UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007497
Receipt number 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 23:09:51

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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 or person

Institute

Department of Neurology, Juntendo University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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