UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049675 |
|---|---|
| Receipt number | R000056579 |
| Scientific Title | Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking. |
| Date of disclosure of the study information | 2022/12/03 |
| Last modified on | 2023/08/02 18:16:43 |
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Basic information
Public title
Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking.
Acronym
Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking.
Scientific Title
Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking.
Scientific Title:Acronym
Investigation of effectiveness of inhalation intake of beta-caryophyllene (BCP) against vascular wall stiffening caused by smoking.
Region
| Japan |
Condition
Condition
Smoker
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether smoking and inhalation of beta-caryophyllene (BCP) affect brachio-ankle pulse wave velocity (baPWV). In addition, it will be verified whether it affects vital capacity and the ratio of FEV1 to forced vital capacity (1-second rate), and whether blood markers (hsCRP, fibrinogen) decrease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate in brachial-ankle pulse wave velocity (baPWV) (week 12)
Key secondary outcomes
Respiratory function test
1) Amount of change in vital capacity (4,8,12weeks)
2) Change rate in percent vital capacity Amount of change in vital capacity (4,8,12weeks)
3) Amount of change in one second rete (4,8,12weeks).
4) 1 second rate of change (4,8,12weeks).
5) Amount of change in hsCRP (4,8,12weeks).
6) Change rate in hsCRP (4,8,12weeks).
7) Amount of change in fibrinogen (4,8,12weeks).
8) Change rate in fibrinogen (4,8,12weeks).
9) Changes in original questionnaire survey (4,8,12weeks).
10)Changes in SF-36 (4,8,12weeks).
11)Amount of change in brachial-ankle pulse wave velocity (baPWV) (4, 8weeks).
12) Change rate in brachial-ankle pulse wave velocity (baPWV) (4,8,12weeks).
* baPWV: Evaluate the left-right average value.
<Other outocome>
Ankle Brachial Index (ABI)
1)Amount of change in Ankle Brachial Index (4,8,12weeks).
2) Change rate in Ankle Brachial Index (4,8,12weeks).
*ABI: Evaluate the value measured for each of the left and right sides.
Left ABI = (Left leg lower systolic pressure) / (high upper arm systolic pressure (or right side)
Right ABI = (Right leg systolic pressure)/(high upper arm right systolic pressure (left or right)
Blood pressure
3) Amount of change in blood pressure (4,8,12weeks).
4) Rate of change in blood pressure (4,8,12weeks).
*For blood pressure, evaluate the value of the arm with the higher systolic blood pressure among the upper arms.
Hert rate
7) Amount of change in Heart rate (4,8,12weeks).
8) Change rate in Heart rate (4,8,12weeks).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
According to the randomaization results, a capsule containing 19.30 mg of MCT will be attached to the filter portion of the tobacco that is usually smoked, and the capsule will be destroyed immediately before smoking. The amount smoked is at the discretion of the subjects.
Interventions/Control_2
According to the randomaization results, a capsule containing 2.9 mg of BCP and 16.4 mg of MCT will be attached to the filter portion of the tobacco that is usually smoked, and the capsule will be destroyed immediately before smoking. The amount smoked is at the discretion of the subjects.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The person who has ability to consent.
2) Healthy adult smokers.
3) The person who has a smoking history of 5 pack-years or more.
4) The person who would be 59 years old or less at the time of obtein informed consent.
5) The person who regularly smoke one of the brands of the 80 brands listed.
6) The person whose baPWV is 1300 cm/s or more and less than 1800 cm/s.
7) The person whose ABI is between 1.0 and 1.4.
8) The person whose FEV1% is 70% or more and % vital capacity is 80% or more.
9) The person whose blood and urine tests are within the normal range (not within the range of organ damage).
10) The person whose has presence of cotinine in saliva.
11) The person who has obtained written consent from the person to participate in this study.
Key exclusion criteria
1) Smokers who smoke tobacco other than tabaccos (pipes, etc.)
2) The person whose a resting systolic blood pressure of 140 mmHg or higher or a diastolic blood pressure of 90 mmHg or higher.
3) The person whose plaque on carotid artery ultrasound.
4) The person whose abnormal chest X-ray images.
5) The person whose observations on electrocardiography that judged inappropriate for participation in this the study by the principal investigator or co-investigator.
6) The person who is taking medicines or undergoing medical treatment.
7) The person who are pregnant/lactating or wish to become pregnant during the study period.
8) The person who take health foods (excluding products with only vitamins and minerals as active ingredients) on a daily basis.
9) The person who intend to quit smoking.
10) The person judged inappropriate for participation in this the study by the principal investigator or co-investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Mochizuki |
Organization
Medical Corporation Emilio Moriguchi
Shibaura Three One Clinic
Division name
Internal Medicine / Surgery
Zip code
105-0023
Address
1-3-10, Shibaura, Minato-ku, Tokyo, japan 105-0023
TEL
03-6779-8181
yomochizuki@nifty.com
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Mishima |
Organization
CMIC HealthCare Institute Co., Ltd
Division name
Clinical Trial Solution Dept.
Zip code
105-0023
Address
HaHamamatsucho Bldg., 1-1-1 Shibaura Minato-ku, Tokyo, 105-0023
TEL
03-6779-8160
Homepage URL
yoshiyuki-mishima@cmicgroup.com
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
Hillside Clinic Jingumae Ethics Committe
Address
4-22-11 Jingumae, Shibuya-ku, Tokyo
Tel
03-6779-8166
naoki-kitazawa@cmicgroup.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
医療法人社団エミリオ森口 芝浦スリーワンクリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 03 | 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
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | 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 | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056579
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