UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009277 |
|---|---|
| Receipt number | R000010898 |
| Scientific Title | Relation between the stress and bronchial asthma |
| Date of disclosure of the study information | 2012/11/20 |
| Last modified on | 2022/11/15 13:57:50 |
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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
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
ykatura@junetndo.ac.jp
Sponsor or person
Institute
Juntendo University, Faculty of Medicine
Department of Respiratory medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 20 | Day |
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
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.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 |
