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Investigating the effect of indomethacin on the clinical outcome of patients with severe non-hemorrhagic traumatic brain injury, a randomized placebo-controlled study

Investigating the effect of indomethacin on the clinical outcome of patients with severe non-hemorrhagic traumatic brain injury, a randomized placebo-controlled study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220521054939N1
Enrollment
30
Registered
2022-12-14
Start date
2022-07-06
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Traumatic brain injury. Concussion

Interventions

Intervention 1: Intervention group: Indomethacin in the amount of 25 mg for 5 days will be administered intravenously in an initial loading dose of 0.8 mg/kg in 100 cc of normal saline solution over 1

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: Registration of informed consent of the first degree patient to participate in the study Age 16 to 70 years Severe traumatic brain injury with closed or penetrating mechanism High resistant ICP 8 =GCS

Exclusion criteria

Exclusion criteria: Pregnancy Brain death Coagulation disorders History of gastrointestinal bleeding or active bleeding History of peptic ulcer Acute kidney injury History of allergies to nonsteroidal anti-inflammatory drugs Clinical signs and symptoms of renal failure or its history Hyperkalemia Liver failure

Design outcomes

Primary

MeasureTime frame
Severe traumatic brain injury. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
Degree of disability or dependence in daily activities. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale.;Severe traumatic brain injury. Timepoint: It will be measured again one month and 6 months after administration. Method of measurement: Visual Analogue Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Ehteshami

Mazandaran University of Medical Sciences

s.ehteshami@ mazums.ac.ir+98 11 3336 1630

Outcome results

None listed

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