Multiple sclerosis is a demyelinating disease of central nervous system. Cognitive impairment is one of important disorder in these patients that have prevalence about 34-65%. Boswellia serrata is a substance that has been used for the augmentation of memory and learning skills in the past. There are plenty of studies focusing on the anti-inflammatory effects of Boswellia serrata. In addition of anti-inflammatory effects, neuroprotective properties have been reported. Since MS is an inflammatory disease and cognitive impairment is one of the influential elements on the life of MS patients, the effect of Boswellia serrata on the cognitive impairment of MS patients is investigated in the present work using BICAMS test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070813911N1
Registration date:2013-08-22, 1392/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-22, 1392/05/31
Registrant information
Name
Behnaz Sedighi
Name of organization / entity
Kerman University of Medical Sciences, Shafa hospital
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5817
Email address
b-sedighi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Neurology Research Center,Kerman University of Medical Sciensec, Kerman, Iran
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparesion between treatment with Bosweilia serrata against placebo to change the progression of cognitive disorders in Multiple sclerosis patients
Public title
Effect of Bosweilia serrata in prevention of cognitive impairment progression in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: definite multiple sclerosis.
Exclusion criteria: taking new drugs; hypersensitivity to Bosweilia serrata and drug side effect.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
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
Neurology Research Center,Kerman University of Medical Sciensec, Kerman, Iran
Street address
shafa hospital,kerman
City
kerman
Postal code
Approval date
2013-02-13, 1391/11/25
Ethics committee reference number
K/91/379
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
Cognitive impairment
Timepoint
Befor intervention and 2month later
Method of measurement
BICAMS TEST
Secondary outcomes
empty
Intervention groups
1
Description
cap Bosweilia serrata 300mg BD. 2 months for intervention group
Category
Treatment - Drugs
2
Description
Cap placebo 300mg BD ,2 months for control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
infirmery multiple sclerosis, Shafa hospital
Full name of responsible person
Street address
Shafa hospital
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciensec
Full name of responsible person
Dr. Malekpur
Street address
jomhuri bool, Kerman university of medical sciense
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciensec
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
Shafa hospital, Kerman University of Medical Sciences
Full name of responsible person
Behnaz Sedighi
Position
Associate professor
Other areas of specialty/work
Street address
Shafa hospita
City
Kerman
Postal code
Phone
+98 34 1211 5780
Fax
Email
Behnaz.sedighi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shafa hospital, Kerman University of Medical Sciences
Full name of responsible person
Bhnaz Sedighi
Position
Associate professor
Other areas of specialty/work
Street address
Shafa hospital
City
Kerman
Postal code
Phone
+98 34 1211 5780
Fax
Email
Behnaz.sedighi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shafa hospital, Kerman University of Medical Sciences
Full name of responsible person
Behnaz Sedighi
Position
Associate professor
Other areas of specialty/work
Street address
Shafa hospital
City
Kerman
Postal code
Phone
+98 34 1211 5780
Fax
Email
behnaz.sedighi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)