Oxyhydrogen Nanobubble Infusion as a Complementary Therapy in Patients With Parkinsonism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- parkinsonism severity level
研究概览
简要总结
The aim of this study was to determine the effect of oxyhydrogen nanobubble infusion on the degree of disease, cognitive function, and quality of life of patients with parkinsonism
详细描述
This study was conducted at Brawijaya University Hospital in Malang, Indonesia, involving 35 patients with parkinsonism. The study used a prospective cohort study design. The effects of oxyhydrogen nanobubble (OHNB) infusion on the subjects were observed without comparison to a control group (placebo). Pre- and post-test results were evaluated before and after the OHNB infusion.
The variables analyzed in this study were the degree of parkinsonism using the Hoehn and Yahr scale, cognitive function using the MOCA Ina test, and quality of life for patients with parkinsonism using the PDQ39 questionnaire.
The hypothesis of this study is that OHNB infusion can improve disease severity, cognitive function, and quality of life in patients with Parkinson's disease.
H2 and O2 gas molecules encapsulated in nanobubbles are more stable and can persist for longer periods in solution and more easily penetrate the blood-brain barrier. H2 nanobubbles have superior antioxidant properties than H2 water alone. These hydrogen nanobubbles have anti-inflammatory effects, thus reducing cellular inflammation, reducing oxidative stress and protecting the brain from ischemic injury, mitigating acute neurotoxic effects, and addressing behavioral disorders caused by MPTP exposure on dopaminergic neurons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study used a prospective cohort study design. The effects of oxyhydrogen nanobubble (OHNB) infusion on the subjects were observed without comparison to a control group (placebo). Pre- and post-test results were evaluated before and after the OHNB infusion.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the criteria for parkinsonism
- •18-70 years old
排除标准
- •Patient is unwilling to undergo examination.
- •Pregnancy.
- •History of malignancy and/or chemotherapy.
- •History of alcohol or drug use that can induce extrapyramidal symptoms.
- •Hyperthyroidism.
- •Impaired kidney function.
- •Impaired liver function.
- •Patients with heart failure requiring fluid restriction.
- •MRI results suggest a brain tumor causing parkinsonism symptoms.
- •Catalase enzyme deficiency (acatalasemia).
研究组 & 干预措施
participant
oxyhydrogen nanobubble infusion
干预措施: oxyhydrogen nanobubble infusion (Drug)
结局指标
主要结局
parkinsonism severity level
时间窗: 2 months
parkinsonism severity level based on Hoehn and Yahr scale, from range 0 to 5, where a higher score indicates severe parkinsonism level
cognitive function
时间窗: 2 months
cognitive function by using Montreal Cognitive Assessment (Indonesia version), from range 0 to 30, where a lower score indicates more cognitive declining
quality of life
时间窗: 2 months
quality of life based on The Parkinson's Disease Questionnaire (PDQ-39), from range 0 to 100, where a higher score indicates more difficulty and worse quality of life
次要结局
未报告次要终点
研究者
dr. Siti Nurlaela, SpN
neurologist
University of Brawijaya