Clinical Study Evaluating the Possible Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
Parkinson's disease (PD) is a leading neurodegenerative movement disorder, marked by a gradual loss of dopamine-producing neurons in the substantia nigra pars compacta (SNpc) and the accumulation of α-synuclein protein aggregates. Silymarin, a polyphenolic flavonoid renowned for its potent antioxidant properties, will be studied for its neuroprotective effects in PD.
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, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 65 years old
- •Both sexes
- •Patients with Parkinson's disease on dopamine replacement therapy
- •Modified Hoehn and Yahr stage, MHY 1-4 (29)
排除标准
- •Subjects < 18 years of age
- •Pregnant or breastfeeding women
- •Suspected hypersensitivity to silymarin or multivitamins
- •Advanced liver disease (e.g., ascites, bleeding esophageal varices, and hepatic encephalopathy)
- •Subjects with morbid obesity, i.e., a Body Mass Index (BMI) > 40
- •Subjects with severe illness, e.g., multisystem failure, cancer, or poorly controlled diabetes, i.e., known diabetic with Hemoglobin A1C (HbA1C)>7%
- •Current use of Silymarin or recent use within the past two weeks.
- •Other conditions, which, in the opinion of the investigators, make the patient unsuitable for enrollment.
研究组 & 干预措施
Silymarin group
25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months
干预措施: Silymarin (Drug)
Control group
25 patients who will receive their standard dopamine replacement therapy for 6 months
干预措施: levodopa-carbidopa (Drug)
Silymarin group
25 patients who will receive their standard dopamine replacement therapy plus silymarin 140mg three times daily for 6 months
干预措施: levodopa-carbidopa (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: 6 months
The Unified Parkinson's Disease Rating Scale (UPDRS) is a rating tool used to determine the severity and progression of Parkinson's disease in patients
次要结局
未报告次要终点
研究者
Nour Amr Ahmed Mosaad Elsherbeny
Teaching Assistant
Tanta University