Fatigue Clinical Trial
Official title:
Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis
Verified date | October 2012 |
Source | Isfahan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Al-zahra university hospital | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | 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. | at one month after treatment | Yes |
Secondary | Quality Of Life | Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100. | at one month after treatment | Yes |
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