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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010014
Receipt No. R000010386
Official scientific title of the study Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease
Date of disclosure of the study information 2013/02/13
Last modified on 2017/05/02

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Basic information
Official scientific title of the study Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease
Title of the study (Brief title) Randomized Double-blind, Placebo-controlled trial on hydrogen water in Parkinson Disease
Region
Japan

Condition
Condition Parkinson's disesase
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We tested whether H2-water can modify the progression of PD from the baseline to the 72th week visit as the primary end point.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

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

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 hydrogen water made by "Suisosui5.0"
Interventions/Control_2 placebo-water (nitrogen filling water)
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 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.
Key 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.
Target sample size 200

Research contact person
Name of lead principal investigator Asako Yoritaka
Organization Juntendo University Koshigaya Hospital
Division name Neurology
Address Koshigaya-shi Fukuroyama 560, Saitama, Japan
TEL -81-48-975-0321
Email ayori@juntendo.ac.jp

Public contact
Name of contact person Shimo Y, Hatano T, Ohyama G, Ando M, Yoritaka A.
Organization Juntendo University School of Medicine
Division name Neurology
Address Hongo3-1-3, Bunky-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email ayori@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine, Neurology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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 順天堂大学医学部附属順天堂医院(東京都) 脳神経内科 外来
順天堂大学医学部附属静岡病院(静岡県) 脳神経内科 外来
順天堂大学医学部附属浦安病院(千葉県) 脳神経内科 外来
順天堂大学医学部附属練馬病院(東京都) 脳神経内科 外来
順天堂大学医学部附属江東高齢者医療センター(東京都) 脳神経内科 外来
順天堂大学医学部附属越谷病院(埼玉県) 神経内科 外来
岩手医科大学附属病院(岩手県) 神経内科 外来
青森県立中央病院(青森県) 脳神経センター 外来
秋田県立脳血管研究センター(秋田県) 神経内科 外来
名古屋大学(愛知県) 神経内科 外来
洛和会みささぎ病院(京都府) 神経内科 外来
広島大学(広島県) 神経内科 外来
福岡大学(福岡県) 神経内科 外来
東京臨海病院(東京都) 神経内科 外来
北野病院(大阪府) 神経内科外来
あべ神経内科クリニック(岩手県) 神経内科外来

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 13 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 01 Day
Anticipated trial start date
2013 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 02 Month 12 Day
Last modified on
2017 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010386

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/08/16 BMC Neurology 2016 H2multicenter protocol.pdf


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