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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009277
Receipt No. R000010898
Scientific Title Relation between the stress and bronchial asthma
Date of disclosure of the study information 2012/11/20
Last modified on 2014/10/30

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Basic information
Public title Relation between the stress and bronchial asthma
Acronym Relation between the stress and bronchial asthma
Scientific Title Relation between the stress and bronchial asthma
Scientific Title:Acronym Relation between the stress and bronchial asthma
Region
Japan

Condition
Condition Bronchial Asthma
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the influence of psychological stress on the condition of Bronchial asthma.
Basic objectives2 Others
Basic objectives -Others global analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Concentration of Salivary cortisol
Concentration of Salivary chromogranin A
Concentration of Serum IL4
Concentration of Serum IL5
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who has a primary diagnosis of asthma.
Key exclusion criteria Patients who has a past diagnosis of other respiratory disease or psychological disease.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Atsuta
Organization Juntendo University School of Medicine
Division name Department of Respiratory medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo
TEL 03-5802-1063
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Katsura
Organization Juntendo University School of Medicine
Division name Department of Respiratory medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo
TEL 03-5802-1063
Homepage URL
Email ykatura@junetndo.ac.jp

Sponsor
Institute Juntendo University, Faculty of Medicine
Department of Respiratory medicine
Institute
Department

Funding Source
Organization Juntendo University, Faculty of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 20 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
The total number of subject with asthma was 61 (22 males,39 females),and 14 were classified as psychophysiologic disorder and 26 as possibility of psychophysiologic disorder. The group of  psychophysiologic disorder was tend to have high step treatment.  The concentration of salivary cortisol was significantly low in the group of high step treatment. The concentration of chromogranin A was significantly high in the group of  psychophysiologic disorder .
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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 20 Day
Last follow-up date
2014 Year 10 Month 31 Day
Date of closure to data entry
2014 Year 10 Month 31 Day
Date trial data considered complete
2014 Year 10 Month 31 Day
Date analysis concluded
2014 Year 10 Month 31 Day

Other
Other related information This study is a prospective study to examine the influence of psychological stress on the condition of Bronchial asthma.
Questionnaire would be performed and saliva and blood would be sampled.

Management information
Registered date
2012 Year 11 Month 07 Day
Last modified on
2014 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010898

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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