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

Not Applicable

Completed

• Conditions: Acute Ischemic Cerebrovascular Disease
• Interventions: Procedure: Oxygen; Procedure: Ozone; Procedure: Standard therapy

• Registration Number: NCT06525792
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group 1	Oxygen	-
Experimental group 2	Ozone	-
Control group	Standard therapy	Standard treatment

Primary Outcome Measures

Name	Time	Method
The expression of SOD(Superoxide dismutase)	7 days

Trial Locations

Locations (1)

Fifth Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China