UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025001 |
|---|---|
| Receipt number | R000028767 |
| Scientific Title | Antitussive effect of a chest band in patients with interstitial lung disease: a pre-post intervention study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/06/25 14:27:23 |
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Basic information
Public title
Antitussive effect of a chest band in patients with interstitial lung disease: a pre-post intervention study
Acronym
Antitussive effect of a chest band in patients with interstitial lung disease
Scientific Title
Antitussive effect of a chest band in patients with interstitial lung disease: a pre-post intervention study
Scientific Title:Acronym
Antitussive effect of a chest band in patients with interstitial lung disease
Region
| Japan |
Condition
Condition
Interstitial lung disease
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the antitussive effect of a chest band in patients with interstitial lung disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cough intensity and frequency using a Visual Analog Scale (VAS) ranging from 0 to 100 mm.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
chest band (24-72 h)
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
Patients with interstitial lung disease who report that VAS scores are more than 10 mm.
Key exclusion criteria
Patients who report respiratory infection within one month, or who have postnasal drip, rhinitis, catarrhal symptoms, or asthma.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Ryuhei |
| Middle name | |
| Last name | Sato |
Organization
Kyoto University Graduate School of Human Health Science
Division name
Department of Critical Care Nursing
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3947
sato.ryuhei.2n@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuhei |
| Middle name | |
| Last name | Sato |
Organization
Kyoto University Graduate School of Human Health Science
Division name
Department of Critical Care Nursing
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3947
Homepage URL
sato.ryuhei.2n@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanazawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Unicersity Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3236-1
Org. issuing International ID_1
Kanazawa University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学医学部附属病院（京都府）/Kyoto University Hospital、金沢大学附属病院（石川県）/Kanazawa University Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | 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
13
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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028767
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
