Comparison of the effect of amantadine and coenzymeQ10 on the fatigue of the Multiple Sclerosis patients Inclusion criteria : Informed consent form and questionnaire filling; FSS greater than or equal to 4.0 Exclusion criteria:Use of sedative-hypnotic drugs in the last 2 months;Pregnancy or lactation; Congestive heart failure;kidney or liver disease; psychiatric disorders; major Depression;asthma;anemia; hyperthyroidism;sleep disorders;diabetes and high blood pressure; alcohol abuse;drug abuse; HMG coa reductase inhibitors; beta blockers; calcium channel blockers; statins, levodopa;Sleep disorders The study population of patients with MS who were referred to a neurology clinic and complain fatigue with FSS equal 4 or more than 4 and they have to fill out a consent form. 15 subjects in each of the two groups taking amantadine,coenzymenQ 10 and placebo (total n = 45) for 28 days at baseline and at the end of this term fss they will be check.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092814792N1
Registration date:2013-11-28, 1392/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-28, 1392/09/07
Registrant information
Name
Arash Bostani
Name of organization / entity
Emam Reza hospital of kermanshah University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6309
Email address
medmehr81@gmail.com
Recruitment status
Recruitment complete
Funding source
Kermanshah Univesity of Medical Science
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of amantadine and coenzymeQ10 on the fatigue of the Multiple Sclerosis patients
Public title
The effect of amantadine and Q10 in fatigue of the Multiple Sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent form and questionnaire filling; FSS greater than or equal to 4.0
Exclusion criteria: Use of sedative-hypnotic drugs in the last 2 months;Pregnancy or lactation; Congestive heart failure;kidney or liver disease; psychiatric disorders; major Depression;asthma;anemia; hyperthyroidism;sleep disorders;diabetes and high blood pressure; alcohol abuse;drug abuse; HMG coa reductase inhibitors; beta blockers; calcium channel blockers; statins, levodopa;Sleep disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Kermanshah University of Medical Science
Street address
Kermanshah University of Medical Science,-Shahid Beheshty boulevard,-kermanshah city,-iran
City
Kermanshah
Postal code
Approval date
2013-04-30, 1392/02/10
Ethics committee reference number
9612
Health conditions studied
1
Description of health condition studied
Fatigue in multiple sclerosis patients
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Fatige
Timepoint
The beginning and 4 weeks after the end of study
Method of measurement
FSS Questionnaire
Secondary outcomes
1
Description
Drug side effects
Timepoint
Bigenning,during the study,and four weeks after the end of study