IRCT2014042017356N1.

Trial name or title	Effect of female sex hormones on traumatic brain injury
Methods	RCT
Participants	Inclusion criteria: diffuse TBI; men aged 18‐60 years with moderate to severe brain injury (GCS grades 3‐8 = severe and 9‐12 = moderate). Exclusion criteria: people with blunt head trauma; damage at an unknown time; entering the hospital > 4 hours after the time of damage; severe hypothermia (temperature less than 28 °C); aged < 18 years and > 60 years; candidates for craniotomy; diseases related to the immune system, gastrointestinal, oncology, infectious diseases, and other associated trauma
Interventions	Intervention 1 (control group): routine and standard treatment only Intervention 2 (progesterone group): in addition to routine and standard treatment, within 4 hours of brain damage participants are given progesterone 1 mg/kg intramuscularly; dose is repeated every 12 hours for 5 consecutive days Intervention 3 (oestrogen group): in addition to routine and standard treatment, within 4 hours of brain damage participants are given a 40 µg oral oestrogen dose; dose is repeated daily for 5 consecutive days
Outcomes	CRS‐R , FIM, GOS‐E, complications and adverse effects, difference GCS between admission and discharge times, length of stay, mortality
Starting date	May 2014
Contact information	Dr Mohammad Khaksari, physiolojy@kmu.ac.ir. Department of Physiology, Afzalipour Medicine College, 22 Bahman Blvd. Kerman, Islamic Republic of Iran.
Sponsors and Collaborators	Kerman Neuroscience Research Center
Notes	Estimated enrollment: 90 participants

Abbreviations

CRS‐R: coma recovery scale ‐ revised
 CT: computed tomography
 FIM: Functional Independence Measure
 GCS: Glasgow Coma Scale
 GOS: Glasgow Outcome Scale
 GOS‐E: extended Glasgow Outcome Scale
 ICP: intracranial pressure
 ITT: intention‐to‐treat analysis
 RCT: randomised controlled trial
 SF‐36: Short Form (36) health survey
 TBI: traumatic brain injury