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This record is an additional copy of the study listed above
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The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPh201 group | Active Comparator | Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months |
|
| placebo group | Placebo Comparator | Patients will receive 400 microliter s.c., of saline twice a week for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPh201 | Dietary Supplement | Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in the awareness status of the patients. | Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation. | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in the awareness status of the patients. | clinical and fMRI assessment will be performed 1 month following treatment cessation | 1 month following the end of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamir Ben-Hur, MD PhD | Hadassah Medical Organization | Principal Investigator |
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| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline | Dietary Supplement | Patients will receive 400 microliter s.c., of saline twice a week for 3 months |
|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |