Acute Ischemic Cerebrovascular DiseaseNCT06525792
A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
A study testing Oxygen, Ozone and Standard therapy in people with Acute Ischemic Cerebrovascular Disease, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Cerebrovascular Disease
- What is being tested?
- Oxygen, Ozone and Standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
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.
- Conditions
- Acute Ischemic Cerebrovascular Disease
- Being tested
- Oxygen, Ozone, Standard therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenProcedure or surgery
Oxygen and standard therapy were given
OzoneProcedure or surgery
Ozone and standard therapy were given
Standard therapyProcedure or surgery
Best standard of care
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard treatment Receives: Procedure: Standard therapy |
| Experimental group 1 | Experimental | Not described Receives: Procedure: Oxygen |
| Experimental group 2 | Experimental | Not described Receives: Procedure: Ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression of SOD(Superoxide dismutase)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heyun Cheng, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525792
- Sponsor's protocol ID
- LHGJ20190414
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Ozone Autohemotherapy for the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06525792
- Acronym / sponsor ID
- LHGJ20190414
- Conditions
- Acute Ischemic Cerebrovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Standard therapyStandard treatment |
| Experimental group 1 | Experimental | Procedure: Oxygen |
| Experimental group 2 | Experimental | Procedure: Ozone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenOxygen and standard therapy were given | Procedure or surgery | Experimental group 1 |
| OzoneOzone and standard therapy were given | Procedure or surgery | Experimental group 2 |
| Standard therapyBest standard of care | Procedure or surgery | Control group |
Primary outcome
The expression of SOD(Superoxide dismutase)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen, Ozone and Standard therapy in people with Acute Ischemic Cerebrovascular Disease, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression of SOD(Superoxide dismutase) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.