The study will access the efficacy and safety of treatment with CITOFLAVIN® in patients with non-penetrating moderately severe traumatic brain injury (TBI). The study recruits patients 18-60 years with TBI, corresponding to the clinical diagnosis of brain contusion, with GCS score 9 -14 at the time of inclusion , with the estimated time of initiation of therapy within 24 hours from the estimated or established time of trauma, with post-traumatic amnesia, confusion or disorientation and absence of indications for neurosurgery or other surgical intervention under general anesthesia. Cytoflavin® (Inosine + Nicotinamide + Riboflavin + Succinic Acid) is a combination drug, which improves cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improvement of cognitive functions of the brain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
166
20 ml (2 ampoules, 10 ml each) dissolved in 200 ml of 0.9% sodium chloride, intravenously 2 times a day with an interval of 12 ± 2 hours, for 10 days.
20 ml of 0.9% sodium chloride (2 ampoules of 10 ml each), added to 200 ml of 0.9% sodium chloride, intravenously 2 times a day with an interval of 12 ± 2 hours, for 10 days
West Kazakhstan Medical University named after. M. Ospanov
Aktobe, Kazakhstan
Ivanovskaya Regional Clinical Hospital
Ivanovo, Russia
City Clinical Hospital No. 67 named after L.A. Vorokhobov
Moscow, Russia
Research Institute of Emergency Medicine n.a. N.V. Sklifosovsky
Moscow, Russia
Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod, Russia
City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, Russia
Stavropol Regional Clinical Hospital
Stavropol, Russia
State Autonomous Healthcare Institution of the Sverdlovsk Region "Central City Clinical Hospital No. 23"
Yekaterinburg, Russia
Galveston Orientation and Amnesia scale
The proportion of patients with regression of post-traumatic amnesia by day 7 of treatment, defined as having a Galveston score of \>75 points on 3 consecutive days, up to and including day 7 of treatment.
Time frame: 7 days
Glasgow Outcome scale - Extended (GOS-E)
Assessment by GOS-E after 3 months
Time frame: 90 days
Glasgow Coma Scale
Daily assessment by GCS for the period up to 14 days of the study
Time frame: 14 days
Barthel Index
Assessement of Barthel Activities of daily living Index on day 14 or discharge, whatever earlier
Time frame: 14 days
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