Parkinson Disease
Conditions
Keywords
oxyhydrogen nanobubbles, parkinson
Brief summary
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
Detailed description
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.
Interventions
DRUGoxyhydrogen nanobubble infusion
H2 and O2 gas molecules encapsulated in nanobubbles
Sponsors
dr. Siti Nurlaela, SpN
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who meet the criteria for parkinsonism * 18-70 years old
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| parkinsonism severity level | 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 | 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 | 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 |
Countries
Indonesia
Contacts
PRINCIPAL_INVESTIGATORSiti Nurlaela, SpN
Brawijaya University Hospital
STUDY_DIRECTORAkhmad Sabarudin, Prof.
Indonesia Molecule Institute
Outcome results
None listed