UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036369 |
|---|---|
| Receipt number | R000041427 |
| Scientific Title | Improvement effect of Colocolo (the adhesive cleaner) in allergic symptom in patients with pollinosis |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/10/01 17:23:35 |
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Basic information
Public title
Improvement effect of Colocolo (the adhesive cleaner) in allergic symptom in patients with pollinosis
Acronym
Improvement effect of Colocolo in pollinosis
Scientific Title
Improvement effect of Colocolo (the adhesive cleaner) in allergic symptom in patients with pollinosis
Scientific Title:Acronym
Improvement effect of Colocolo (the adhesive cleaner) in allergic symptom in patients with pollinosis
Region
| Japan |
Condition
Condition
pollinosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement effect of Colocolo (the adhesive cleaner) in allergic symptom in patients with pollinosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Face Rating Scale in allergic symptom every day
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Every day using Colocolo after going home
Interventions/Control_2
not using Colocolo
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
1. patients with pollinosis
2. having smartphone
Key exclusion criteria
1. steroid
2. have ever used the Colocolo
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Motokazu |
| Middle name | |
| Last name | Kato |
Organization
Kishiwada City Hospital
Division name
Chest Disease Clinical and Research Institute
Zip code
596-8501
Address
1001 Gakuhara-cho, Kishiwada-shi, Osaka-fu, Japan
TEL
072-445-1000
kch@kishiwada-hospital.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kojima |
Organization
Medical and Health Resources Research Institute
Division name
Representative Director
Zip code
***-****
Address
4-38-7, Higashi-Ikebukuro, Tposhima-ku, Tokyo 170-0013, Japan
TEL
03-5904-8534
Homepage URL
research@mhrri.com
Sponsor or person
Institute
Kishiwada City Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical and Health Resources Research Institute
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
Kishiwada City Hospital
Address
1001 Gakuhara-cho, Kishiwada-shi, Osaka-fu, Japan
Tel
072-445-1000
kch@kishiwada-hospital.com
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 | 04 | 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
31
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
| 2019 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041427
