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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 |
|
| Metformin group | Active Comparator | Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus metformin 500 mg two 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 |
|---|---|---|
| Change in PDQ-39 | The Parkinson's Disease Questionnaire-39 (PDQ-39) is a widely recognized, disease-targeted, self-administered tool that captures patients' perspectives on how Parkinson's disease influences their health-related quality of life | 6 months |
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Inclusion Criteria:
Eligible participants were men and women aged 50 years or older with a confirmed diagnosis of PD Patients receiving levodopa/carbidopa therapy.
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 University | Recruiting | Tanta | 31511 | 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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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Double blinded
| Metformin | Drug | Metformin, sold under the brand name Glucophage, among others, is the main first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight. |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |