None listed
Conditions
Brief summary
The purpose in this clinical study was to evaluate the effects of progesterone on functional outcome of the patients with severe head injury. Progesterone, a hormone, has steroidal, neuroactive and neurosteroidal action in the center neuronal system. Recently, neuroprotective effects of progesterone have been shown in a variety of animal models including ischemic and traumatic brain insults models. Post-injury administration of progesterone in head injury subjects confers significant protection against injury-induced cerebral edema and secondary neuronal death, promoting behavioral recovery.
Interventions
Progesterone were administered at 1.0mg/kg via intramuscular injection at admission immediately and then once per 12h for 5 consecutive days respectively.
Sponsors
the Affiliated Hospital, School of Medicine, Hangzhou Normal University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
severe traumatic brain injury , Glasgow Coma Scale (GCS) score of 8 or less after resuscitation and stabilization and between the ages of 15 and 65 years were entered into the study.
Exclusion criteria
received any investigational drug; severe anoxic intracerebral damage or brain death; clinical condition was unstable; with pregnancy and female patients during lactation.
Outcome results
None listed