Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in the total score of the Scale for the Assessment and Rating of Ataxia (SARA) at 48 weeks in subjects is compared to natural history.
研究概览
简要总结
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.
详细描述
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients: a randomized, double-blind, placebo-controlled crossover design, and parallel clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30 to 70 years, whose native language is Chinese.
- •Patients diagnosed with Spinocerebellar Ataxia.
- •Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).
- •Individuals who can read and write in Chinese and communicate in Chinese.
- •Agree to participate in the study.
排除标准
- •Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.
- •Pregnant women and breastfeeding mothers.
- •Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.
- •Patients with other factors that prevent them from continuing to participate in this study.
结局指标
主要结局
Change from Baseline in the total score of the Scale for the Assessment and Rating of Ataxia (SARA) at 48 weeks in subjects is compared to natural history.
时间窗: Up to 48 weeks of treatment.
To compare the effectiveness of Antrodia Cinnamomea Products in treating SCA, as measure by the Scale for the Assessment and Rating of Ataxia (SARA), in subjects randomized to treatment after 24 weeks of treatment. The SARA is a scale with a range of 0 to 40, where an increase in the total score indicates a worsening of symptoms.
次要结局
- Resting-state electroencephalogram (EEG) will be collected(Up to 48 weeks of treatment.)
- Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.(Up to 48 weeks of treatment.)
- The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.(Up to 48 weeks of treatment.)
- Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study.(Up to 48 weeks of treatment.)
- Hospital Anxiety and Depression Scale (HADS)(Up to 48 weeks of treatment.)
- The 8 Metre Walk Test.(Up to 48 weeks of treatment.)