Spinal cord injury. multiple fractures of spine, level unspecified
Conditions
Interventions
Intervention 1: Intramuscular injection of 5 mg Progesterone twice daily up to 5 days + 0.5 mg Vitamin D3 orally twice daily for 5 days. Intervention 2: Intramuscular injection of normal saline twice
Treatment - Drugs
Intramuscular injection of 5 mg Progesterone twice daily up to 5 days + 0.5 mg Vitamin D3 orally twice daily for 5 days
Intramuscular injection of normal saline twice a day for 5 days + oral placebo tablets twice a day for 5 days
Sponsors
Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age between 18 and 65 years; giving informed written consents; traumatic acute spinal-cord injury; being randomized within 8 hours of the injury. Exclusion criteria: Age less than 18 or more than 65 years; involvement of the nerve root; cauda equina only; gunshot wounds; life-threatening morbidity; those who were pregnant; addicted to narcotics; receiving maintenance steroids for other reasons; those who had received more than 100 mg of methylprednisolone or its equivalent, or 1 mg of naloxone before admission to the center; those in whom follow-up would be difficult; pure sensory loss; complete motor deficit; randomization >8 hours after injury.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscular force of the effected limbs. Timepoint: 24-hour, 6 days, 3 months. Method of measurement: International Standards for Neurological Classification of Spinal Cord Injury. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensory level. Timepoint: 24-hour, 6 days, 3 months. Method of measurement: Pinprick and Light Touch. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Asna Ashari
Isfahan University of Medical Sciences
Outcome results
None listed