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Completed

NCT Number: NCT07466381

Oxyhydrogen Nanobubble Infusion as a Complementary Therapy in Patients With Parkinsonism

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brawijaya University Hospital

Malang, East Java, 65141, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

oxyhydrogen nanobubble infusion

Drug

H2 and O2 gas molecules encapsulated in nanobubbles

Primary outcomes

  1. parkinsonism severity level

    Time frame: 2 months

    parkinsonism severity level based on Hoehn and Yahr scale, from range 0 to 5, where a higher score indicates severe parkinsonism level

  2. cognitive function

    Time frame: 2 months

    cognitive function by using Montreal Cognitive Assessment (Indonesia version), from range 0 to 30, where a lower score indicates more cognitive declining

  3. quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

dr. Siti Nurlaela, SpN

Other

Registry information

Acronym: OHNB

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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