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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The participants in both arms will receive nicergoline for treatment dysphagia 12 weeks.
Phramongkutklao Hospital
Ratchathewi, Bangkok, Thailand
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks
Optimal nicergoline dose for dysphagia improvement.
Simulated optimal nicergoline dose by Monte Carlo method with Ctrough, Cpeak and dysphagia improvement
Time frame: 12 weeks
Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.
Evaluated by clinical reported from patients and hospitalization data.
Time frame: 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.
Time frame: 12 weeks
Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
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Evaluated by physician with MMSE-Thai 2002 after nicergoline administration in 12 weeks.
Time frame: 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.
Time frame: 4 and 12 weeks