UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036344
Receipt number R000041409
Scientific Title Evaluation of effects of volatile materials on biological functions
Date of disclosure of the study information 2019/04/15
Last modified on 2019/09/04 17:01:15

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Basic information

Public title

Evaluation of effects of volatile materials on biological functions

Acronym

Evaluation of effects of volatile materials on biological functions

Scientific Title

Evaluation of effects of volatile materials on biological functions

Scientific Title:Acronym

Evaluation of effects of volatile materials on biological functions

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of volatile materials on immune function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Indicators of immune function; ex)activity of immune cells, mucociliary activity

Key secondary outcomes

Nasal airway resistance value


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

6

Purpose of intervention

Prevention

Type of intervention

Device,equipment Other

Interventions/Control_1

exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)

Interventions/Control_2

exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)

Interventions/Control_3

exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)

Interventions/Control_4

exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material C (10 minutes)->wash out (3 days)

Interventions/Control_5

exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)

Interventions/Control_6

exposure to volatile material C (10 minutes)->wash out (3 days)->exposure to volatile material B (10 minutes)->wash out (3 days)->exposure to volatile material A (10 minutes)->wash out (3 days)

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male

Key inclusion criteria

Healthy men

Key exclusion criteria

-Subjects with chronic nasal disease
-Subjects with nasal scratch
-Subjects with severe disease
-Subjects to go to hospital or to take medicines for treatment.
-Subjects to participate in research or treatment with effects on this study
-Subjects with skin trouble by alcohol
-Subjects with claustrophobia
-Smokers
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Takuya
Middle name
Last name Mori

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7440

Email

mori.takuya@kao.com


Public contact

Name of contact person

1st name Ikumi
Middle name
Last name Takada

Organization

Kao Corporation

Division name

Biological Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7440

Homepage URL


Email

takada.ikumi@kao.com


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

Human Research Ethics Committee, Kao Corporation

Address

2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN

Tel

+81-3-5630-9220

Email

uesaka.toshio@kao.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

花王株式会社(栃木県)


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 15 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

25

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 03 Month 22 Day

Date of IRB

2019 Year 03 Month 22 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2019 Year 07 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 09 Month 04 Day


Other

Other related information



Management information

Registered date

2019 Year 03 Month 29 Day

Last modified on

2019 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name