UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055638 |
|---|---|
| Receipt number | R000063585 |
| Scientific Title | Effects of elements on diseases of the airways and sensory organs |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2025/09/29 08:58:37 |
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Basic information
Public title
Effects of elements on diseases of the airways and sensory organs
Acronym
Evaluation of elements
Scientific Title
Effects of elements on diseases of the airways and sensory organs
Scientific Title:Acronym
Evaluation of elements
Region
| Japan |
Condition
Condition
Allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of heavy metals on allergic rhinitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the association between heavy metals and allergic rhinitis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects and allergic rhinitis patients
Key exclusion criteria
In the case of subjects even above 20 years old, subjects who do not have judgement and consciousness and who need to be considered for diseases are also excluded. In addition, subjects who are not applicable to medical instruments used in this study are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Occupational and Environmental Health
Zip code
466-0065
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2124
kato.masashi.r6@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Kato |
Organization
Nagoya University Graduate School of Medicine
Division name
Occupational and Environmental Health
Zip code
466-0065
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2124
Homepage URL
kato.masashi.r6@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2479
Iga-shinsa@adm.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are continuing to recruit subjects through posters and other means.
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063585
