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Effect of progestrone on head injury

Evaluation of improved outcomes from the administration of progesterone after severe traumatic brain injury

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012080810536N1
Enrollment
48
Registered
2012-12-01
Start date
2012-10-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Head injury. Intracranial injury

Interventions

Intervention 1: For patients in the intervention group administrated 1 mg / kg every 12 hours for up to 3 days of progesterone as IM injection. Intervention 2:  For patients in control group, progest
Treatment - Drugs
For patients in the intervention group administrated 1 mg / kg every 12 hours for up to 3 days of progesterone as IM injection.
For patients in control group, progestrone not will be administratedAssesment of patients carry out according to GOS and FIM, one  and three months after third day after admidet in hospital.

Sponsors

Islamic Azad University Najaf Abad
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: all male and female patients 18 years and more with admission GCS 8-4 during the first 8 hours on a voluntary and informed consent Exclusion criteria: injuries incompatible with life; bilateral dilated and no response to light pupils; spinal cord injury with neurological deficit; cardiopulmonary arrest; status epilepticus on arrival; initial systolic blood pressure less than 90; initial oxygen saturation less than 90%; pregnant women; any known previous or current cancer; known sensitivity to progesterone; known Coagulation disorders and lack of desire to continue research.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Score. Timepoint: One and three mounths after intervention. Method of measurement: GOS.;Functional Independence Measure. Timepoint: One and three mounts after intervention. Method of measurement: FIM.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMajid Kalbasi

Islamic Azad University Najaf Abad

kalbasimajid@gmail.com+98 31 1626 5002

Outcome results

None listed

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