Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-29 @ 8:21 PM
Study NCT ID:
NCT02976766
Status:
TERMINATED
Last Update Posted:
2025-12-19
First Post:
2016-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gypenosides Treatment for Optic Neuritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Low enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2016-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean retinal nerve fibre layer thickness', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Total macular volume', 'timeFrame': '6 months'}, {'measure': 'Best corrected visual acuity', 'timeFrame': '6 months'}, {'measure': 'Latency and amplitude of visual evoked potentials', 'timeFrame': '6 months'}, {'measure': 'Mean visual field defect', 'timeFrame': '6 months'}, {'measure': 'Number of participants with Adverse events', 'timeFrame': 'Screening until end of study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroprotection', 'Clinical trial', 'Traditional Chinese medicine', 'Axonal loss', 'Jiaogulan', 'Gynostemma pentaphyllum', 'Optical coherence tomography'], 'conditions': ['Optic Neuritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Male and female Chinese patients aged ≥18 to ≤60 years\n2. Patients with a first episode of optic neuritis in the eye of interest\n3. First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product\n4. Best corrected visual acuity in the eye of interest ≤0.8\n\nExclusion criteria\n\n1. Pre-existing multiple sclerosis MS or NMO\n2. Refractive media opacity\n3. Hyperopia \\>5 diopters, myopia \\<-5 diopters, or astigmatism \\>3 diopters\n4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial\n5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)\n6. Existing other retina or optic nerve diseases\n7. Pregnant or females who plan to be pregnant during study'}, 'identificationModule': {'nctId': 'NCT02976766', 'briefTitle': 'Gypenosides Treatment for Optic Neuritis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Guangxi Medical University'}, 'officialTitle': 'Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'GXON-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gypenosides', 'interventionNames': ['Drug: Gypenosides']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gypenosides', 'type': 'DRUG', 'otherNames': ['Jiaogulan Zongdai'], 'description': 'Participants will receive gypenosides 180 mg/day (60 mg three times a day) for 10 days.', 'armGroupLabels': ['Gypenosides']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo three times a day for 10 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'overallOfficials': [{'name': 'Yi Du, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Guangxi Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Yi Du', 'investigatorAffiliation': 'First Affiliated Hospital of Guangxi Medical University'}}}}