Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
NCT ID: NCT06633003
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-09-16
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Stage I: Antrodia Cinnamomea Products + Stage II: Placebo
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
Antrodia cinnamomea Products
Placebo-controlled crossover design:
* Dietary Supplement: Antrodia Cinnamomea Products
* Dietary Supplement: Placebo
Stage I: Placebo + Stage II: Antrodia Cinnamomea Products
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
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
Interventions
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Antrodia cinnamomea Products
Placebo-controlled crossover design:
* Dietary Supplement: Antrodia Cinnamomea Products
* Dietary Supplement: Placebo
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
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
70 Years
ALL
No
Sponsors
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ALPS Biotech CO. LTD
INDUSTRY
Responsible Party
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Principal Investigators
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MingChe Kuo
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan University Cancer Center
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Irene Tsai
Role: primary
MingChe Kuo
Role: backup
Other Identifiers
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202404011RSA
Identifier Type: -
Identifier Source: org_study_id