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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036291
Receipt No. R000041343
Scientific Title Effect of auricle therapy on learning context,sleep and depression
Date of disclosure of the study information 2020/04/01
Last modified on 2021/03/26

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Basic information
Public title Effect of auricle therapy on learning context,sleep and depression
Acronym Effect of auricle therapy on learning context.
Scientific Title Effect of auricle therapy on learning context,sleep and depression
Scientific Title:Acronym Effect of auricle therapy on learning context.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study aimed to investigate whether learning context could change by auricle therapy in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes learning context
Key secondary outcomes sleep quality
depression

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 control: sham acupuncture(28days)
Interventions/Control_2 real acupuncture(28days)
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
16 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria 1. Aged 20-29 years.
2. Person that informed consent was provided.
Key exclusion criteria 1. Person having a disease.
2. Person who takes medicine.
3. Current smokers
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Waki
Organization University of Teikyoheise Faculty of Health Care
Division name Department of acupuncture and Moxibustion.
Zip code 170-8445
Address 2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL 035-843-3111
Email h.waki@thu.ac.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Waki
Organization University of Teikyoheise Faculty of Health Care
Division name Department of acupuncture and Moxibustion.
Zip code 170-8445
Address 2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL 03-5843-3111
Homepage URL
Email h.waki@thu.ac.jp

Sponsor
Institute Teikyo Heisei University
Institute
Department

Funding Source
Organization Teikyo Heisei University
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 Teikyo Heisei University
Address Higashiikebukuro, Toshima-ku, Tokyo
Tel 03-5843-3111
Email rec@thu.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 04 Month 01 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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 11 Day
Date of IRB
2019 Year 06 Month 01 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 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 03 Month 25 Day
Last modified on
2021 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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