Trial of molecular hydrogen water in Parkinson disease

Trial of molecular hydrogen water in Parkinson disease - Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007497

Enrollment

Registered

2012-03-14

Start date

2010-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks. Placebo water which is not contained molecular hydrogen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria required that subjects had received the diagnosis of PD according to the UK Brain Bank criteria , and had rating in the modified Hoehn and Yahr staging between 1 to 4 on on-phase, and medicated with levodopa, without dementia (MMSE >= 25). Outpatients are better than admitted patietns. No change on medication for PD for four weeks. The subjects are over 20 years-old.Written informed consent must be obtained.

Exclusion criteria

Exclusion criteria: 1. The patient with parkinsonism due to corticobasal syndrome, multiple system atrophy, drug parkinsonism, hydrocephalus, essential tremor. 2. The presence of other serious disease. 3. The presence of malignant tumor. 4. The presence of adverce event caused with dopaminagonist 5. Subjects which are inappropriate for the study according to our judgment.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change from baseline to 48th week in the total score of the Unified Parkinson 's disease Scale (UPDRS).	—

Secondary

Measure	Time frame
Additional analysis 1.The change of UPDRS part II, III, and Hoehn and Yahr staging from baseline to 8, 24, 48 weeks and post 8th weeks. The changes of total score of UPDRS from baseline to 8th, 24th, and post 8th week. 2. The duration to protocol ended because of addition of levodopa or progression of disease. Safety analysis 1) Adverse events except dyskinesia. 2) Screening laboratory studies included level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholestrol, HDL-cholestrol and triglyceride.	—

Measure

Time frame

Additional analysis 1.The change of UPDRS part II, III, and Hoehn and Yahr staging from baseline to 8, 24, 48 weeks and post 8th weeks. The changes of total score of UPDRS from baseline to 8th, 24th, and post 8th week. 2. The duration to protocol ended because of addition of levodopa or progression of disease. Safety analysis 1) Adverse events except dyskinesia. 2) Screening laboratory studies included level of total protein, albumin, alkaline phosphatase, aspartate transaminase, alanine transaminase, serum urea nitrogen, calcium, chloride, creatinine, glucose, lactate dehydrogenase, potassium, sodium, creatinine kinase, uric acid, choline esterase, LDL-cholestrol, HDL-cholestrol and triglyceride.

—

Countries

Japan

Contacts

Public ContactAsako Yoritaka

Juntendo University School of Medicine Neurology

+813-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026