Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2017-08-08
2018-09-29
Brief Summary
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Detailed Description
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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:
* Group 1: 0-35 days
* Group 2: 36-100 days
* Group 3: 101-360 days Improvement of motor function is compared using NIHSS scores between groups, and between literature and groups
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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New Medication Combination
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* agreeing to treatment in person or by proxy signing of Informed Consent Form
* available for NIHSS evaluation
Exclusion Criteria
* scheduled for surgery or other procedures
* not available for NIHSS evaluation after at least 48 hours from treatment
18 Years
80 Years
ALL
No
Sponsors
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Fundatia Bio-Forum
OTHER
Responsible Party
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Principal Investigators
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Felician Stancioiu
Role: PRINCIPAL_INVESTIGATOR
Fundatia Bio-Forum
Locations
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Fundatia Bio-Forum
Bucharest, București, Romania
Countries
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Other Identifiers
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PSIOM
Identifier Type: -
Identifier Source: org_study_id
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