IRCT201210051859N6已完成1 期
Clinical trial of the effect of Thyroid hormones in comparison to placebo on Magnetization Transfer Ratio in Gadolinium enhancing lesions in magnetic resonance imaging of patients with Multiple Sclerosis
Tehran University Of Medical Sciences,vice chancellor for research0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 23 years 至 54 years（—）
- 性别
- All
入选标准
- •1)Definite diagnosis of relapsing-remitting Multiple Sclerosis according to McDonald criteria revised in 2010 (Polman, Reingold et al. 2011).
- •2)Admission during the relapse phase (in the first 2 weeks from the onset of symptoms)
- •Relapse definition: appearance of a new sign or exacerbation of a present sign which lasts for at least 24 hours without infection or any other possible reason. (Signs consist of Hemiparesis, paraparesis, hemiataxia, myelopathy, any sensation disorder.)
- •3)5 days IV Methylprednisolone therapy for relapse.
- •4)Expanded Disability Scale Status (before relapse) equal or less than 5.5.
- •5)Age between 23 and 55 years old.
- •6)Minimum disease duration of 5 years.
- •Exclusion criteria:
- •1)Thyroid function tests impairment (Thyroid Stimulating Hormone level less than 1 µIU/mL).
- •2)Administration of other drugs containing thyroid hormones during /prior to the study.
- •3)Prior administration of cytotoxic/immunosuppressive medications (e.g. mitoxantrone, azathioprine, cellcept)
- •4)Existence of any medical condition which is a contraindication for administering thyroid hormones: history of arrhythmia, myocardial infarction or congestive heart disease, heart failure, resting pulse rate more than 90/min, history of autoimmune thyroid disease, thyroid adenoma, hyperthyroidism, adrenal cortical insufficiency, diabetes, pregnancy, breast feeding, and women in reproductive age who do not use a safe birth control method.
- •5)History of central nervous system disorders other than multiple sclerosis, psychiatric, metabolic, rheumatologic and autoimmune disorders, and drug or alcohol abuse during the last month before study.
- •6)History of brain damage, cancer, chronic liver, kidney, heart or endocrine disease and vitamin D metabolic disorders.
- •7)Medications interfering absorption or metabolism of thyroid hormones such as oral contraceptives and Cholestyramine.
- •8)Medications which absorption or metabolism is affected by thyroid hormones, such as Tricyclic antidepressants and anticoagulants.
- •9)Abnormal rhythm or repolarization phase disorders in Electrocardiogram.
- •10)Disability to take Magnetic resonance imaging.
- •11)Disability to read or understand the informed consent.
- •12)Participation in any other clinical trial during the past 3 months.
排除标准
- 未提供
研究者
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