Oxyhydrogen Nanobubble Infusion as a Complementary Therap... | NCT07466381

Studies
Oxyhydrogen Nanobubble Infusion as a Complementary Therapy in Patients With Parkinsonism

NCT07466381

Sponsor

dr. Siti Nurlaela, SpN

Status

Completed

Last Update Posted

Mar 12, 2026Actual

Enrollment

35Actual

Phase

Phase 2Phase 3

Conditions

Parkinson Disease

Interventions

oxyhydrogen nanobubble infusion

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Nov 30, 2025Actual

Completion Date

Jan 31, 2026Actual

First Submitted Date

Sep 3, 2025

First Submission Date that Met QC Criteria

Mar 9, 2026

First Posted Date

Mar 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

dr. Siti Nurlaela, SpN, neurologist, University of BrawijayaSponsor-Investigator

Lead Sponsor

dr. Siti Nurlaela, SpNOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
participant	Experimental	oxyhydrogen nanobubble infusion	Drug: oxyhydrogen nanobubble infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxyhydrogen nanobubble infusion	Drug	H2 and O2 gas molecules encapsulated in nanobubbles	participant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Siti Nurlaela, SpN	Brawijaya University Hospital	Principal Investigator
Akhmad Sabarudin, Prof.	Indonesia Molecule Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brawijaya University Hospital		Malang	East Java	65141	Indonesia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 18, 2024	Oct 16, 2025	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.

Masking Info

Masking

None (Open Label)

Masking Description

Who Masked

Not provided