Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fatigue
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of fatigue and Quality of Life of MS patients.
详细描述
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
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria with a baseline of Expanded Disability Status Score (EDSS)of less than 5.0
排除标准
- •prior use of ginseng or any other tonic agents, glucocorticoids, warfarin, digoxin, aspirin, furosemide, caffeine, ephedra and anti-platelet agents within one month prior to enrollment;
- •Pregnancy or lactation;
- •history of renal failure; and,
- •lack of appropriate adherence to the study protocol.
研究组 & 干预措施
Ginseng
Ginseng, tablet, 250 mg, twice, 3 months
干预措施: Ginseng (Drug)
Placebo
Placebo, tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue
时间窗: at 3 months after treatment
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.
次要结局
- Quality Of Life(at 3 months after treatment)
研究者
Hamidreza Shemshaki
research assistant
Isfahan University of Medical Sciences