Oxyhydrogen Nanobubble Infusion as a Complementary Therapy in Patients With Parkinsonism (OHNB)

dr. Siti Nurlaela, SpN

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: oxyhydrogen nanobubble infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07466381

291/EC/KEPK/08/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

participant

Experimental group

Description:

oxyhydrogen nanobubble infusion

Treatment:

Drug: oxyhydrogen nanobubble infusion