UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035602 |
|---|---|
| Receipt number | 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 | 2020/04/01 14:54:54 |
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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
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
ayori@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Koshigaya Hospital
Institute
Department
Personal name
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
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
Completed
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 | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039217
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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