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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Spinocerebellar Ataxia

Keywords

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Neuroinflammatory Diseases Nervous System Diseases Spinocerebellar Ataxia Antrodia Cinnamomea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Placebo-controlled crossover design.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

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

Group Type ACTIVE_COMPARATOR

Antrodia cinnamomea Products

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Antrodia cinnamomea Products

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALPS Biotech CO. LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu Hsuan Chang

Role: CONTACT

Phone: +886955551989

Email: [email protected]

Irene Tsai

Role: CONTACT

Phone: +886925772995

Email: [email protected]

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