Oxyhydrogen Nanobubble Infusion as a Complementary Therapy in Patients With Parkinsonism

NCT07466381 | Completed Phase 2 DMC

• 1 other identifier: 291/EC/KEPK/08/2024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

oxyhydrogen nanobubbles; parkinson

Outcome Measures

Primary Outcomes (3)

• parkinsonism severity level

  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

  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

  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

Study Arms (1)

participant

EXPERIMENTAL

oxyhydrogen nanobubble infusion

Drug: oxyhydrogen nanobubble infusion

Interventions

oxyhydrogen nanobubble infusion DRUG

H2 and O2 gas molecules encapsulated in nanobubbles

participant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet the criteria for parkinsonism
• years old

You may not qualify if:

• 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).

Sponsors & Collaborators

• dr. Siti Nurlaela, SpN: lead

Study Sites (1)

Brawijaya University Hospital

Malang, East Java, 65141, Indonesia

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Siti Nurlaela, SpN

  Brawijaya University Hospital

  PRINCIPAL INVESTIGATOR

• Akhmad Sabarudin, Prof.

  Indonesia Molecule Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: neurologist

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: March 12, 2026
• Study Start: November 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)