CClinicalTrials.gg
CompletedNCT02768025Updated Feb 1, 2018

Trial of Treatment Protocol for Smoking Cessation

An interventional study of Traditional & Complementary Medicine treatment and NRT, counselling in Smoking Cessation, sponsored by Daejeon University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Daejeon University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased.

According the trend, development and evaluation of the medical guideline, Induced participation of medical personnel and available in Korean medical clinic, is needed. Purpose: To evaluate the satisfaction and effect of traditional \& complementary medicine (T\&CM) tobacco control program Methods: Recruited subjects were divided into control and test groups. They treated two times a week during the first three weeks and once a week during the last week.

Program participation rates and drop rates, satisfaction, amount of smoking before and after programs

, smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D) are measured.

Read the detailed description

Subjects in control group are treated NRT and counselling. Nicotine Replacement Therapy is provided 7 patches and 30 gums once a week for 4 weeks. Using amounts are depend on each subject's cravings. (Investigator will check how much they used.) Doctor consults about 10-15 minutes per visit.

Subjects in intervention group are treated NRT, counselling and traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Body acupoints are HT7, LI4, ST36, LU7, LU6 on both sides. Ear acupoints are Shenmen, Lung, Pharynx, Trachea, Endocrine. Subjects are treated with acupuncture for 20 minutes per visit and put ear acupuncture like sticker for 1-2 days. Mixture oil of Lavender, peppermint, rosemary are used to massage behind the ears. It is used 2 times a day and they can adjust frequency depending on their cravings.(Investigator will check how much they used.)

02

Conditions studied

  • Smoking Cessation

Keywords

  • smoking cessation
  • tobacco control
  • acupuncture
  • Korean Medicine
  • Traditional & Complementary Medicine
03

In context

Lead sponsor

Daejeon University is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. having willing to stop smoking 2) currently smoking and applying one of the following

Exclusion criteria

Exclusion Criteria:

    1. suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Intervention group

    NRT, counselling, traditional \& complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy).

    Other: Traditional & Complementary Medicine treatment · Other: NRT, counselling

  • Active comparator
    Control group

    NRT, counselling

    Other: NRT, counselling

Interventions

  • OtherTraditional & Complementary Medicine treatment

    Body acupuncture, Ear acupuncture and aromatic therapy

  • OtherNRT, counselling

    Nicotine Replacement Therapy, counselling

06

What researchers measure

Primary outcomes

  1. Continuous Abstinence Rate

    endpoint of treatment

    Time frame: 4 week

Secondary outcomes

  1. 7-day Point Prevalence Abstinence

    follow-up measure

    Time frame: 6,8,12,16,24 week

  2. Prolonged Abstinence Rate

    follow-up measure

    Time frame: 3,6 month

  3. Program participation rate

    each treatment and follow-up

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  4. Amount of smoking

    each treatment and follow-up

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  5. Tobacco craving

    each treatment and follow-up

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  6. Exhaled Carbon monoxide monoxide

    each treatment and follow-up

    Time frame: 0,7,10,14,17 day, 3,4,6,8,12,16,24 week

  7. Quality of life

    beginning and endpoint of treatment

    Time frame: 0,4 week

  8. Nicotine dependence test (Fagerstrom test)

    Time frame: 10, 17 day, 4week

  9. Withdrawal symptoms

    Time frame: 1,2,3,4 week

07

Study locations

1 site
  • Dunsan Korean Medicine Hospital of Daejeon University
    Daejeon, 35235, Korea, Republic of
08

References and documents

Publications

  • Jang S, Park S, Jang BH, Park YL, Lee JA, Cho CS, Go HY, Shin YC, Ko SG. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy. BMJ Open. 2017 Jun 2;7(5):e014574. doi: 10.1136/bmjopen-2016-014574. PubMed 28576892 ↗

Individual participant data

Plan to share: No — This is confidential.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02768025
Lead sponsor
Daejeon University
Responsible party
Sunju Park (Medical Doctor, Professor, Daejeon University) — Principal investigator
First posted
May 11, 2016
Start date
Jul 1, 2016
Primary completion
Jul 1, 2017
Completion
Aug 31, 2017
Last update
Feb 1, 2018

Study contacts

Choong sik Cho, Doctor
principal investigator · Daejeon University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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