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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number:2006-000491-33 |
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The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treated with levodopa/carbidopa.
Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high number of patients develop motor complications, including, fluctuations and dyscinesia after some years of treatment.
The origin of the fluctuations is not well established, but it could be attributed, al least partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the adverse reaction if we reach more stable levels of L-dopa in the circulation. The first experimental studies in animals showed that Plantago ovata husk has an influence in the pharmacokinetics parameters of L-dopa, obtaining more stable levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Plantago ovata husk |
|
| 2 | Placebo Comparator | hemicellulose crystalline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plantago ovata husk | Drug | 5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To study how the fiber Plantago ovata husk modifies the pharmacokinetics parameters of the absorption and elimination of L-dopa. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate if the treatment with Plantago ovata husk modifies the biochemical parameters as total cholesterol, HDL y LDL, glycaemia, etc. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sierra Matilde, Ph, phD | Departamento de Ciencias Biomédicas de la Facultad de Veterinaria de la Universidad de León, León (Spain) | Study Chair |
| Carriedo Demetrio, MD | Hospital de León, León (Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de León | León | León | 24071 | Spain |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| hemicellulose crystalline | Other | 5g effervescent powder t.id. during 14 days |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |