Trial of Treatment Protocol for Smoking Cessation

NCT ID: NCT02768025

Last Updated: 2018-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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.)

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Traditional & Complementary Medicine treatment

Intervention Type OTHER

Body acupuncture, Ear acupuncture and aromatic therapy

NRT, counselling

Intervention Type OTHER

Nicotine Replacement Therapy, counselling

Control group

NRT, counselling

Group Type ACTIVE_COMPARATOR

NRT, counselling

Intervention Type OTHER

Nicotine Replacement Therapy, counselling

Interventions

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Traditional & Complementary Medicine treatment

Body acupuncture, Ear acupuncture and aromatic therapy

Intervention Type OTHER

NRT, counselling

Nicotine Replacement Therapy, counselling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 1\) suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daejeon University

OTHER

Sponsor Role lead

Responsible Party

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Sunju Park

Medical Doctor, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Choong sik Cho, Doctor

Role: PRINCIPAL_INVESTIGATOR

Daejeon University

Locations

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Dunsan Korean Medicine Hospital of Daejeon University

Daejeon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28576892 (View on PubMed)

Other Identifiers

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SCKM_01

Identifier Type: -

Identifier Source: org_study_id

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