UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041810 |
|---|---|
| Receipt number | R000047010 |
| Scientific Title | The effects of smoking traditional tobacco and novel tobacco on endothelial function |
| Date of disclosure of the study information | 2020/09/16 |
| Last modified on | 2021/09/16 11:26:27 |
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Basic information
Public title
The effects of smoking traditional tobacco and novel tobacco vapor on vascular function
Acronym
Traditional tobacco, novel tobacco vapor and vascular function
Scientific Title
The effects of smoking traditional tobacco and novel tobacco on endothelial function
Scientific Title:Acronym
Traditional tobacco, novel tobacco vapor and endothelial function
Region
| Japan |
Condition
Condition
Smokers (more or equal 10 traditional tobacco per day), age 20-79.
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of smoking traditional tobacco and novel tobacco vapor on endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelial function(FMD)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Traditional tobacco
Interventions/Control_2
Nobel tobacco vapor
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Smokers (more or equal 10 traditional tobacco), age20-79.
Key exclusion criteria
Subjects who can not quit smoking for one day.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Higashi |
| Middle name | |
| Last name | Yukihito |
Organization
Hiroshima University Hospital
Division name
Division of Regeneration and medicine
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
+81822575831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Higashi |
| Middle name | |
| Last name | Yukihito |
Organization
Hiroshima University Hospital
Division name
Cardiology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
+81822575831
Homepage URL
ts5216yt@gmail.com
Sponsor or person
Institute
Division of Regeneration and medicine
Institute
Department
Personal name
Funding Source
Organization
contributions
Smoking Research Fundation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University hospital IRB
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5596
hugcp@hiroshima-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
| 2020 | Year | 09 | Month | 16 | 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
| 2020 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047010
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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