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The clinical manifestations of Parkinson's disease (PD), a chronic neurodegenerative condition, include resting tremor, hypokinesia, bradykinesia, stiffness and postural instability. These motor symptoms are caused by a selective loss and degeneration of dopaminergic neurons in the substantia nigra pars compacta (SNpc) region, which leads to a dopamine (DA) insufficiency in the striatum
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Control group (Levo-dopa group, n =30) who will receive levodopa/carbidopa (125/12.5 mg) three times daily for 6 months |
|
| Vinpocetine group | Active Comparator | Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus vinpocetine 10 mg three times daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levodopa Carbidopa | Drug | Carbidopa/levodopa, also known as levocarb and co-careldopa, is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in The Unified Parkinson's Disease Rating Scale (UPDRS). | The unified Parkinson's disease rating scale is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes in serum biomarkers | The secondary endpoint is estimated by changes in serum biomarkers such as α-synuclein and Toll like receptor 4 | 6 months |
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Inclusion Criteria:
Age ≥ 50 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa
Exclusion Criteria:
Secondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Cardiovascular disease patients Patients with coagulation disorders Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta Unuversity | Recruiting | Tanta | 31527 | Egypt |
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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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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
| C013983 | vinpocetine |
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Double blinded
| Vinpocetine | Drug | VIN, a phosphodiesterase-1 (PDE1) inhibitor, reduces oxidative stress and neuroinflammation and is used clinically for cerebrovascular disease and dementia. In PD, VIN increases dopamine levels, protects dopaminergic neurons, reverses motor impairments, and reduces inflammatory mediators |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |