A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
1 other identifier
interventional
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedFirst Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedJuly 29, 2024
July 1, 2024
2.2 years
July 25, 2024
July 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The expression of SOD(Superoxide dismutase)
7 days
Study Arms (3)
Control group
ACTIVE COMPARATORStandard treatment
Experimental group 1
EXPERIMENTALExperimental group 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Confirmed by cranial CT or MRI examination, first-ever stroke, hospital admission within \<24 hours of symptom onset,
- age \>18 years,
- NIHSS score between 4 and 15,
- TOAST classification as large artery atherosclerosis,
- complete clinical records, minimum follow-up period of ≥3 months post-discharge,
- willingness to undergo brachial blood puncture treatment, and provision of informed consent
You may not qualify if:
- 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.
- Contraindications for ozone therapy included hyperthyroidism, favism, severe coagulation disorders, and abnormal puncture site barriers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Director
Study Record Dates
First Submitted
July 25, 2024
First Posted
July 29, 2024
Study Start
August 1, 2020
Primary Completion
October 31, 2022
Study Completion
October 31, 2022
Last Updated
July 29, 2024
Record last verified: 2024-07