Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-01 @ 8:28 AM
Study NCT ID:
NCT06525792
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2024-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D010126', 'term': 'Ozone'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The expression of SOD(Superoxide dismutase)', 'timeFrame': '7 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Cerebrovascular Disease']}, 'descriptionModule': {'briefSummary': 'Clinical studies applying ozonated autohemotherapy to treat acute cerebrovascular diseases have validated the safety and efficacy of this treatment, as well as explored its mechanism of action.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed by cranial CT or MRI examination, first-ever stroke, hospital admission within \\<24 hours of symptom onset,\n2. age \\>18 years,\n3. NIHSS score between 4 and 15,\n4. TOAST classification as large artery atherosclerosis,\n5. complete clinical records, minimum follow-up period of ≥3 months post-discharge,\n6. willingness to undergo brachial blood puncture treatment, and provision of informed consent\n\nExclusion Criteria:\n\n1. other neurological disorders, cerebral infarction caused by vertebral-basilar artery disease, cardioembolic stroke, or large-vessel vasculitis, acute or chronic infectious diseases, autoimmune or hematologic disorders, malignant tumors, mental abnormalities, severe heart, liver, or kidney dysfunction, intracerebral hemorrhage, and craniocerebral surgery history.\n2. Contraindications for ozone therapy included hyperthyroidism, favism, severe coagulation disorders, and abnormal puncture site barriers'}, 'identificationModule': {'nctId': 'NCT06525792', 'briefTitle': 'A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'LHGJ20190414'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard treatment', 'interventionNames': ['Procedure: Standard therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group 1', 'interventionNames': ['Procedure: Oxygen']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group 2', 'interventionNames': ['Procedure: Ozone']}], 'interventions': [{'name': 'Oxygen', 'type': 'PROCEDURE', 'description': 'Oxygen and standard therapy were given', 'armGroupLabels': ['Experimental group 1']}, {'name': 'Ozone', 'type': 'PROCEDURE', 'description': 'Ozone and standard therapy were given', 'armGroupLabels': ['Experimental group 2']}, {'name': 'Standard therapy', 'type': 'PROCEDURE', 'description': 'Best standard of care', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Fifth Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Heyun Cheng', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}