UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048510 |
|---|---|
| Receipt number | R000055234 |
| Scientific Title | Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2022/07/27 11:11:32 |
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Basic information
Public title
Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV
Acronym
Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV
Scientific Title
Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV
Scientific Title:Acronym
Randomized controlled trials to verify that inhalation of beta-caryophyllene improves vascular wall hardening and lowers baPWV
Region
| Japan |
Condition
Condition
smokers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether inhalation and ingestion of beta-caryophyllene concurrently with smoking suppresses the increase in brachial-ankle pulse wave velocity (baPWV).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in Brachial-ankle Pulse Wave Velocity 12 weeks after the start of study
Key secondary outcomes
Improving the experience
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Cigarettes filled with capsules of the following contents were supplied to the filter part of cigarettes that normally smoke. The capsules were destroyed immediately before smoking and then smoked at discretion.
beta-caryophyllene 5.79 mg, MCT 13.51 mg
Interventions/Control_2
Cigarettes filled with capsules of the following contents were supplied to the filter part of cigarettes that normally smoke. The capsules were destroyed immediately before smoking and then smoked at discretion.
beta-caryophyllene 2.90 mg, MCT 16.40 mg
Interventions/Control_3
Cigarettes filled with capsules of the following contents were supplied to the filter part of cigarettes that normally smoke. The capsules were destroyed immediately before smoking and then smoked at discretion.
MCT 19.30 mg (Placebo)
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 adult men and women smokers who smoke regular cigarettes
Key exclusion criteria
Non-smokers, smokers who smoke cigarettes other than cigarettes (pipes, etc.), smokers who smoke non-regular type (slim type) cigarettes, those who plan to quit during the period, are being treated for illness or those who need or plan to treat their illness, those who wish to become pregnant during the period, those who are pregnant / lactating, those who take medicine, those who take health foods (excluding products of active ingredients are only vitamins and minerals) on a daily basis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Matahira |
Organization
Sunsho Pharmaceutical Co.,Ltd.
Division name
Innovation Center
Zip code
418-0013
Address
533-2, Oiwa, Fujinomiya Shi, Shizuoka Ken, 418-0013, Japan
TEL
0544-25-7799
y.matahira@sunsho.co.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Yamada |
Organization
Sunsho Pharmaceutical Co.,Ltd.
Division name
Innovation Center
Zip code
419-0201
Address
1468, Atsuhara, Fuji Shi, Shizuoka Ken, 419-0201, Japan
TEL
0545-73-0610
Homepage URL
kazuya.yamada@sunsho.co.jp
Sponsor or person
Institute
Sunsho Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sunsho Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sansho Pharmaceutical Co., Ltd. Ethics Review Board
Address
1468, Atsuhara, Fuji Shi, Shizuoka Ken, 419-0201, Japan
Tel
0545-73-0610
masaki.ookawara@sunsho.co.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
| 2022 | Year | 08 | Month | 15 | 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
19
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
| 2021 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055234
