UMIN-CTR Clinical Trial

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
Email	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
Email	kazuya.yamada@sunsho.co.jp

Sponsor
Institute	Sunsho Pharmaceutical Co.,Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055234