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

NCT ID: NCT06525792

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-10-31

Brief Summary

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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

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Conditions

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Acute Ischemic Cerebrovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

Standard treatment

Group Type ACTIVE_COMPARATOR

Standard therapy

Intervention Type PROCEDURE

Best standard of care

Experimental group 1

Group Type EXPERIMENTAL

Oxygen

Intervention Type PROCEDURE

Oxygen and standard therapy were given

Experimental group 2

Group Type EXPERIMENTAL

Ozone

Intervention Type PROCEDURE

Ozone and standard therapy were given

Interventions

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Oxygen

Oxygen and standard therapy were given

Intervention Type PROCEDURE

Ozone

Ozone and standard therapy were given

Intervention Type PROCEDURE

Standard therapy

Best standard of care

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Heyun Cheng

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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LHGJ20190414

Identifier Type: -

Identifier Source: org_study_id

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