UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036501
Receipt number R000041486
Scientific Title Examination of the influence of blood BDNF changes by contrast bath in healthy people
Date of disclosure of the study information 2019/05/01
Last modified on 2020/10/13 09:29:07

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Basic information

Public title

Examination of the influence of blood BDNF changes by contrast bath in healthy people

Acronym

Examination of the influence of blood BDNF changes by contrast bath in healthy people

Scientific Title

Examination of the influence of blood BDNF changes by contrast bath in healthy people

Scientific Title:Acronym

Examination of the influence of blood BDNF changes by contrast bath in healthy people

Region

Japan


Condition

Condition

healthy people

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the influence of contrast bath on blood BDNF changes in healthy adult men.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concentration of Blood BDNF

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

contrast bath

Interventions/Control_2

bathing in 30 degree

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

65 years-old >=

Gender

Male

Key inclusion criteria

1 Men aged 20 to 65
2 People who want to participate by oneself

Key exclusion criteria

People who has a history of cardiovascular, lung, liver, kidney disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Fumihiro
Middle name
Last name Tajima

Organization

Wakayama medical university

Division name

Department of rehabilitaion medicine

Zip code

641-8509

Address

811-1 Kimiidera,Wakayama City,Wakayama Prefecture

TEL

073-441-0664

Email

fumi@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Kota
Middle name
Last name Murai

Organization

Wakayama medical university

Division name

Department of rehabilitaion medicine

Zip code

641-8509

Address

811-1 Kimiidera,Wakayama City,Wakayama Prefecture

TEL

073-441-0664

Homepage URL


Email

med811km@gmail.com


Sponsor or person

Institute

Wakayama medical university Department of rehabilitaion medicine

Institute

Department

Personal name



Funding Source

Organization

Wakayama medical university Department of rehabilitaion medicine

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

Wakayama Prefectural University of Medicine Ethics Review Committee

Address

811-1 Kimiidera,Wakayama City,Wakayama Prefecture

Tel

073-441-0897

Email

wa-rinri@wakayama-med.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

2019 Year 05 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

10

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 04 Month 04 Day

Date of IRB

2019 Year 04 Month 24 Day

Anticipated trial start date

2019 Year 05 Month 01 Day

Last follow-up date

2024 Year 04 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 04 Month 13 Day

Last modified on

2020 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041486


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name