Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open-label clinical study where all new patients presenting with cerebrovascular accidents and consenting to treatment are given intravenously a new combination of medications. Patients are evaluated neurologically with NIHSS scores before treatment administration and at 1 month after the first treatment. Further evaluations at 6 months after treatment by NIHSS and Barthel scores are ongoing
Patients with cerebrovascular accidents (CVA), ischemic (including those with hemorrhagic transformation), are given a new combination of medications which aims to improve neuronal survival, stimulate mitochondrial genesis and the formation of new synapses. This combination is given as an intravenous perfusion with a 2-hr duration and consists of vitamins B1, B6, B12, C, Actovegin, etc.
Before treatment a NIHSS score is given. Each patient receives 3-4 such perfusions in 1 month and afterwards another NIHSS score is obtained.
Patients are monitored afterwards and those who show improvements receive more such treatments, and new NIHSS and Barthel scores are obtained.
Patients are grouped on the basis of the time interval between CVA occurence and first treatment:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Medication Combination | Experimental | Intervention: Combination Product: Perfusion with New Combination Medication Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perfusion with New Combination Medication | Combination Product | Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS differential | score differential on the National Institutes of Health Stroke Scale(NIHSS); total score is evaluated before treatment and 1 month after first treatment; NIHSS scores range between 0 (best score) and 42 (worst score); the differential quantifies an improvement in neurological function | 1 month after first administration of the combination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Felician Stancioiu | Fundatia Bio-Forum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundatia Bio-Forum | Bucharest | Bucharest | 040245 | Romania |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010477 | Perfusion |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
Not provided
Not provided
The new combination treatment is given to all consecutive patients and compared to literature and between groups (based on the time lapsed between CVA and treatment)
Not provided
Not provided
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |