Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease

Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease - Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010014

Enrollment

200

Registered

2013-02-13

Start date

2013-02-28

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&#39

Interventions

hydrogen water made by &quot

Suisosui5.0&quot

placebo-water (nitrogen filling water)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects had received the diagnosis of PD according to the United Kingdom Brain Bank criteria. 2) No change on medication, levodopa, dopamin agonist, and other limited drugs for eight weeks. 3) Modified Hoehn and Yahr staging (H&Y stage) on on-phase under 4. 4) Without dementia (MMSE >= 25). 5) Without dysphagia for water. 6) Outpatients are better than admitted patietns. 7) The subjects are over 20 years-old. 8) Written informed consent must be obtained.

Exclusion criteria

Exclusion criteria: 1. The patient has parkinsonism due to corticobasal syndrome, multiple system atrophy, drug parkinsonism, hydrocephalus, or essential tremor. 2. The presence of other serious disease. 3. The presence of malignant tumor. 4. The presence of adverse event caused by levodopa or dopamine agonist. 5. Pregnant woman 6. Allergy for drugs. 7.The subjects who is inappropriate for the study according to our judgment.

Design outcomes

Primary

Measure	Time frame
The primary endpoint with efficacy in PD was the change of total score of UPDRS(I~IV) from baseline to the 72th week.	—

Secondary

Measure	Time frame
Additional analysis 1.The change of total UPDRS part II, III, each scores, and modified Hoehn and Yahr staging from baseline to 8th, 24th, 48th, and 72th weeks and post 8th weeks. The changes of total score of UPDRS from baseline to 8th, 24th, 48th and post 8th week. 2.The change of total PDQ39, each scores, and subtotal scores. 3.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 total UPDRS part II, III, each scores, and modified Hoehn and Yahr staging from baseline to 8th, 24th, 48th, and 72th weeks and post 8th weeks. The changes of total score of UPDRS from baseline to 8th, 24th, 48th and post 8th week. 2.The change of total PDQ39, each scores, and subtotal scores. 3.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 ContactShimo Y, Hatano T, Ohyama G, Ando M, Yoritaka A.

Juntendo University School of Medicine Neurology

ayori@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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