This study aims to investigate the effects of evening primrose oil on fatigue and quality of life in patients with multiple sclerosis design study: For example: a randomized, double-blind, controlled placebo study population: people 15 to 55 years old with MS, the main criteria entry to study: a diagnosis based on neurological examination and magnetic resonance imaging confirmed by a doctor neurologist is sent. B :) people 15-55 years c EDSS scores less than 6 (d) of patients in the last month attack (attack) is not new and they did not use the pulse corticosteroids. Main exclusion criteria: (a) the emergence of side effects of discontent from the study (c) of the drug for a week of pregnancy Sample Size: 60 (b) intervention or interventions studied: Medication evening primrose oil group (c) intervention and control intervention time: 3 months (d) the primary outcome: 1) reduce fatigue 2) improving quality of life
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT2015101324520N1
Registration date:2016-01-27, 1394/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-27, 1394/11/07
Registrant information
Name
Hamid Saki
Name of organization / entity
Medical Science Jundishapur
Country
Iran (Islamic Republic of)
Phone
+98 61 3378 5278
Email address
saki.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research،Jundishapur university of medical sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of evening primrose oil on fatigue and quality of life in patients with multiple sclerosis
Public title
The effect of evening primrose oil in the treatment of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) The diagnosis of the neurological examination and magnetic resonance imaging confirmed by a doctor neurologist is sent. 2) persons 15-55 years 3) EDSS score of less than 6, 4) neurological diseases such as stroke or psychiatric, such as depression or not. 5) pregnant women are not tested. 6) autoimmune diseases like lupus or rheumatoid arthritis, and heart as Bdkhymy- not. 7) patients in the last month attack (attack) is not new and they did not use the pulse corticosteroids.";" Exclusion criteria: 1) the emergence of drug complications 2) resentment of the presence in the study 3) of the drug for a week 4) Pregnancy
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
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
Single
Other design features
Using sequences of four permutation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Jundishapur University Of Medical Science
Street address
Jundishapur University Of Medical Sciences Golestan Ahvaz
City
Ahvaz
Postal code
Approval date
2015-09-19, 1394/06/28
Ethics committee reference number
IR.Ajums.REC.1394.348
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
quality of life
Timepoint
Before and 3 months after intervention
Method of measurement
Quality of Life in this study using a questionnaire with 54 questions were Vickrey and colleagues. sclerosis
Secondary outcomes
1
Description
Fatigue
Timepoint
Before and 3 months after intervention
Method of measurement
MFIS was measured using the scale of fatigue in multiple sclerosis
Intervention groups
1
Description
Capsules of evening primrose oil 1 g orally 2 times a day for 3 months in the intervention group
Category
Treatment - Drugs
2
Description
1 gram oral placebo capsules 2 times a day for 3 months in the control group
Manufacturer: Barij Essence
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Teaching Hospitals Of Golestan Ahvaz
Full name of responsible person
N. Majdinasab Associate Professor Of Neurology
Street address
Khuzestan, Ahvaz Golestan Hospital Department Of Neurology
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Jundishapur University Of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Golestan University Of Medical Sciences, Ahvaz City, Khuzestan, Ahvaz, the research center
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 Of Jundishapur University Of Medical Sciences
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
Jundishapur University Of Medical Sciences
Full name of responsible person
Nastaran Majdinasab
Position
Associate Professor Of Neurology
Other areas of specialty/work
Street address
Neurology Department Golestan Hospital Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3012
Fax
Email
N.majdi@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jundishapur University Of Medical Sciences
Full name of responsible person
Nastaran Majdi Nasab
Position
Associate Professor Of Neurology
Other areas of specialty/work
Street address
Neurology Department Golestan Hospital Ahvaz khoozestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3012
Fax
Email
N.majdi@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jundishapur University Of Medical Sciences
Full name of responsible person
Hamid saki
Position
Assistant Of Neurology
Other areas of specialty/work
Street address
Neurology department Golestan hospital Ahvaz khoozestan
City
Ahvaz
Postal code
Phone
+98 61 3374 3012
Fax
Email
saki.h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)