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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000010014
• Date of registration: 13/02/2013
• Prospective Registration: Yes
• Primary sponsor: Juntendo University School of Medicine, Neurology
• Public title: Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease
• Scientific title: 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
• Date of first enrolment: 2013/02/28
• Target sample size: 200
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010386
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Asako Yoritaka
• Affiliation: Juntendo University Koshigaya Hospital Neurology

• Name: Shimo Y, Hatano T, Ohyama G, Ando M, Yoritaka A.
• Affiliation: Juntendo University School of Medicine Neurology

Key inclusion & exclusion criteria

Inclusion 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.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinson's disesase

Intervention(s)

hydrogen water made by "Suisosui5.0"
placebo-water (nitrogen filling water)

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Source(s) of Monetary Support

None

Ethics review

Status: YES
Approval date:
Contact: