A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke

Zhengzhou University

Status: Completed

Conditions: Acute Ischemic Cerebrovascular Disease

Treatments: Procedure: Standard therapy; Procedure: Ozone; Procedure: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06525792

LHGJ20190414

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed by cranial CT or MRI examination, first-ever stroke, hospital admission within <24 hours of symptom onset,
2. age >18 years,
3. NIHSS score between 4 and 15,
4. TOAST classification as large artery atherosclerosis,
5. complete clinical records, minimum follow-up period of ≥3 months post-discharge,
6. willingness to undergo brachial blood puncture treatment, and provision of informed consent

Exclusion criteria

1. 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.
2. Contraindications for ozone therapy included hyperthyroidism, favism, severe coagulation disorders, and abnormal puncture site barriers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 3 patient groups

Control group

Active Comparator group

Description:

Standard treatment

Treatment:

Procedure: Standard therapy

Experimental group 1

Experimental group

Treatment:

Procedure: Oxygen

Experimental group 2

Experimental group

Treatment:

Procedure: Ozone