Boswellia Serrata (BS) had anti-inflammatory effects and neuroprotective activity. The aim of this study is to determine whether BS improves cognitive performance among patients with multiple sclerosis (MS) and cognitive impairment (CI). This double-blind, randomized, placebo-controlled trial compared BS 600 mg twice a day with placebo. 60 relapsing-remitting MS (RRMS) patients were selected (30 persons in each group), who had subjective cognitive complaints and the minimal assessment of cognitive function in MS (MACFIMS) was carried out, then after 2 months treatment duration, MACFIMS repeated again and the secondary results were recorded and analyzed.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015042021862N1
Registration date:2015-05-19, 1394/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-19, 1394/02/29
Registrant information
Name
Seiedeh Khatoun Mousavinejad
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3375 4516
Email address
mousavinejad.skh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Boswellia Serrata on Cognitive impairment in Multiple Sclerosis
Public title
Effect of Boswellia Serrata on Cognitive impairment in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with Relapsing-Remitting MS (RRMS); Patients with cognitive impairment; Relapse free in the last 6 weeks before starting of assessments
Exclusion criteria: Current major depression; Preexisting medical or psychiatric disorders associated with cognitive dysfunction; Developmental disease; Drug or alcohol abuse, Patients with Expanded Disability Status Scale (EDSS)>3; New MS attacks and received corticosteroids up to 6 weeks before the study and pregnant or breastfeeding
Age
From 15 years old to 56 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Commitee, Ahvaz Jundishapur University of Medical Sciences,
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
Ahaz
Postal code
6135715794
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
Ajums.REC.1393.261
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 impairement
Timepoint
Before treatment, 2 months after treatment
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Boswellia Serrata, 600 mg, twice a day, for 2 months