UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019082
Receipt number R000021483
Scientific Title the effect of smell dysfunction using hydrogen gas for parkinson disease
Date of disclosure of the study information 2015/09/22
Last modified on 2018/03/23 09:40:05

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Basic information

Public title

the effect of smell dysfunction using hydrogen gas for parkinson disease

Acronym

the effect of smell dysfunction using hydrogen gas for parkinson disease

Scientific Title

the effect of smell dysfunction using hydrogen gas for parkinson disease

Scientific Title:Acronym

the effect of smell dysfunction using hydrogen gas for parkinson disease

Region

Japan


Condition

Condition

parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the effect of hydrogen gas for smell dysfunction in parkinson's disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint with efficacy in PD was the change of smell test(OSIT-J) and urin 8-8OHdG from baseline to the one month.smell test and Urinary 8-OHdG were measured before treatment and after one month of intervention trial. then two months of discontinuation of the intervention was done. smell test and Urinary 8-OHdG were measured before treatment and after one month of intervention trial.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after room air.

Interventions/Control_2

we measured smell test and urine 8-OHdG before and after room air. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

parkinson's disease
no limitation ofsex, age

Key exclusion criteria

The patients who could not use the tools.
The patients who did not obtain consent.
The patients who have vascular disease, DM, nose disordes.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaki Hirayama

Organization

Nagoya University Graduate School of Medicine

Division name

department of clinical laboratory

Zip code


Address

Daiko-Minami, Higashi-ku, Nagoya City, Aichi Prefecture

TEL

0527191184

Email

hirasan@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaaki Hirayama

Organization

Nagoya University Graduate School of Medicine

Division name

department of clinical laboratory

Zip code


Address

Daiko-Minami, Higashi-ku, Nagoya City, Aichi Prefecture

TEL

0527191184

Homepage URL


Email

hirasan@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nagoya University Graduate 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



Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 22 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

there are no effect to improve smell function in Parkinson's disease patients.
The level of urine 8-OHdG slightly increase using hydrogen gas.

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

2015 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 10 Day

Last follow-up date

2017 Year 10 Month 10 Day

Date of closure to data entry

2018 Year 03 Month 01 Day

Date trial data considered complete

2018 Year 03 Month 01 Day

Date analysis concluded

2018 Year 03 Month 21 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 20 Day

Last modified on

2018 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021483


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name