The Effect of Honey on Lessening the Withdrawal Symptoms

Study Overview
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Brief Summary
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This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution.

Official Title
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The Effect of Honey on Lessening the Withdrawal Symptoms According to the Body Constitution

Conditions
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Smoking Cessation, Withdrawal Symptoms

Intervention / Treatment
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* Dietary Supplement: Honey
* Dietary Supplement: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Participants need to drink honey every day for four weeks. | Dietary Supplement: Honey<br>* Participants need to drink honey every day for four weeks.<br>|
| Placebo Comparator: Control group<br>Participants need to drink water every day for four weeks. | Dietary Supplement: Water<br>* Participants need to drink water every day for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fagerstrom Test for Nicotine Dependence | 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. | Before and after the 4-week trial, 3 and 6 months after the trial | 
| Minnesota Nicotine Withdrawal Scale | 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. | Before and after the 4-week trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Constitution Questionnaire | 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. | Before and after the 4-week trial | 
| Tobacco Craving Questionnaire | 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. | Before and after the 4-week trial | 
| Depression Anxiety Stress Scales-21 | 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. | Before and after the 4-week trial | 
| WHOQOL-BREF | 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. | Before and after the 4-week trial | 
| Pittsburgh sleep quality index | 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. | Before and after the 4-week trial | 
| Readiness to Quit Ladder | 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. | Before and after the 4-week trial |