Effect of Folic Acid on Motor Aspects of Daily Living and Oxidative Stress in Levodopa Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of folic acid on motor aspects of daily living in levdopa treated of Parkinson's disease patients
研究概览
简要总结
This is a prospective single center, randomized, double-blind, 2 arm placebo-controlled study in subjects with Parkinson's disease receiving levodopa .The patients will be randomized to receive tablet Folic Acid 10 mg per day or placebo for 8 weeks. The safety and efficacy outcome measures will be assessed at baseline and 8 weeks.
详细描述
Parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. Most commonly used drug, levodopa can improve the dopamine level in brain but levodapa causes hyperhomocysteinmia as a result increse neurotoxicity,oxidative stress and motor fluctuations and dyskinesia in many patients. Folic acid has been reduced homocystein level in levodopa treated Parkinson's disease on animal model and also reduced Levodopa induced dyskinesia without compromising the motor benefits of Levodopa. Therefore, the present study is to attempt to improve the sign symptoms of Parkinson's disease by giving folic acid along with Levodopa.
This study is a Randomized, Double-Blind, Placebo-Controlled Trial and conducting at Department of Pharmacology, BSMMU in collaboration with Department of Neurology, BSMMU. A total of 60 patients suffering from Parkinson's disease is selected according to inclusion and exclusion criteria. The diagnosis of the patients suffering from Parkinson's disease will be performed by a neurologist at movement disorder clinic of department of Neurology, BSMMU. Patients will undergo MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to assess the severity of the disease. The patients will be randomly allocated into two arms: control and intervention. Patients in intervention arm consisted of 30 patients who will receive levodopa plus folic acid orally for 8 weeks. On the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. The severity of Parkinson's disease will be assessed 8 weeks follow up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed PD patients taking levodopa for at least 6months.
- •Mild to moderate Parkinson's disease patient according to Hoehn and Yahr staging, stage -I, II, III
- •Homocysteine level ≥ 13 µmol/L
排除标准
- •Secondary causes of parkinsonism
- •Prior stereotactic surgery for PD
- •Suffering from active malignancy
- •Known hypersensitivity to folic acid
- •Multivitamin supplementation within 30 days of enrollment
- •Patients taking anticonvulsant, oral contraceptive pill, disease modifying anti-rheumatic drugs
- •Pregnancy or lactating mother
- •Has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed
研究组 & 干预措施
Folic acid
30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
干预措施: Folic Acid Tablet (Drug)
Control
30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Effect of folic acid on motor aspects of daily living in levdopa treated of Parkinson's disease patients
时间窗: 8 weeks
Assessing and comparing the severity of symptoms of Parkinson's disease of two groups by using MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at baseline and 8 weeks following folic acid and placebo supplementation.
次要结局
- Serum homocysteine(8weeks)
- Serum malondialdehyde level(8weeks)
- Serum glutathion(8weeks)
研究者
Dr. Shimu Akter Ayshi
MD Resident
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh