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The efficacy of edaravone-dexborneol in treating idiopathic normal pressure hydrocephalus and the mechanism study based on metabolomics

The efficacy of edaravone-dexborneol in treating idiopathic normal pressure hydrocephalus and the mechanism study based on metabolomics

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125153
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-01-13
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic normal pressure hydrocephalus

Interventions

Non-surgical + Medication Group:None
Non-surgical group + Non-medication group:None
Surgery + Medication Group:None
Surgery + Non-drug Treatment Group:None

Sponsors

Tianjin Huanhu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 60 years old, with a hidden onset, slow progression, but sometimes the symptoms may fluctuate, including temporary improvement or deterioration of the symptoms; 2. At least one of the following symptoms - gait disorder, cognitive impairment, or bladder dysfunction - must be present, and these symptoms cannot be fully explained by other diseases. 3. Evidence of enlarged ventricles detected by cranial CT or MRI: Evans index (EI) = 0.3 or when EI 0.42, brain/ventricle ratio (BVR) < 1.0 (through the AC plane) and/or BVR < 1.5 (through the PC plane). 4. Tap Test(+); 5. Voluntarily participate in this experimental study; 6. The participants were fully informed about the content of this study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Age > 80 years old; 2. Due to the patient's inability to cooperate or for other reasons, they were unable to return to the research center for follow-up assessment and design of the diversion procedure; 3. Other disorders that cause enlargement of the ventricles, such as subarachnoid hemorrhage, meningitis, brain trauma, congenital or developmental hydrocephalus, etc. 4. Patients with severe liver and kidney dysfunction, as well as anemia; 5. Previous history of craniocerebral surgery, traumatic brain injury within the past 2 years (including concussion), or brain injury or skull fractures detected during baseline imaging examination, brain abscess, brain tumor, obstructive hydrocephalus (including acquired aqueductal stenosis and cancerous meningitis); 6. Currently receiving anticoagulant medication treatment or expected to receive anticoagulant medication treatment in the future; 7. Having experienced symptomatic cerebral infarction within 3 months (allowing for the occurrence of asymptomatic lacunar infarction); 8. Parkinson's syndrome, which complicates the assessment of the outcome; 9. Gait disorders unrelated to hydrocephalus, such as hemiplegia, spasticity, cerebellar ataxia, or musculoskeletal and joint disorders; 10. For those who are allergic to Xianbixin or who cannot tolerate it; 11. Researchers who dropped out midway.

Design outcomes

Primary

MeasureTime frame
iNPH Scale;

Secondary

MeasureTime frame
Metabolomics analysis;minimum mental state examination, MMSE;Montreal Cognitive Assessment;Activities of Daily Living (ADL);

Countries

China

Contacts

Public ContactYi Zhang

Tianjin Huanhu Hospital

103841540@qq.com+86 22 59065815

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026