and cardiovascular complications, limiting its use.
In this study low dose aspirin (80mg/daily) will be compared with placebo in treatment of fatigue in 110 MS patients in hope to reduce high dose aspirin complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30105 0
Address 30105 0
Country 30105 0
Phone 30105 0
Fax 30105 0
Email 30105 0
Contact person for public queries
Name 13352 0
pourfarzam, shahryar
Address 13352 0
Mostafa Khomeini Hospital
Vesal St., Italia St.
Tehran
Iran
Postal/ZIP 141665185
Country 13352 0
Iran, Islamic Republic Of
Phone 13352 0
+982188963122
Fax 13352 0
+982188963122
Email 13352 0
[email protected]
Contact person for scientific queries
Name 4280 0
Nabavi, seyed masoud
Address 4280 0
Mostafa Khomeini Hospital
Vesal St., Italia St.
Tehran
Iran
Postal/ZIP 141665185
Country 4280 0
Iran, Islamic Republic Of
Phone 4280 0
+982188963122
Fax 4280 0
Email 4280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLow dose aspirin for MS-related fatigue: Results of a pilot, double-blind, randomized trial.2017https://dx.doi.org/10.1016/j.npbr.2016.11.002
N.B. These documents automatically identified may not have been verified by the study sponsor.