Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

NCT ID: NCT05508113

Last Updated: 2022-08-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to observe the efficacy and safety of ozonated autohemotherapy in patients of post-ischemic stroke insomnia and to explore its mechanism of action.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-ischemic Stroke Insomnia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

No intervention was given to this group of patients

Group Type NO_INTERVENTION

No interventions assigned to this group

20-40ug/ml ozone

ozone autohemotherapy

Group Type EXPERIMENTAL

ozone autohemotherapy

Intervention Type OTHER

After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ozone autohemotherapy

After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* meet the diagnostic criteria for ischemic stroke; Insomnia quality index (ISI) score \> 7 points

Exclusion Criteria

* acute ischemic stroke; associated with failure of important organs or malignant tumor; patients with worsening condition, new cerebral infarction or secondary cerebral hemorrhage; with comprehension or cognitive impairment, unable to fully understand the scale and unable to cooperate with treatment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mengmeng Chen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mengmeng Chen

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lijing Zhao, Doctor

Role: CONTACT

13756281155

References

Explore related publications, articles, or registry entries linked to this study.

Sekerdag E, Solaroglu I, Gursoy-Ozdemir Y. Cell Death Mechanisms in Stroke and Novel Molecular and Cellular Treatment Options. Curr Neuropharmacol. 2018;16(9):1396-1415. doi: 10.2174/1570159X16666180302115544.

Reference Type BACKGROUND
PMID: 29512465 (View on PubMed)

Masan J, Sramka M, Rabarova D. The possibilities of using the effects of ozone therapy in neurology. Neuro Endocrinol Lett. 2021 Mar;42(1):13-21.

Reference Type BACKGROUND
PMID: 33932964 (View on PubMed)

Kadir K, Syam Y, Yusuf S, Zainuddin M. Ozone Therapy on Reduction of Bacterial Colonies and Acceleration of Diabetic Foot Ulcer Healing. Home Healthc Now. 2020 Jul/Aug;38(4):215-220. doi: 10.1097/NHH.0000000000000889.

Reference Type BACKGROUND
PMID: 32618780 (View on PubMed)

Martinez-Sanchez G, Delgado-Roche L, Diaz-Batista A, Perez-Davison G, Re L. Effects of ozone therapy on haemostatic and oxidative stress index in coronary artery disease. Eur J Pharmacol. 2012 Sep 15;691(1-3):156-62. doi: 10.1016/j.ejphar.2012.07.010. Epub 2012 Jul 13.

Reference Type BACKGROUND
PMID: 22796450 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Autologous Stem Cell Therapy in Stroke
NCT02245698 WITHDRAWN PHASE1
Melatonin for Prevention of Post Stroke Delirium
NCT04122599 UNKNOWN PHASE2/PHASE3