Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients

ALPS Biotech CO. LTD

Status: Enrolling

Conditions: Spinocerebellar Ataxia

Treatments: Dietary Supplement: Antrodia cinnamomea Products

Study type: Interventional

Funder types: Industry

Identifiers

NCT06633003

202404011RSA

Details and patient eligibility

About

This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 30 to 70 years, whose native language is Chinese.
2. Patients diagnosed with Spinocerebellar Ataxia.
3. Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).
4. Individuals who can read and write in Chinese and communicate in Chinese.
5. Agree to participate in the study.

Exclusion criteria

1. Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.
2. Pregnant women and breastfeeding mothers.
3. Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.
4. Patients with other factors that prevent them from continuing to participate in this study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Stage I: Antrodia Cinnamomea Products + Stage II: Placebo

Active Comparator group

Description:

Crossover design: During 0 week\~8 weeks is Stage I : • Dietary Supplement: Antrodia Cinnamomea Products During 16 weeks\~ 24 weeks is Stage II: • Dietary Supplement: Placebo

Treatment:

Dietary Supplement: Antrodia cinnamomea Products

Dietary Supplement: Antrodia cinnamomea Products

Stage I: Placebo + Stage II: Antrodia Cinnamomea Products

Placebo Comparator group

Description:

Crossover design: During 0 week\~8 weeks is Stage I : • Dietary Supplement: Placebo During 16 weeks\~ 24 weeks is Stage II: • Dietary Supplement: Antrodia Cinnamomea Products

Treatment:

Dietary Supplement: Antrodia cinnamomea Products

Dietary Supplement: Antrodia cinnamomea Products