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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000019082
Date of registration:	22/09/2015
Prospective Registration:	Yes
Primary sponsor:	Nagoya University Graduate School of Medicine
Public title:	the effect of smell dysfunction using hydrogen gas for parkinson disease
Scientific title:	the effect of smell dysfunction using hydrogen gas for parkinson disease - the effect of smell dysfunction using hydrogen gas for parkinson disease
Date of first enrolment:	2015/10/10
Target sample size:	20
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021483
Study type:	Interventional
Study design:	Cross-over Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Masaki Hirayama
Address:	Daiko-Minami, Higashi-ku, Nagoya City, Aichi Prefecture Japan
Telephone:	0527191184
Email:	hirasan@med.nagoya-u.ac.jp
Affiliation:	Nagoya University Graduate School of Medicine department of clinical laboratory

Name:	Masaaki Hirayama
Address:	Daiko-Minami, Higashi-ku, Nagoya City, Aichi Prefecture Japan
Telephone:	0527191184
Email:	hirasan@med.nagoya-u.ac.jp
Affiliation:	Nagoya University Graduate School of Medicine department of clinical laboratory

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

parkinson's disease

Intervention(s)

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.
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.

Primary Outcome(s)

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.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Nagoya University Graduate School of Medicine

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	10/10/2017
URL:

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