Fatigue
Conditions
Keywords
Multiple sclerosis, Melatonin, Fatigue, Quality of life
Brief summary
The purpose of this study was to evaluate the efficacy and safety of Melatonin in treatment of fatigue and Quality of Life of MS patients.
Detailed description
Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS
Interventions
DRUGMelatonin
it is kind of drug
DRUGPlacebo
It is Placebo
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria 2. a baseline of Expanded Disability Status Score (EDSS)of less than 5.0 3. aged between 18 and 55 years of either sex 4. treated with one type of interferon beta-1a (IFNB-1a); 5. signed an informed consent
Exclusion criteria
1. clinical relapsing of MS during past 30 days; 2. use of melatonin and warfarin within 30 days prior to participation; 3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, NSAIDS, aspirin ; 4. working more than one nighttime shift per month; 5. Pregnancy or lactation; 6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ; 7. failure to adhere to the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | at one month after treatment | Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality Of Life | at one month after treatment | Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100. |
Countries
Iran
Outcome results
None listed