Clinical trial comparing the effects of fish liver oil and boswellia serrata with placebo on fatigue of multiple sclerosis patient. In this study we used fish liver oil- with its large amounts of omega 3- and Boswellia Serrata concrete in MS patients and evaluated its effects on these patients' fatigue scale. Material: In this study, we selected 65 multiple sclerosis patients among those who referred to the multiple sclerosis consultation center. All of them were under treatment with interferon and no-one had major depression (according to depression beck scale). They were separated into three groups, one receiving placebo (21 patients: capsules filled with starch) in addition to interferon. Second group got liver fish oil in addition to interferon. Third group got boswellic acid. These drugs were packaged and encoded with pharmacognosis department of Ahvaz Jundishapour University of Medical Science and were given to patients with multiple sclerosis society of Khoozestan. So, it is double blinded study because patients and researchers did not know about type of drug used. After one month of follow up, fatigue scales were collected and then compared to the pre-test scales of fatigue, applying a paired t- test
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020812399N1
Registration date:2013-09-30, 1392/07/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-30, 1392/07/08
Registrant information
Name
Salman Fatemi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1335 1298
Email address
fatemi.salman@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Science
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effects of fish liver oil and Boswellia Serrata with placebo on fatigue of multiple sclerosis patients
Public title
Comparing the effects of fish liver oil and Boswellia Serrata with placebo on multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1- Age between 20 and 55
2- Multiple sclerosis patients taking Interferon
4- No new emotional stress when the patients are under the study
5- No cytotoxic therapy
Exclusion criteria :
1-Younger than 20 and older than 55
2-Intake of corticosteroid pulse during study
3- New emotional stress on the patient during study
4- New multiple sclerosis attack during study
5- Cytotoxic drug during study
6- Glatiramer acetat ingestion during study
Age
From 3 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
65
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 committee of Ahvaz Jundishapour University of Medical Science
Street address
Golestan St.
City
Ahvaz
Postal code
81336-55676
Approval date
2010-11-21, 1389/08/30
Ethics committee reference number
Eth091
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
fatigue scale
Timepoint
before intervention and one month after beginning of intervention
Method of measurement
fatigue scale of the patient of multiple sclerosis as a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: who took placebo (placebo was capsules like Boswellia capsules filled with starch)
Category
Treatment - Drugs
2
Description
Intervention group 1: fish liver oil (1500mg per day) produced by USA
Category
Treatment - Drugs
3
Description
Intervention group 2: boswellia (900mg per day). These capsules were synthesized in Ahvaz Pharmacology University. Method of synthesis was concentration of Boswellia Hydroalcoholic solution
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple sclerosis Society of Khoozestan
Full name of responsible person
Nastaran Madjdinasab, Salman Fatemi
Street address
Rehabilitation college of Ahvaz Jundishapor University of Medical Science of
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jondishapour University of Medical Science
Full name of responsible person
Dr Feghhi
Street address
Ahvaz ,Golestan St.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jondishapour University of Medical Science
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
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Salman Fatemi
Position
Resident of Neurology
Other areas of specialty/work
Street address
Building Eram 2, between Azar and Dey St., Khordad St.
City
Ahvaz
Postal code
81336-13655
Phone
+98 61 1335 1298
Fax
Email
fatemi.salman@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Salman Fatemi
Position
Resident of Neurology
Other areas of specialty/work
Street address
Building Eram 2, Between Azar and Dey, Khordad St.
City
Ahvaz
Postal code
81336-13655
Phone
+98 61 1335 1298
Fax
Email
fatemi.salman@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Science
Full name of responsible person
Salman Fatemi
Position
Resident of Neurology
Other areas of specialty/work
Street address
Building Eram 2, between Azad and Dey, Khordad St.
City
Ahvaz
Postal code
81336-55676
Phone
+98 61 1335 1298
Fax
Email
fatemi.salman@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)