UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	the effect of smell dysfunction using hydrogen gas for parkinson disease
Title of the study (Brief title)	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	Masaki Hirayama
Organization	Nagoya University Graduate School of Medicine
Division name	department of clinical laboratory
Address	Daiko-Minami, Higashi-ku, Nagoya City, Aichi Prefecture
TEL	0527191184
Email	hirasan@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masaaki Hirayama
Organization	Nagoya University Graduate School of Medicine
Division name	department of clinical laboratory
Address	Daiko-Minami, Higashi-ku, Nagoya City, Aichi Prefecture
TEL	0527191184
Homepage URL
Email	hirasan@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021483