UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039796
Receipt number R000044634
Scientific Title Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Date of disclosure of the study information 2020/03/31
Last modified on 2022/03/14 14:14:13

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Basic information

Public title

Evaluation of the effect of olfactory training on cognitive function in healthy adults.

Acronym

Evaluation of the effect of olfactory training on cognitive function in healthy adults.

Scientific Title

Evaluation of the effect of olfactory training on cognitive function in healthy adults.

Scientific Title:Acronym

Evaluation of the effect of olfactory training on cognitive function in healthy adults.

Region

Japan


Condition

Condition

Cognitive dysfunction

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of olfactory training with aromatherapy on memory function in healthy elderly subjects

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

memory function ( a 24-week period)

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

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

essential oil (rose odor, eucalyptus odor, lemon odor, and cloves odor)

Interventions/Control_2

essential oil (rosemary odor, lavender odor, lemon odor, and orange odor)

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

60 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

60 years or older

Key exclusion criteria

subjects who were diagnosed with dementia and receiving treatment

Target sample size

24


Research contact person

Name of lead principal investigator

1st name SACHIKO
Middle name TANAKA
Last name TANAKA

Organization

Tokyo University of Pharmacy and Life Sciences

Division name

Department of Clinical Pharmacology

Zip code

192-0392

Address

1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan

TEL

0426765796

Email

sachiko@toyaku.ac.jp


Public contact

Name of contact person

1st name SACHIKO
Middle name TANAKA
Last name TANAKA

Organization

Tokyo University of Pharmacy and Life Sciences

Division name

Department of Clinical Pharmacology

Zip code

192-0392

Address

1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan

TEL

0426765796

Homepage URL


Email

sachiko@toyaku.ac.jp


Sponsor or person

Institute

Tokyo University of Pharmacy and Life Sciences

Institute

Department

Personal name



Funding Source

Organization

Tokyo University of Pharmacy and Life Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo University of Pharmacy and Life Sciences

Address

1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan

Tel

0426765111

Email

sakurai@toyaku.ac.jp


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

2020 Year 03 Month 31 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

Preinitiation

Date of protocol fixation

2020 Year 03 Month 31 Day

Date of IRB

2020 Year 01 Month 30 Day

Anticipated trial start date

2022 Year 10 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 12 Day

Last modified on

2022 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044634


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name