Smoker
Conditions
Interventions
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 immediatel
Sponsors
Sunsho Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate in brachial-ankle pulse wave velocity (baPWV) (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Mishima
CMIC HealthCare Institute Co., Ltd Clinical Trial Solution Dept.
Outcome results
None listed