An interventional study of Rectal ozone sessions and Conventional rehabilitation program in Rectal Ozone, Neuroprotector and CNS, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Acquired brain injury (ABI) from primary neurologic diagnoses accounts for 20% of all pediatric critical care admissions and more than 60,000 hospital admissions annually.
Ozone (O3) gas was discovered in the 1840s, and soon after that, the scientific community began to expand past the notion that it was just another gas of the Earth's atmosphere.
Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
Other: Rectal ozone sessions
Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
Other: Conventional rehabilitation program
Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
Assessment of muscle Tone
Assessment of muscle tone (degree of spasticity) of affected child according to Modified Ashworth's Scale. Ashworth's scale is a 6-point scale, from 0 to 4, with higher scores indicating greater spasticity.
Time frame: 6 months post-sessions
Incidence of reduction in neuroinflammation
Incidence of reduction in neuroinflammation will be recorded.
Time frame: 6 months post-sessions
Assessment of quality of life
Assessment of quality of life including emotional well-being or social interaction will be recorded.
Time frame: 6 months post-sessions
Incidence of adverse effects
Incidence of adverse effects will be recorded.
Time frame: 6 months post-sessions
Measurement of age-related response variability
Age-related response variability by evaluating how different age groups respond to treatment will be recorded.
Time frame: 6 months post-sessions
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
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Al-Azhar University