Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-02 @ 4:24 AM
Study NCT ID:
NCT06633003
Status:
RECRUITING
Last Update Posted:
2024-12-10
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020754', 'term': 'Spinocerebellar Ataxias'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D002524', 'term': 'Cerebellar Ataxia'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Placebo-controlled crossover design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': 'Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.'}], 'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Resting-state electroencephalogram (EEG) will be collected', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': '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.'}, {'measure': 'Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': 'Monitor Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.'}, {'measure': 'The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': 'The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.\n\nThe 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.\n\nScoring:\n\nThe number of seconds it takes for the patient to complete the test, where an increase in the total score indicates a worsening of symptoms.'}, {'measure': 'Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study.', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': '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.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': '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.'}, {'measure': 'The 8 Metre Walk Test.', 'timeFrame': 'Up to 48 weeks of treatment.', 'description': '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\n\nScoring 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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroinflammatory Diseases', 'Nervous System Diseases', 'Spinocerebellar Ataxia', 'Antrodia Cinnamomea'], 'conditions': ['Spinocerebellar Ataxia']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 30 to 70 years, whose native language is Chinese.\n2. Patients diagnosed with Spinocerebellar Ataxia.\n3. Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).\n4. Individuals who can read and write in Chinese and communicate in Chinese.\n5. Agree to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.\n2. Pregnant women and breastfeeding mothers.\n3. Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.\n4. Patients with other factors that prevent them from continuing to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06633003', 'briefTitle': 'Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALPS Biotech CO. LTD'}, 'officialTitle': 'Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients', 'orgStudyIdInfo': {'id': '202404011RSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stage I: Antrodia Cinnamomea Products + Stage II: Placebo', 'description': 'Crossover design:\n\nDuring 0 week\\~8 weeks is Stage I :\n\n• Dietary Supplement: Antrodia Cinnamomea Products\n\nDuring 16 weeks\\~ 24 weeks is Stage II:\n\n• Dietary Supplement: Placebo', 'interventionNames': ['Dietary Supplement: Antrodia cinnamomea Products']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage I: Placebo + Stage II: Antrodia Cinnamomea Products', 'description': 'Crossover design:\n\nDuring 0 week\\~8 weeks is Stage I :\n\n• Dietary Supplement: Placebo\n\nDuring 16 weeks\\~ 24 weeks is Stage II:\n\n• Dietary Supplement: Antrodia Cinnamomea Products', 'interventionNames': ['Dietary Supplement: Antrodia cinnamomea Products']}], 'interventions': [{'name': 'Antrodia cinnamomea Products', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo-controlled crossover design:\n\n* Dietary Supplement: Antrodia Cinnamomea Products\n* Dietary Supplement: Placebo', 'armGroupLabels': ['Stage I: Antrodia Cinnamomea Products + Stage II: Placebo']}, {'name': 'Antrodia cinnamomea Products', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A arm :\n\nStage I :\n\n• Dietary Supplement: Antrodia Cinnamomea Products\n\nStage II:\n\n• Dietary Supplement: Placebo\n\nB arm :\n\nStage I :\n\n• Dietary Supplement: Placebo\n\nStage II:\n\n• Dietary Supplement: Antrodia Cinnamomea Products', 'armGroupLabels': ['Stage I: Placebo + Stage II: Antrodia Cinnamomea Products']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Irene Tsai', 'role': 'CONTACT', 'email': 'ibox526@gmail.com', 'phone': '+886925772995'}, {'name': 'MingChe Kuo', 'role': 'CONTACT'}], 'facility': 'National Taiwan University Cancer Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yu Hsuan Chang', 'role': 'CONTACT', 'email': 'hsuan1989@alps.com.tw', 'phone': '+886955551989'}, {'name': 'Irene Tsai', 'role': 'CONTACT', 'email': 'ibox526@gmail.com', 'phone': '+886925772995'}], 'overallOfficials': [{'name': 'MingChe Kuo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALPS Biotech CO. LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}