The purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.
Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
3mg oral, daily, one hour before sleep
Iranian Center for Neurological Researches, Imam Khomeini Hospital
Tehran, Tehran Province, Iran
Number of relapses
Time frame: one year
EDSS
Expanded Disability Status Scale reported by a neurologist
Time frame: one year (every 3 months)
PASAT-3 score
Paced Auditory Serial Addition Test 3seconds score
Time frame: one year (at the beginning and end of the year)
proportion of brain gray matter volume to intracranial volume
Time frame: one year (at the beginning and end of the year)
MSFC score
Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)
Time frame: one year (at the beginning and end of the year)
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