Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- proportion of brain gray matter volume to intracranial volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite diagnosis of relapsing-remitting multiple sclerosis
- •EDSS <=5
- •at least 6months consumption of interferon beta 1a
排除标准
- •illiteracy
- •evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes
- •relapse in the last 3 months
- •pregnancy or deciding to become pregnant during the following year
- •regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin
- •history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases
研究组 & 干预措施
Melatonin
干预措施: Melatonin (Drug)
Placebo
干预措施: Melatonin (Drug)
结局指标
主要结局
proportion of brain gray matter volume to intracranial volume
时间窗: one year (at the beginning and end of the year)
EDSS
时间窗: one year (every 3 months)
Expanded Disability Status Scale reported by a neurologist
Number of relapses
时间窗: one year
PASAT-3 score
时间窗: one year (at the beginning and end of the year)
Paced Auditory Serial Addition Test 3seconds score
次要结局
- MSFC score(one year (at the beginning and end of the year))