International Trial of Efficacy of Cytoflavin in Head Trauma
Status:
Recruiting
Trial end date:
2022-12-16
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company