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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007497
Receipt No. R000008832
Scientific Title Trial of molecular hydrogen water in Parkinson disease
Date of disclosure of the study information 2012/03/14
Last modified on 2013/01/07

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Basic information
Public title Trial of molecular hydrogen water in Parkinson disease
Acronym Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease
Scientific Title Trial of molecular hydrogen water in Parkinson disease
Scientific Title:Acronym Randomized Double-blind, Placebo-controlled trial on molecular hydrogen water in Parkinson Disease
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine that intake of molecular hydrogen water is safe and a disease-modifying treatment of PD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint is the change from baseline to 48th week in the total score of the Unified Parkinson 's disease Scale (UPDRS).
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks.
Interventions/Control_2 Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.



Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asako Yoritaka
Organization Juntendo University School of Medicine
Division name Neurology
Zip code
Address Bunkyo-ku Hongo 3-1-1, Tokyo, Japan
TEL +813-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Asako Yoritaka
Organization Juntendo University School of Medicine
Division name Neurology
Zip code
Address Bunkyo-ku Hongo 3-1-1, Tokyo, Japan
TEL +813-3813-3111
Homepage URL
Email

Sponsor
Institute Department of Neurology, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Department of Neurology, Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂大学医学附属順天堂医院 (東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The total UPDRS score of the H2-water group (n = 9) improved-1.0 (median), -5.7+- 8.4 (mean +- SD)], whereas that of the placebo group (n = 8) worsened [4.5, 4.1 +- 9.2]. Despite the minimal number of subjects and the short duration of the trial, the difference was significant (P < 0.05).
Conclusion: Drinking H2-water was safe and well tolerated and improved PD significantly.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 13 Day
Last modified on
2013 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008832

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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