UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020424 |
|---|---|
| Receipt number | R000019677 |
| Scientific Title | A pilot study for the association between home environment and allergic symptom |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2021/07/09 14:28:45 |
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Basic information
Public title
A pilot study for the association between home environment and allergic symptom
Acronym
home environment and allergic symptom
Scientific Title
A pilot study for the association between home environment and allergic symptom
Scientific Title:Acronym
home environment and allergic symptom
Region
| Japan |
Condition
Condition
asthma, asthmatic bronchitis, allergic rhinitis, allergic conjunctivitis, pollinosis
Classification by specialty
| Clinical immunology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the risk of count concentration of particulate matter to allergic symptom exacerbation
Basic objectives2
Others
Basic objectives -Others
To present basic data for the evaluation of efficacy of the environmental maintenance advice by the professional of the cleaning
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Allergy Control Score during the study (Time-series analysis)
Key secondary outcomes
Pollen counts in house dust
Count concentration of particulate matter
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Advise of environment maintainance by professional cleaners
Interventions/Control_2
Advise nothing
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Live in Kyoto city (within about 20km from Kyoto University School of Public Health) or in Kizu city
Mother of 1~15 years old children who has at least one of the followings
asthma, asthmatic bronchitis, allergic rhinitis, allergic conjunctivitis, pollinosis
Key exclusion criteria
Spend less than 12 hours at home (allergic child)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Nakayama |
Organization
Kyoto University School of Public Health
Division name
Health Informatics
Zip code
660-0000
Address
Yoshida Konoe-cho, Sakyo, Kyoto
TEL
075-753-4488
nakayama.takeo.4a@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | Tsuji |
| Last name | Kanatani |
Organization
Kyoto University School of Public Health
Division name
Health Informatics
Zip code
660-0000
Address
Yoshida Konoe-cho, Sakyo, Kyoto
TEL
080-6186-9375
Homepage URL
kosa-office@umin.ac.jp
Sponsor or person
Institute
Kyoto University School of Public Health
Departement of Health Informatics
Institute
Department
Personal name
Funding Source
Organization
Duskin
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Duskin
Name of secondary funder(s)
Self-funding
IRB Contact (For public release)
Organization
Kyoto University Graduate School
Address
Shogoin-Kawahara-cho 53, Sakyo, Kyoto
Tel
075-751-4182
kanatani.kumiko.2r@kyoto-u.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
京都大学大学院医学研究科 健康情報学（京都府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 12 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 13 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 04 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019677
