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| Name | Class |
|---|---|
| Silpakorn University | OTHER |
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Dysphagia is a complication in patient with stroke, Parkinson's disease or dementia that can lead to aspiration pneumonia. This study aimed to investigate dysphagia improvement after treatment with nicergoline low dose and high dose, the relationship between nicergoline dose and clinical improvements, side effect of nicergoline and simulation optimal nicergoline dose in dysphagia improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicergoline low dose | Experimental | Nicergoline 10 mg bid (20 mg/day) |
|
| Nicergoline high dose | Experimental | Nicergoline 30 mg bid (60 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicergoline | Drug | The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group. | Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week. | 4 and 12 weeks |
| Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group. | Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week. | 4 and 12 weeks |
| Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state. | Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal nicergoline dose for dysphagia improvement. | Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement | 12 weeks |
| Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jutikan Imsub, PharmD | College of Pharmacy, Burapha university | Study Chair |
| Sittichoke Sirimontakan, MD | Phramongkutklao hospital and College of Medicine | Principal Investigator |
| Juthathip Suphanklang, BCP | Phramongkutklao hospital and College of Medicine | Study Director |
| Pasiri Sithinamsuwan, MD | Phramongkutklao hospital and College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramongkutklao Hospital | Ratchathewi | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| D010300 | Parkinson Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D009530 | Nicergoline |
| ID | Term |
|---|---|
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
Evaluated by clinical reported from patients and hospitalization data. |
| 12 weeks |
| Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group. | Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks. | 12 weeks |
| Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group. | Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks. | 12 weeks |
| Adverse side effect in low dose and high dose nicergoline treatment. | Blood sampling for renal function (including creatinine serum, creatinine clearance) and uric serum. Other adverse side effect reported by patients/care givers. | 4 and 12 weeks |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |