Effect of Melatonin on Multiple Sclerosis Related Fatigue
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Study of Melatonin in Treatment of Fatigue in Multiple Sclerosis|
- Fatigue [ Time Frame: at one month after treatment ] [ Designated as safety issue: Yes ]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.
- Quality Of Life [ Time Frame: at one month after treatment ] [ Designated as safety issue: Yes ]Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100.
|Study Start Date:||May 2012|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Melatonin
Melatonin, Tablet, 3 mg, once, one month
it is kind of drug
Placebo Comparator: Placebo
It is Placebo
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718678
|Iran, Islamic Republic of|
|Al-zahra university hospital|
|Isfahan, Iran, Islamic Republic of, 7007|