The Study of Efficacy on Low Dose Nicergoline in Dysphagia Patients Compares With High Dose Nicergoline.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 20 years
- •Stroke (post events at least 2 months), Parkinson's disease and dementia patients who have dysphagia symptom
- •Do not take nicergoline prior recruit 2 weeks
- •Continue current medications
- •Consent to join
排除标准
- •Allergy to gentamicin or components
- •On anticoagulants including Heparin, Enoxaparin, Fondaparinux, Warfarin, Dabigatran, Apixaban, Rivaroxaban and Edoxaban
- •On antiplatelet > 1 drug (ex. dual antiplatelet)
- •On ACE-I or Dopaminergic agent 2 months or less
- •Chronic dyspepsia
- •Chronic gout or hyperuricemia > 8 mg/dL
- •CrCl < 30 ml/min
- •Impair hepatic function including child puge B, C or active hepatitis
- •Brainstem stroke
- •Parkinson plus syndrome: PSP, MSA, DLB, etc
- •Advanced cancer or other medical conditions
- •Bed ridden
- •Laryngopharynx surgery
- •SBP<100 or DBP 60 mmHg
- •HR<50/min
- •Active bleeding
- •Pregnancy or lactation
- •Known of poor compliance for any treatments
研究组 & 干预措施
Nicergoline low dose
Nicergoline 10 mg bid (20 mg/day)
干预措施: Nicergoline (Drug)
Nicergoline high dose
Nicergoline 30 mg bid (60 mg/day)
干预措施: Nicergoline (Drug)
结局指标
主要结局
Rate of dysphagia improvement in low dose nicergoline compare with high dose nicergoline group.
时间窗: 4 and 12 weeks
Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.
Rate of dysphagia improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.
时间窗: 4 and 12 weeks
Dysphagia improvement evaluated by physician with GUSS method after nicergoline administration in 4 and 12 week.
Relation between MDL level, substanceP and dysphagia improvement after nicergoline administration both groups (low dose and high dose) in steady state.
时间窗: 4 weeks
Blood sampling for MDL level in Ctrough, Cpeak and substanceP at steady state of nicergoline effect.
次要结局
- Rate of cognitive function improvement in low dose nicergoline and high dose nicergoline group compare pre and post nicergoline treatment each group.(12 weeks)
- Incidence of aspiration pneumonia in low dose nicergoline compare with high dose nicergoline group.(12 weeks)
- Optimal nicergoline dose for dysphagia improvement.(12 weeks)
- Adverse side effect in low dose and high dose nicergoline treatment.(4 and 12 weeks)
- Rate of cognitive function improvement in low dose nicergoline compare with high dose nicergoline group.(12 weeks)