ISRCTN87818535已完成未知
A novel medical nutrition formula indicates a possible new approach for relapsing multiple sclerosis treatment: a double-blind, randomized, placebo-controlled clinical trial of efficacy and safety
Ministry of Commerce Industry and Tourism (Cyprus)0 个研究点目标入组 80 人开始时间: 2011年5月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2013 results in https://pubmed.ncbi.nlm.nih.gov/23599375/ (added 18/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men and women
- •2. Ages of between 18 and 65 years
- •3. Diagnosis of relapsing remitting Multiple Sclerosis (RRMS)
- •4. A score of 0.0 to 5.5 on the Expanded Disability Status Scale (EDSS)
- •5. Undergone MRI showing lesions consistent with MS
- •6. At least one medically documented relapse within the 24 months before beginning of the study and who had been receiving approximately the same disease modified treatment (DMT) during the two years before enrolment
排除标准
- •1. Prior immunosuppressants or monoclonal antibodies therapy
- •2. Pregnancy or nursing
- •3. Any severe disease other than MS compromising organ function
- •4. Patients with primary progressive or secondary progressive disease
- •5. Patients known to have a history of recent drug or alcohol abuse
- •6. Unable to follow the protocol from the intent to treat analysis (ITT)
- •7. Any patients that changed type of the disease (i.e RRMS to secondary progressive)
- •8. Consumption of any additional food supplement formula, vitamin of any type or any form of polyunsaturated fatty acid (PUFA) at any time during the trial
研究者
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