UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035602
Receipt No. R000039217
Scientific Title Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease
Date of disclosure of the study information 2019/01/21
Last modified on 2019/07/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease
Acronym Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease
Scientific Title Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease
Scientific Title:Acronym Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease
Region
Japan

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

Objectives
Narrative objectives1 The effectiveness of hydrogen gas for the patients with Parkinson's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of MDS-UPDRS from the baseline to 16th week between hydrogen gas and placebo gas
Key secondary outcomes The change of
parts of MDS-UPDRS
PDQ-39
18-OHdG
N1,N8-diacetylspermidine
from the baseline to 16th week between hydrogen gas and placebo gas

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 hydrogen gas16 weeks inhalation
two times of the inhalation for 60 minutes per day
8 weeks obsebation after the inhalation
Interventions/Control_2 placebo gas
16 weeks inhalation
two times of the inhalation for 60 minutes per day
8 weeks obsebation after the inhalation
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria MDS Parkinson's disease criteria
modified Hoehn and Yahr stage 0~3
without dementia
without lung disease
Key exclusion criteria Parkinsonism except Parkinson's disease
modified Hoehn and Yahr stage 4~5
with dementia
with lung disease
with malignant tumor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asako Yoritaka
Organization Juntendo University Koshigaya Hospital
Division name Neurology
Zip code
Address Fukuroyama 560, Koshigaya-shi, Saitama
TEL 0489750321
Email ayori@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Asako Yoritaka
Organization Juntendo University Koshigaya Hospital
Division name Neurology
Zip code
Address Fukuroyama560, Koshigaya-shi, Saitama
TEL 0489750321
Homepage URL
Email ayori@juntendo.ac.jp

Sponsor
Institute Juntendo University Koshigaya Hospital
Institute
Department

Funding Source
Organization MiZ company
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 21 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 12 Day
Date of IRB
2018 Year 11 Month 12 Day
Anticipated trial start date
2019 Year 01 Month 11 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 21 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039217

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.