Cytoflavin in the Complex Rehabilitation of Stroke Patients
Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation
Eligibility Criteria
Inclusion Criteria: Signed Patient informed consent form Men and women aged 40 to 80, inclusive. Ischemic stroke in the carotid area, or hemorrhagic stroke in the cerebral hemispheres, occurred in the previous 14-90 days before screening. Acute neuroimaging data (CT and/or MRI) do not contradict the clinical and topical diagnosis of stroke. The presence of a measurable neurological deficit in the motor or sensory area. Availability of rehabilitation potential, which is assessed by the specialists of the multidisciplinary team Modified Rankin score 3-4. The possibility to visit outpatient rehabilitation at the research center. Ability to understand and comply with protocol requirements. For women: consent to use reliable methods of contraception or absent reproductive potential. For men: consent to the use of adequate methods of contraception, or complete abstinence from sexual activity for the period of the study, or absent reproductive potential. Exclusion Criteria: Known hypersensitivity to any component of the study drug Severe visual and hearing impairments that prevent the implementation of study procedures. Severe spasticity (scored 3-4 by Ashworth scale). Impaired swallowing, which does not allow taking drugs orally. Communication deficit that does not allow the patient to fulfill the conditions of the study protocol (including total aphasia). The presence of contraindications to complex rehabilitation in a hospital (lack of rehabilitation potential, somatic diseases that prevent a complex of rehabilitation measures). Aneurysmal subarachnoid hemorrhage. Previous (before the actual ictus) stroke with residual neurological deficit. Disability is primarily not attributed to the last stroke Severe renal failure Severe liver failure End stage of other chronic incurable diseases. Decompensated diabetes mellitus. History of cancer, mental illness, HIV infection, syphilis, tuberculosis, alcohol, drug or drug addiction. Established diagnosis of a mental or neurodegenerative disease Constant use of psychotropic drugs (neuroleptics, tranquilizers, antidepressants) or nootropic drugs in the previous 3 months before the patient was included in the study, except for stroke treatment in acute hospital. Alcohol or drug addiction 19. Pregnancy, lactation.
Sites / Locations
- City General Hospital №2Recruiting
- City Hospital №40 of the Kurortny DistrictRecruiting
- Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cytoflavin
Placebo