Smoking Cessation, Withdrawal Symptoms
Conditions
Brief summary
This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution.
Interventions
DIETARY_SUPPLEMENTHoney
Participants need to drink honey every day for four weeks.
DIETARY_SUPPLEMENTWater
Participants need to drink water every day for four weeks.
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the cessation clinic patients aged more than 18 * only take Champix for smoking cessation
Exclusion criteria
* diabetes, cancer, renal disease * with wet and hot body constitution * allergic to honey * accepting traditional Chinese medicine intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fagerstrom Test for Nicotine Dependence | Before and after the 4-week trial, 3 and 6 months after the trial | Change from baseline Fagerstrom Test for Nicotine Dependence at 4 weeks, 3 and 6 months after the trial. Fagerstrom Test for Nicotine Dependence is ranged from 0-10. The higher score the higher dependence on Nicotine. |
| Minnesota Nicotine Withdrawal Scale | Before and after the 4-week trial | Change from baseline Minnesota Nicotine Withdrawal Scale at 4 weeks. The Minnesota Nicotine Withdrawal Scale is ranged from 0-84. The higher score indicates more severe withdrawal syndromes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Anxiety Stress Scales-21 | Before and after the 4-week trial | Change from baseline Depression Anxiety Stress Scales-21 at 4 weeks. The Depression Anxiety Stress Scales-21 contains 3 sub-scales, each is scored form 0-28. The higher score indicates the more negative condition. |
| WHOQOL-BREF | Before and after the 4-week trial | Change from baseline WHOQOL-BREF at 4 weeks. WHOQOL-BREF contains 4 domains, each domain will be calculated to a score ranged from 0-100. The score of 100 indicates satisfaction of QOL. |
| Body Constitution Questionnaire | Before and after the 4-week trial | Change from baseline Body Constitution Questionnaire at 4 weeks. The Body Constitution Questionnaire contains 9 sub-scales, each is ranged from 0-100. The higher score indicates the likelihood of the body constitution. |
| Readiness to Quit Ladder | Before and after the 4-week trial | Change from baseline Readiness to Quit Ladder at 4 weeks. The Readiness to Quit Ladder is rated from 1 to 10. The higher score indicated better readiness to quit smoking. |
| Pittsburgh sleep quality index | Before and after the 4-week trial | Change from baseline Pittsburgh sleep quality index at 4 weeks. The Pittsburgh sleep quality index ranged from 0 to 21. The higher score indicates more severe difficulties in sleep. |
| Tobacco Craving Questionnaire | Before and after the 4-week trial | Change from baseline Tobacco Craving Questionnaire at 4 weeks. The Tobacco Craving Questionnaire contains 47 items that ranged from 1-7. The higher score indicates the higher craving for tobacco. |
Countries
Taiwan
Contacts
Primary ContactChung-shan Hung, Ph.D
Outcome results
None listed