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A randomized controlled study for dl-3n-butylphthalide in the treatment of Cerebral Circulation Disorder and inflammatory stress response in TBI patients

A randomized controlled study for dl-3n-butylphthalide in the treatment of Cerebral Circulation Disorder and inflammatory stress response in TBI patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022798
Enrollment
Unknown
Registered
2019-04-26
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

traumatic brain injury

Interventions

Experimental group:25 mg of NBP administered intravenously, twice daily, 10 days + conventional treatment
Control Group:conventional treatment

Sponsors

Changzhou Wujin People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: History of brain injury; aged 18 to 70 years (inclusive); admission within the first 24 hours after injury; isolated TBI with subarachnoid hemorrhage confirmed by head CT or MRI examination; symptoms such as headache, nausea, vomiting, disturbance of consciousness, or meningeal irritation.

Exclusion criteria

Exclusion criteria: A nonsurvivable brain injury; other primary diagnosis such as subdural hematoma, epidural hematoma or contusion; polytrauma, defined as greater than 1 nonhead body region with Abbreviated Injury Severity (AIS) score greater than 3; pregnant or lactating women; history of severe cardiac and pulmonary diseases; severe mental retardation or prior severe brain injury; previous enrollment in any other clinical trial.

Design outcomes

Primary

MeasureTime frame
Cerebral blood volume;Cerebral blood flow;Mean transmit time;Velocity of middle cerebral artery;IL-1ß level of blood sample;IL-6 level of blood sample;TNFa level of blood sample;IL-1ß level of CSF;IL-6 level of CSF;TNFa level of CSF;

Countries

China

Contacts

Public ContactJin Peng

Changzhou Wujin People's Hospital

1539768858@qq.com+86 13915073222

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026