Clinical Study to Evaluate Safety and Effectiveness of Vinpocetine in Patients With Parkinsonian Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in The Unified Parkinson's Disease Rating Scale (UPDRS).
研究概览
简要总结
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
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
- Double (Participant, Care Provider)
盲法说明
Double blinded
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years Both male and female will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa
排除标准
- •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
研究组 & 干预措施
Vinpocetine group
Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus vinpocetine 10 mg three times daily for 6 months
干预措施: Vinpocetine (Drug)
Control group
Control group (Levo-dopa group, n =30) who will receive levodopa/carbidopa (125/12.5 mg) three times daily for 6 months
干预措施: Levodopa Carbidopa (Drug)
Vinpocetine group
Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus vinpocetine 10 mg three times daily for 6 months
干预措施: Levodopa Carbidopa (Drug)
结局指标
主要结局
Change in The Unified Parkinson's Disease Rating Scale (UPDRS).
时间窗: 6 months
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.
次要结局
- changes in serum biomarkers(6 months)