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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I: Antrodia Cinnamomea Products + Stage II: Placebo | Active Comparator | 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 |
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| Stage I: Placebo + Stage II: Antrodia Cinnamomea Products | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antrodia cinnamomea Products | Dietary Supplement | Placebo-controlled crossover design:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 48 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state electroencephalogram (EEG) will be collected | Successful attainment of Resting-state electroencephalogram (EEG). To compare the EEG recordings in different frequency band change before, during, and after the Antrodia Cinnamomea Products used. | Up to 48 weeks of treatment. |
| Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin. | Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin. | Up to 48 weeks of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Hsuan Chang | Contact | +886955551989 | hsuan1989@alps.com.tw | |
| Irene Tsai | Contact | +886925772995 | ibox526@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MingChe Kuo | National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Cancer Center | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D020754 | Spinocerebellar Ataxias |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Placebo-controlled crossover design.
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| Antrodia cinnamomea Products | 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 |
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Monitor 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. | The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses. The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch once the last peg is in the container. Scoring: The number of seconds it takes for the patient to complete the test, where an increase in the total score indicates a worsening of symptoms. | 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. | PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. It included seven components with a global PSQI score > 5 is indicative of poor sleep quality. | Up to 48 weeks of treatment. |
| Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. | Up to 48 weeks of treatment. |
| The 8 Metre Walk Test. | The 8 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function Scoring The total time taken to ambulate 8 meters is recorded. Timing starts when the toes pass the 0-meter mark. Timing stops when the toes pass the 8-meter mark. The 8-meter is then divided by the total time taken (in seconds) to completed. Increase in the total time indicates a worsening of symptoms. | Up to 48 weeks of treatment. |
| D013132 |
| Spinocerebellar Degenerations |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |