CTRI/2009/091/000893.

Trial name or title	A randomized placebo controlled trial of progesterone with or without hypothermia in subjects with acute severe traumatic brain injury
Methods	RCT
Participants	Inclusion criteria: men or women aged 18‐65 years with suspected TBI; GCS score 4‐8 after resuscitation and stabilisation, who arrived within 8 hours of injury Exclusion criteria: people who have received any investigational drugs 30 days prior to enrolment, such as progesterone, oestrogen or any other investigational compound; people with severe anoxic intracerebral damage or brain death; those whose clinical condition is unstable (partial pressure of oxygen ≤60 mmHg or a systolic blood pressure ≤90 mmHg, or both); pregnant or lactating women; those for whom there is doubt about whether the altered neurological status resulted from head trauma or acute or chronic spinal cord injury
Interventions	Intervention group: progesterone 1.0 mg/kg via intramuscular injection, repeated every 12 hours for 5 consecutive days Control group: distilled water 1.0 mg/kg via intramuscular injection, repeated every 12 hours for 5 consecutive days
Outcomes	Primary outcome: GOS score at 1, 3 and 6 months Secondary outcomes: FIM score and mortality at 1,3 and 6 months
Starting date	January 2012
Contact information	Dr Sumit Sinha, sumitaiims@yahoo.com Department of Neurosurgery, JPNA Trauma Center, All India Institute of Medical Sciences‐110029 New Delhi, DELHI
Sponsors and Collaborators	Department of Biotechnology, Government funding agency
Notes	Estimated enrolment: 250 participants