UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037169
Receipt number R000042353
Scientific Title Change of hydrogen concentration in breath by H2 supplementation
Date of disclosure of the study information 2019/06/25
Last modified on 2019/07/17 11:08:54

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Basic information

Public title

Change of hydrogen concentration in breath by H2 supplementation

Acronym

Change of hydrogen concentration in breath by H2 supplementation

Scientific Title

Change of hydrogen concentration in breath by H2 supplementation

Scientific Title:Acronym

Change of hydrogen concentration in breath by H2 supplementation

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate hydrogen concentration in breath by H2 supplementation

Basic objectives2

Others

Basic objectives -Others

To investigate change of hydrogen concentration in breath by H2 supplementation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hydrogen concentration in breath

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

dietary supplementation of super H2

Interventions/Control_2

Drinking water

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

20 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy

Key exclusion criteria

people who have any diseases under-treatment

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Motoko
Middle name
Last name Kawashima

Organization

Kuki Kawashima Eye Clinic

Division name

Ophthalmology

Zip code

3400212

Address

Kuhonji 303-1, Kuki city, Saitama

TEL

0480538306

Email

motoko326@gmail.com


Public contact

Name of contact person

1st name Motoko
Middle name
Last name Kawashima

Organization

Haneginomori Eye Clinic

Division name

Opthalmology

Zip code

1550033

Address

4 Chome-26-4 Daita, Setagaya City, Tokyo

TEL

03-6265-8777

Homepage URL


Email

motoko326@gmail.com


Sponsor or person

Institute

Haneginomori Eye Clinic

Institute

Department

Personal name



Funding Source

Organization

Tsubota laboratory Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Institutional Review Board of Haneginomori Eye Clinic

Address

4 Chome-26-4 Daita, Setagaya City, Tokyo

Tel

03-6265-8777

Email

mail@hanegi-eye.com


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 06 Month 25 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

2019 Year 06 Month 14 Day

Date of IRB

2019 Year 06 Month 14 Day

Anticipated trial start date

2019 Year 06 Month 15 Day

Last follow-up date

2019 Year 06 Month 30 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 06 Month 25 Day

Last modified on

2019 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name