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

March 9, 2026 updated by: dr. Siti Nurlaela, SpN
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Malang, East Java, Indonesia, 65141
        • Brawijaya University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: participant
oxyhydrogen nanobubble infusion
Drug: oxyhydrogen nanobubble infusion
H2 and O2 gas molecules encapsulated in nanobubbles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months
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
2 months
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

dr. Siti Nurlaela, SpN

Investigators

  • Principal Investigator: Siti Nurlaela, SpN, Brawijaya University Hospital
  • Study Director: Akhmad Sabarudin, Prof., Indonesia Molecule Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291/EC/KEPK/08/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

parkinsonism level, cognitive function, and quality of life before and after treatment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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