Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients: Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- motor aspects of daily living
研究概览
简要总结
The goal of this clinical trial is to learn that metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson disease patients. Researcher will compare drug metformin to a placebo. Participants will take metformin or placebo for 8 weeks.
详细描述
This clinical trial is an effort to explore whether administration of metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson's disease patients. After completion of necessary formalities, each participant will be assessed by translated and validated Bangla version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part questionnaire and malondialdehyde (MDA) and glutathione (GSH) will be measured at baseline and after 8 weeks.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed mild to moderate PD patients taking Levodopa
- •Age 18 years and older
- •Sex : Any
排除标准
- •Secondary causes of Parkinsonism
- •Prior stereotactic surgery for PD
- •Suffering from active malignancy
- •Known hypersensitivity to metformin
- •Pregnancy or lactation
研究组 & 干预措施
Metformin- Patients receiving Levodopa with Metformin
Dosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks
干预措施: Metformin (Drug)
Control - Patients receiving Levodopa with Placebo
placebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks
干预措施: placebo (Other)
结局指标
主要结局
motor aspects of daily living
时间窗: 8 weeks
motor aspects of daily living in MDS-UPDRS rating scale (Movement Disorder Society- sponsored revision of the Unified Parkinson's Disease Rating Scale). The score of Part 2 of this scale i.e. motor experiences of daily living is 13.
次要结局
- 1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.(8 weeks)
- Comparison of adverse effects in percentage(8 weeks)
- 1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.(8 weeks)
研究者
RUKHSANA AKTER
Principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh