Recruiting NCT06633003
Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antrodia cinnamomea Products, Antrodia cinnamomea Products.
- Who it may be relevant to
- Registry conditions: Spinocerebellar Ataxia. Basic parameters: 30 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.
Detailed description
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.
Interventions
- Dietary supplement Antrodia cinnamomea Products
Placebo-controlled crossover design: * Dietary Supplement: Antrodia Cinnamomea Products * Dietary Supplement: Placebo - Dietary supplement Antrodia cinnamomea Products
A arm : Stage I : • Dietary Supplement: Antrodia Cinnamomea Products Stage II: • Dietary Supplement: Placebo B arm : Stage I : • Dietary Supplement: Placebo Stage II: • Dietary Supplement: Antrodia Cinnamomea Products
Primary outcome measures
- 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. [Time frame: Up to 48 weeks of treatment.]
Secondary outcome measures (6)
- Resting-state electroencephalogram (EEG) will be collected [Time frame: Up to 48 weeks of treatment.]
- Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma. [Time frame: Up to 48 weeks of treatment.]
- The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. [Time frame: 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. [Time frame: Up to 48 weeks of treatment.]
- Hospital Anxiety and Depression Scale (HADS) [Time frame: Up to 48 weeks of treatment.]
- The 8 Metre Walk Test. [Time frame: Up to 48 weeks of treatment.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
Taiwan · 1 center
- National Taiwan University Cancer Center — Taipei
Identifiers
NCT: NCT06633003 · 202404011RSA