Usefulness of Alpha-lipoic Acid Combined With B Vitamins for the Treatment of Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)
研究概览
简要总结
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
详细描述
Restless legs syndrome, also known as Willis-Ekbom disease, is a neurological disorder characterised by uncomfortable sensations in the legs and an urge to move them. In Spain, its prevalence range is estimated to be between 11.6% - 19.5% in adults, but it is difficult to know due to underdiagnosis. Alpha-lipoic acid (ALA) and B vitamins have emerged as potential treatments due to their roles in reducing oxidative stress and associated vitamin deficiencies. The Tiobec® 400 (T400) supplement combines ALA, B vitamins, E, and C, and its efficacy and safety in alleviating RLS symptoms, along with its impact on anthropometric measures, are under investigation. This study aims to explore therapeutic options for managing RLS, with promising results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be a minimum of 18 years of age.
- •They must have a primary diagnosis of RLS without prior therapeutic interventions for the ailment.
- •They need to provide explicit consent via an informed consent document.
排除标准
- •Patients diagnosed with pathologies other than RLS that affect sleep quality.
- •Those with persistent renal diseases or any other chronic, severe medical condition.
结局指标
主要结局
Measure the subjective RLS symptoms of the participants through the IRLSSG rating scale (IRLS)
时间窗: 6 months
This scale contains 10 items, rated from 0 to 4, according to the severity reported by the patient (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.). The cumulative scores are categorized as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40).
次要结局
- Anthropometric parameters of the patients.(6 Months)
- Patients' body measurements(6 Months)
- Measurements of patient anatomy.(6 Months)
- Measurements of patient anatomy(6 Months)
- Patients' body characteristics.(6 Months)